Absorb IV Randomized Controlled Trial
Study Details
Study Description
Brief Summary
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
ABSORB IV:
A. Primary Objective:
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To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
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To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
B. Secondary Objectives:
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To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
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To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.
The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.
Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Absorb BVS Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System |
Device: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm
Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
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Active Comparator: XIENCE Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only) |
Device: XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition
Stent lengths: 8, 12, 15, 18, 23, and 28 mm
For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
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Outcome Measures
Primary Outcome Measures
- Number of Participants With Target Lesion Failure (TLF) [30 days]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Secondary Outcome Measures
- TLF at 1-year, Non-inferiority Against the Control [1 year]
One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
- Angina at 1-year, Non-inferiority Against the Control [1 year]
Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
- Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) [In-hospital (≤ 7days)]
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
- Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) [In-hospital (≤ 7days)]
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [In-hospital (≤ 7 days post index procedure)]
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [30 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [90 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [180 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [270 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [1 year]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [2 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Death (Cardiac, Vascular, Non-cardiovascular) [5 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Participants With Myocardial Infarction (MI) [In-hospital (≤ 7 days post index procedure)]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [30 days]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [90 days]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [180 days]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [270 days]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [1 year]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [2 years]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [3 years]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [4 years]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Myocardial Infarction (MI) [5 years]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [In-hospital (≤ 7 days post index procedure)]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [30 days]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [90 days]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [180 days]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [270 days]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [1 year]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [2 year]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [3 years]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [4 years]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [5 years]
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
- Number of Participants With Target Lesion Revascularization (TLR) [In-hospital (≤ 7 days post index procedure)]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [30 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants withTarget Lesion Revascularization (TLR) [90 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [180 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [270 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [1 year]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [2 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [3 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [4 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Target Lesion Revascularization (TLR) [5 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
- Number of Participants With Ischemia Driven TLR (ID-TLR) [In-hospital (≤ 7 days post index procedure)]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [30 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [90 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [180 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [270 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [1 year]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [2 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [3 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [4 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Ischemia Driven TLR (ID-TLR) [5 years]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
- Number of Participants With Target Vessel Revascularization (TVR) [In-hospital (≤ 7 days post index procedure)]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [30 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [90 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [180 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [270 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [1 year]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [2 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [3 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [4 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With Target Vessel Revascularization (TVR) [5 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [In-hospital (≤ 7 days post index procedure)]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [30 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [90 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [180 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [270 days]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [1 year]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [2 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [3 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [4 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With ID-TVR Excluding TLR [5 years]
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
- Number of Participants With All Coronary Revascularization [In-hospital (≤ 7 days post index procedure)]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [30 days]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [90 days]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [180 days]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [270 days]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [1 year]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [2 years]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [3 years]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [4 years]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants With All Coronary Revascularization [5 years]
Revascularization includes TLR, TVR excluding TLR, and non TVR.
- Number of Participants Experienced All Death/All MI [In-hospital (≤ 7 days post index procedure)]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [30 days]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [90 days]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [180 days]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [270 days]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [1 year]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [2 years]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [3 years]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [4 years]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced All Death/All MI [5 years]
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
- Number of Participants Experienced Cardiac Death/All MI [In-hospital (≤ 7 days post index procedure)]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [30 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [90 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [180 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [270 days]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [1 year]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [2 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [3 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [4 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/All MI [5 years]
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [In-hospital (≤ 7 days post index procedure)]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [30 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [90 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [180 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [270 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [1 year]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [2 years]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [3 years]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [4 years]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [5 years]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [In-hospital (≤ 7 days post index procedure)]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) [30 days]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [90 days]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [180 days]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [270 days]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [1 year]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [2 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [3 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [4 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [5 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) [In-hospital (≤ 7 days post index procedure)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [30 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [90 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [180 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [270 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [1 year]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [2 years]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [3 years]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [4 years]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [5 years]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [In-hospital (≤ 7 days post index procedure)]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [30 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [90 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [180 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [270 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [1 year]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [2 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [3 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [4 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants Experienced Death/All MI/All Revascularization (DMR) [5 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) [0 - 24 hours post stent implantation]
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
- Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) [>24 hours - 30 days post stent implantation]
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
- Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [30 days - 1 year post stent implantation]
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
- Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) [0 to 730 Days]
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
- Number of Participants With Rehospitalization [30 days]
Coronary artery disease (CAD) related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [90 days]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [180 days]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [270 days]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [1 year]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [2 years]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [3 years]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [4 years]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Rehospitalization [5 years]
CAD related Cardiovascular, non-CAD related Non-cardiovascular related
- Number of Participants With Repeat Coronary Arteriography [In-hospital (≤ 7 days post index procedure)]
- Number of Participants With Repeat Coronary Arteriography [30 days]
- Number of Participants With Repeat Coronary Arteriography [90 days]
- Number of Participants With Repeat Coronary Arteriography [180 days]
- Number of Participants With Repeat Coronary Arteriography [270 days]
- Number of Participants With Repeat Coronary Arteriography [1 year]
- Number of Participants With Repeat Coronary Arteriography [2 years]
- Number of Participants With Repeat Coronary Arteriography [3 years]
- Number of Participants With Repeat Coronary Arteriography [4 years]
- Number of Participants With Repeat Coronary Arteriography [5 years]
- Landmark Analysis on MACE and TVF and Their Components [3-4 years]
- Landmark Analysis on MACE and TVF and Their Components [3-5 years]
- Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-4 years]
- Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-5 years]
- Number of Participants With Target Lesion Failure (TLF) [1 year]
The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Other Outcome Measures
- Patient Reported Outcomes [Baseline]
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Patient Reported Outcomes [1 month]
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Patient Reported Outcomes [6 months]
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Patient Reported Outcomes [1 year]
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Patient Reported Outcomes [3 years]
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Patient Reported Outcomes (PRO) [5 years]
Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
- Landmark Analysis on TLF and Components [3-4 years]
TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
- Landmark Analysis on TLF and Components [3-5 years]
TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Eligibility Criteria
Criteria
General Inclusion Criteria:
-
Subject must be at least 18 years of age.
-
Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
-
Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
-
Unstable angina or NSTEMI within 2 weeks of the index procedure.
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STEMI > 72 hours ≤ 2 weeks prior to the index procedure.
Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
- Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).
(Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)
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Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
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Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
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Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
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Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.
Angiographic Inclusion Criteria:
Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.
If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.
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Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).
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Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
-
Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.
General Exclusion Criteria:
-
Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
-
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
-
Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
-
Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
-
Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:
-
Subject requires coumadin or any other agent for chronic oral anticoagulation.
-
Subject is likely to become hemodynamically unstable due to their arrhythmia.
-
Subject has poor survival prognosis due to their arrhythmia.
-
Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
-
Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
-
Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
-
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
-
At the time of screening, the subject has a malignancy that is not in remission.
-
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
-
Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
-
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
-
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
-
Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
-
Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
-
Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
-
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
-
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
-
Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
-
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
-
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
-
Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Angiographic Exclusion Criteria:
All exclusion criteria apply to the target lesion(s) or target vessel(s).
-
Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):
-
Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
-
TIMI flow grade <3 (per visual estimation).
-
Any angiographic complication (e.g. distal embolization, side branch closure).
-
Any dissection NHLBI grade D-F.
-
Any chest pain lasting > 5 minutes.
-
Any ST-segment depression or elevation lasting > 5 minutes.
-
Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
-
Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
-
Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
-
Lesion involving a bifurcation with a:
-
side branch ≥ 2 mm in diameter, or
-
side branch with either an ostial or non-ostial lesion with diameter stenosis
50%, or
-
side branch requiring dilatation
-
Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or
XIENCE stent:
-
Extreme angulation (≥ 90°) proximal to or within the target lesion.
-
Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
-
Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
-
Lesion or vessel involves a myocardial bridge.
-
Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
-
Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
2 | Chandler Regional Medical Center | Chandler | Arizona | United States | 85224 |
3 | Mercy Gilbert Medical Center | Gilbert | Arizona | United States | 85297 |
4 | Scottsdale Healthcare | Scottsdale | Arizona | United States | 85258 |
5 | Arkansas Heart Hospital | Little Rock | Arkansas | United States | 72211 |
6 | John Muir Health Concord | Concord | California | United States | 94520 |
7 | Washington Hospital | Fremont | California | United States | 94538 |
8 | Scripps Memorial Hospital La Jolla | La Jolla | California | United States | 92037 |
9 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
10 | Univ Of California Davis Med Ctr | Sacramento | California | United States | 95817 |
11 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
12 | Stanford Hospital and Clinics | Stanford | California | United States | 94305 |
13 | Little Company Of Mary Hospital | Torrance | California | United States | 90503 |
14 | Medical Center of the Rockies | Loveland | Colorado | United States | 80538 |
15 | Yale-New Haven Hospital | New Haven | Connecticut | United States | 06510 |
16 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
17 | Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
18 | Baptist Medical Center Jacksonville | Jacksonville | Florida | United States | 32207 |
19 | UF Health Jacksonville | Jacksonville | Florida | United States | 32209 |
20 | Tallahassee Memorial Hospital | Tallahassee | Florida | United States | 32308 |
21 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
22 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
23 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
24 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
25 | Advocate Christ Medical Center | Oak Lawn | Illinois | United States | 60453 |
26 | St. John's Hospital | Springfield | Illinois | United States | 62769 |
27 | Elkhart General Hospital | Elkhart | Indiana | United States | 46514 |
28 | Franciscan St Francis Health | Indianapolis | Indiana | United States | 46237 |
29 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
30 | University Of Kentucky Hospital | Lexington | Kentucky | United States | 40506 |
31 | Jewish Hospital | Louisville | Kentucky | United States | 40202 |
32 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
33 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
34 | MedStar Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
35 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
36 | St. Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48197 |
37 | Harper University Hospital | Detroit | Michigan | United States | 48201 |
38 | St John Hospital & Medical Center | Detroit | Michigan | United States | 48236 |
39 | Northern Michigan Hospital | Petoskey | Michigan | United States | 49770 |
40 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
41 | North Mississippi Medical Center | Tupelo | Mississippi | United States | 38801 |
42 | Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP | Columbia | Missouri | United States | 65201 |
43 | Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
44 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
45 | St. Patrick Hospital | Missoula | Montana | United States | 59802 |
46 | Nebraska Heart Institute Heart Hosp. | Lincoln | Nebraska | United States | 68526 |
47 | CHI Health Bergan Mercy | Omaha | Nebraska | United States | 68124 |
48 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
49 | Cooper University Hospital | Camden | New Jersey | United States | 08103 |
50 | Our Lady of Lourdes Medical Center | Camden | New Jersey | United States | 08103 |
51 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
52 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
53 | NewYork-Presbyterian/Queens | Flushing | New York | United States | 11355 |
54 | NYP Weill Cornell Medical Center | New York | New York | United States | 10021 |
55 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
56 | Columbia University Medical Center | New York | New York | United States | 10032 |
57 | Rochester General Hospital | Rochester | New York | United States | 14621 |
58 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
59 | St. Joseph's Hospital Health Center | Syracuse | New York | United States | 13203 |
60 | Carolinas Medical Center-Northeast | Charlotte | North Carolina | United States | 28203 |
61 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
62 | Novant Health Heart & Vascular Institute/Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
63 | Carolinas Medical Center-Pineville | Charlotte | North Carolina | United States | 28210 |
64 | Rex Hospital, Inc. | Raleigh | North Carolina | United States | 27607 |
65 | WakeMed | Raleigh | North Carolina | United States | 27610 |
66 | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States | 27103 |
67 | Aultman Hospital | Canton | Ohio | United States | 44710 |
68 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
69 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
70 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
71 | Mercy St. Vincent Medical Center | Toledo | Ohio | United States | 43608 |
72 | Genesis Hospital | Zanesville | Ohio | United States | 43701 |
73 | Integris Baptist Medical Center, Inc. | Oklahoma City | Oklahoma | United States | 73112 |
74 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
75 | Holy Spirit Hospital | Camp Hill | Pennsylvania | United States | 17011 |
76 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
77 | Doylestown Hospital | Doylestown | Pennsylvania | United States | 18901 |
78 | Pinnacle Health Hospitals | Harrisburg | Pennsylvania | United States | 17105-8700 |
79 | Forbes Hospital | Monroeville | Pennsylvania | United States | 15146 |
80 | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
81 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
82 | Upmc Presbyterian | Pittsburgh | Pennsylvania | United States | 15213 |
83 | St. Joseph Medical Center | Reading | Pennsylvania | United States | 19605 |
84 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
85 | The Miriam Hospital | Providence | Rhode Island | United States | 02906 |
86 | Anmed Health Medical Center | Anderson | South Carolina | United States | 29621 |
87 | Providence Hospital | Columbia | South Carolina | United States | 29204 |
88 | Wellmont Holston Valley Medical Center | Kingsport | Tennessee | United States | 37660 |
89 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
90 | Northwest Texas Healthcare System | Amarillo | Texas | United States | 79106 |
91 | Seton Medical Center | Austin | Texas | United States | 78705 |
92 | Baylor Heart and Vascular Hospital | Dallas | Texas | United States | 75226 |
93 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
94 | East Texas Medical Center | Tyler | Texas | United States | 75701 |
95 | Carilion Roanoke Memorial Hospital | Roanoke | Virginia | United States | 24014 |
96 | Winchester Medical Center | Winchester | Virginia | United States | 22601 |
97 | Providence Reg Med Ctr Everett | Everett | Washington | United States | 98201 |
98 | Medstar Health Research Institute/ Medstar Washington Hospital Center | Northwest | Washington | United States | 20010 |
99 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
100 | The Prince Charles Hospital | Brisbane | Queensland | Australia | 4032 |
101 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
102 | St Vincent's Hospital Melbourne | Fitzroy | Victoria | Australia | 3065 |
103 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | 6150 |
104 | Royal Perth Hospital | Perth | Western Australia | Australia | 6001 |
105 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
106 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T 1C8 |
107 | Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | Canada | H4J 1C5 |
108 | CHUM-Hotel Dieu | Montréal | Quebec | Canada | |
109 | Universitatsklinikum Freiburg | Freiburg | Baden-Württemberg | Germany | 79106 |
110 | Universitätsklinikum Ulm | Ulm | Baden-Württemberg | Germany | 89081 |
111 | Kliniken Oberallgau gGmbH | Immenstadt | Bavaria | Germany | 87509 |
112 | Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH | Kempten-Allgau | Bavaria | Germany | 87439 |
113 | Immanuel Klinikum Bernau Herzzentrum Brandenburg | Bernau | Berlin | Germany | 16321 |
114 | University Giessen | Giessen | Hesse | Germany | 35392 |
115 | Klinikum Oldenburg | Oldenburg | Lower Saxony | Germany | 26133 |
116 | Universitatsklinikum Bonn | Bonn | North Rhine-Westphalia | Germany | 53105 |
117 | Elisabeth-Krankenhaus | Essen | North Rhine-Westphalia | Germany | 45138 |
118 | Johannes Gutenberg-Universitaet | Mainz | Rhineland-Palatinate | Germany | 55131 |
119 | Segeberger Kliniken GmbH - Herzzentrum | Bad Segeberg | Schleswig-Holstein | Germany | 23795 |
120 | National Heart Centre, Singapore, Pte, Ltd. | Singapore | Singapore | 169609 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Chair: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
- Principal Investigator: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
- Principal Investigator: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH
- Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH
Study Documents (Full-Text)
More Information
Publications
None provided.- 10-392 C
Study Results
Participant Flow
Recruitment Details | A total of 2604 subjects were randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 1-year follow-up visit occurred on March 31, 2018. The database was then cleaned and locked, and data extraction for the 2-year analysis occurred on June 04, 2019. |
---|---|
Pre-assignment Detail | The last 2-year follow-up visit occurred on 16 April, 2019. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Period Title: Overall Study | ||
STARTED | 1296 | 1308 |
COMPLETED | 1205 | 1231 |
NOT COMPLETED | 91 | 77 |
Baseline Characteristics
Arm/Group Title | Absorb BVS | XIENCE | Total |
---|---|---|---|
Arm/Group Description | Subjects receiving public) Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) | Total of all reporting groups |
Overall Participants | 1296 | 1308 | 2604 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.1
(10.1)
|
62.2
(10.3)
|
62.65
(10.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
369
28.5%
|
361
27.6%
|
730
28%
|
Male |
927
71.5%
|
947
72.4%
|
1874
72%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
40
3.1%
|
29
2.2%
|
69
2.6%
|
Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
1256
96.9%
|
1279
97.8%
|
2535
97.4%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
4
0.3%
|
8
0.6%
|
12
0.5%
|
Asian |
30
2.3%
|
36
2.8%
|
66
2.5%
|
Native Hawaiian or Other Pacific Islander |
11
0.8%
|
4
0.3%
|
15
0.6%
|
Black or African American |
71
5.5%
|
61
4.7%
|
132
5.1%
|
White |
1135
87.6%
|
1160
88.7%
|
2295
88.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
45
3.5%
|
39
3%
|
84
3.2%
|
Region of Enrollment (participants) [Number] | |||
Canada |
28
2.2%
|
26
2%
|
54
2.1%
|
United States |
1021
78.8%
|
1041
79.6%
|
2062
79.2%
|
Australia |
80
6.2%
|
68
5.2%
|
148
5.7%
|
Germany |
164
12.7%
|
171
13.1%
|
335
12.9%
|
Singapore |
3
0.2%
|
2
0.2%
|
5
0.2%
|
Prior Coronary Intervention (Count of Participants) | |||
Count of Participants [Participants] |
390
30.1%
|
435
33.3%
|
825
31.7%
|
Outcome Measures
Title | Number of Participants With Target Lesion Failure (TLF) |
---|---|
Description | Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR)) |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
64
4.9%
|
48
3.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are: H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE < ∆TLF. | |
Type of Statistical Test | Non-Inferiority | |
Comments | One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025. | |
Statistical Test of Hypothesis | p-Value | 0.0244 |
Comments | ||
Method | Farrington-Manning | |
Comments |
Title | TLF at 1-year, Non-inferiority Against the Control |
---|---|
Description | One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
98
7.6%
|
82
6.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025. | |
Statistical Test of Hypothesis | p-Value | 0.0006 |
Comments | ||
Method | Farrington-Manning | |
Comments |
Title | Angina at 1-year, Non-inferiority Against the Control |
---|---|
Description | Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1249 | 1261 |
Count of Participants [Participants] |
253
19.5%
|
259
19.8%
|
Title | Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) |
---|---|
Description | Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. |
Time Frame | In-hospital (≤ 7days) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1303 |
Measure Target lesions | 1424 | 1450 |
Number [Percentage of target lesions] |
94.6
|
99.0
|
Title | Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) |
---|---|
Description | Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). |
Time Frame | In-hospital (≤ 7days) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1303 |
Count of Participants [Participants] |
1203
92.8%
|
1250
95.6%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
1
0.1%
|
0
0%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
1
0.1%
|
1
0.1%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
5
0.4%
|
5
0.4%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
7
0.5%
|
8
0.6%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
10
0.8%
|
11
0.8%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
16
1.2%
|
14
1.1%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
22
1.7%
|
22
1.7%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
50
3.9%
|
43
3.3%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
58
4.5%
|
47
3.6%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
66
5.1%
|
50
3.8%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
70
5.4%
|
56
4.3%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
75
5.8%
|
62
4.7%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
80
6.2%
|
65
5%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
104
8%
|
86
6.6%
|
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
50
3.9%
|
43
3.3%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
57
4.4%
|
47
3.6%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
63
4.9%
|
48
3.7%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
67
5.2%
|
53
4.1%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
71
5.5%
|
56
4.3%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
75
5.8%
|
58
4.4%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 2 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
94
7.3%
|
72
5.5%
|
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) |
---|---|
Description | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
8
0.6%
|
1
0.1%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
14
1.1%
|
3
0.2%
|
Title | Number of Participants withTarget Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
16
1.2%
|
4
0.3%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
23
1.8%
|
11
0.8%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
33
2.5%
|
15
1.1%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
38
2.9%
|
24
1.8%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
69
5.3%
|
36
2.8%
|
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Lesion Revascularization (TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
8
0.6%
|
1
0.1%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
13
1%
|
3
0.2%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
15
1.2%
|
4
0.3%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
22
1.7%
|
11
0.8%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
32
2.5%
|
15
1.1%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
37
2.9%
|
24
1.8%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
66
5.1%
|
36
2.8%
|
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Ischemia Driven TLR (ID-TLR) |
---|---|
Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
3
0.2%
|
0
0%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
5
0.4%
|
1
0.1%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
10
0.8%
|
6
0.5%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
14
1.1%
|
14
1.1%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
19
1.5%
|
16
1.2%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
22
1.7%
|
18
1.4%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
42
3.2%
|
36
2.8%
|
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Vessel Revascularization (TVR) |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
3
0.2%
|
0
0%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
5
0.4%
|
1
0.1%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
10
0.8%
|
6
0.5%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
14
1.1%
|
14
1.1%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
19
1.5%
|
16
1.2%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
22
1.7%
|
18
1.4%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
40
3.1%
|
35
2.7%
|
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With ID-TVR Excluding TLR |
---|---|
Description | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
10
0.8%
|
4
0.3%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
19
1.5%
|
8
0.6%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
28
2.2%
|
15
1.1%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
41
3.2%
|
30
2.3%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
54
4.2%
|
39
3%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
63
4.9%
|
50
3.8%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
114
8.8%
|
86
6.6%
|
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With All Coronary Revascularization |
---|---|
Description | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
51
3.9%
|
43
3.3%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
59
4.6%
|
48
3.7%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
69
5.3%
|
55
4.2%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
74
5.7%
|
64
4.9%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
80
6.2%
|
72
5.5%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
89
6.9%
|
78
6%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
116
9%
|
106
8.1%
|
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced All Death/All MI |
---|---|
Description | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
51
3.9%
|
43
3.3%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
59
4.6%
|
47
3.6%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
67
5.2%
|
53
4.1%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
71
5.5%
|
61
4.7%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
77
5.9%
|
68
5.2%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
83
6.4%
|
72
5.5%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
107
8.3%
|
96
7.3%
|
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI |
---|---|
Description | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
57
4.4%
|
44
3.4%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
64
4.9%
|
48
3.7%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
71
5.5%
|
53
4.1%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
77
5.9%
|
64
4.9%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
90
6.9%
|
71
5.4%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
98
7.6%
|
82
6.3%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
137
10.6%
|
105
8%
|
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
57
4.4%
|
44
3.4%
|
Title | Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
65
5%
|
48
3.7%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
74
5.7%
|
55
4.2%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
80
6.2%
|
67
5.1%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
93
7.2%
|
77
5.9%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
102
7.9%
|
88
6.7%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
145
11.2%
|
119
9.1%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) |
---|---|
Description | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
57
4.4%
|
44
3.4%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
66
5.1%
|
48
3.7%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
77
5.9%
|
59
4.5%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
86
6.6%
|
75
5.7%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
101
7.8%
|
86
6.6%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
111
8.6%
|
99
7.6%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
160
12.3%
|
136
10.4%
|
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) |
---|---|
Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1304 |
Count of Participants [Participants] |
57
4.4%
|
46
3.5%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1303 |
Count of Participants [Participants] |
67
5.2%
|
53
4.1%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1286 | 1300 |
Count of Participants [Participants] |
81
6.3%
|
65
5%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1291 |
Count of Participants [Participants] |
94
7.3%
|
82
6.3%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1264 | 1279 |
Count of Participants [Participants] |
110
8.5%
|
97
7.4%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1272 |
Count of Participants [Participants] |
124
9.6%
|
112
8.6%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1232 | 1255 |
Count of Participants [Participants] |
182
14%
|
158
12.1%
|
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants Experienced Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) |
---|---|
Description | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation). |
Time Frame | 0 - 24 hours post stent implantation |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1291 | 1305 |
Definite |
3
0.2%
|
0
0%
|
Definite/Probable |
4
0.3%
|
0
0%
|
Probable |
1
0.1%
|
0
0%
|
Title | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) |
---|---|
Description | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation). |
Time Frame | >24 hours - 30 days post stent implantation |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1287 | 1301 |
Definite |
4
0.3%
|
2
0.2%
|
Definite/Probable |
4
0.3%
|
2
0.2%
|
Probable |
0
0%
|
0
0%
|
Title | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) |
---|---|
Description | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation). |
Time Frame | 30 days - 1 year post stent implantation |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1238 | 1258 |
Definite |
1
0.1%
|
2
0.2%
|
Definite/Probable |
1
0.1%
|
2
0.2%
|
Probable |
0
0%
|
0
0%
|
Title | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) |
---|---|
Description | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained |
Time Frame | 0 to 730 Days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1210 | 1231 |
Definite |
11
0.8%
|
6
0.5%
|
Definite/Probable |
12
0.9%
|
6
0.5%
|
Probable |
1
0.1%
|
0
0%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | Coronary artery disease (CAD) related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1302 |
Count of Participants [Participants] |
65
5%
|
59
4.5%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1285 | 1298 |
Count of Participants [Participants] |
111
8.6%
|
122
9.3%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1283 | 1290 |
Count of Participants [Participants] |
177
13.7%
|
177
13.5%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1266 | 1278 |
Count of Participants [Participants] |
226
17.4%
|
236
18%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1254 | 1271 |
Count of Participants [Participants] |
276
21.3%
|
288
22%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1238 | 1254 |
Count of Participants [Participants] |
440
34%
|
445
34%
|
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Rehospitalization |
---|---|
Description | CAD related Cardiovascular, non-CAD related Non-cardiovascular related |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | In-hospital (≤ 7 days post index procedure) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1290 | 1304 |
Count of Participants [Participants] |
4
0.3%
|
7
0.5%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1288 | 1301 |
Count of Participants [Participants] |
18
1.4%
|
21
1.6%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 90 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1282 | 1295 |
Count of Participants [Participants] |
33
2.5%
|
40
3.1%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 180 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1279 | 1283 |
Count of Participants [Participants] |
57
4.4%
|
64
4.9%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 270 days |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1260 | 1270 |
Count of Participants [Participants] |
71
5.5%
|
86
6.6%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1242 | 1260 |
Count of Participants [Participants] |
84
6.5%
|
102
7.8%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System | Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) |
Measure Participants | 1218 | 1236 |
Count of Participants [Participants] |
140
10.8%
|
160
12.2%
|
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Repeat Coronary Arteriography |
---|---|
Description | |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on MACE and TVF and Their Components |
---|---|
Description | |
Time Frame | 3-4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on MACE and TVF and Their Components |
---|---|
Description | |
Time Frame | 3-5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) |
---|---|
Description | |
Time Frame | 3-4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) |
---|---|
Description | |
Time Frame | 3-5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Participants With Target Lesion Failure (TLF) |
---|---|
Description | The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV) |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes |
---|---|
Description | Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes |
---|---|
Description | Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | 1 month |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes |
---|---|
Description | Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes |
---|---|
Description | Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes |
---|---|
Description | Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Patient Reported Outcomes (PRO) |
---|---|
Description | Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial. |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on TLF and Components |
---|---|
Description | TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 3-4 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Landmark Analysis on TLF and Components |
---|---|
Description | TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 3-5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | 2 years | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Absorb BVS | XIENCE | ||
Arm/Group Description | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition | ||
All Cause Mortality |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 22/1296 (1.7%) | 22/1308 (1.7%) | ||
Serious Adverse Events |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 637/1296 (49.2%) | 588/1308 (45%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 4/1296 (0.3%) | 5/1308 (0.4%) | ||
HAEMORRHAGIC ANAEMIA | 0/1296 (0%) | 3/1308 (0.2%) | ||
IRON DEFICIENCY ANAEMIA | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
NORMOCHROMIC NORMOCYTIC ANAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PANCYTOPENIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
THROMBOCYTOPENIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
Cardiac disorders | ||||
ACUTE CORONARY SYNDROME | 8/1296 (0.6%) | 3/1308 (0.2%) | ||
ACUTE LEFT VENTRICULAR FAILURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ACUTE MYOCARDIAL INFARCTION | 16/1296 (1.2%) | 24/1308 (1.8%) | ||
ANGINA PECTORIS | 94/1296 (7.3%) | 74/1308 (5.7%) | ||
ANGINA UNSTABLE | 29/1296 (2.2%) | 39/1308 (3%) | ||
AORTIC VALVE INCOMPETENCE | 1/1296 (0.1%) | 0/1308 (0%) | ||
AORTIC VALVE STENOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIOSCLEROSIS CORONARY ARTERY | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
ARTERIOSPASM CORONARY | 0/1296 (0%) | 1/1308 (0.1%) | ||
ATRIAL FIBRILLATION | 19/1296 (1.5%) | 9/1308 (0.7%) | ||
ATRIAL FLUTTER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ATRIOVENTRICULAR BLOCK | 0/1296 (0%) | 1/1308 (0.1%) | ||
ATRIOVENTRICULAR BLOCK COMPLETE | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BRADYCARDIA | 0/1296 (0%) | 3/1308 (0.2%) | ||
BUNDLE BRANCH BLOCK LEFT | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC ARREST | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE | 6/1296 (0.5%) | 1/1308 (0.1%) | ||
CARDIAC FAILURE ACUTE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
CARDIAC FAILURE CHRONIC | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE CONGESTIVE | 11/1296 (0.8%) | 10/1308 (0.8%) | ||
CARDIAC PERFORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIO-RESPIRATORY ARREST | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIOGENIC SHOCK | 5/1296 (0.4%) | 0/1308 (0%) | ||
CARDIOMYOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHRONOTROPIC INCOMPETENCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONGESTIVE CARDIOMYOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CORONARY ARTERY DISEASE | 26/1296 (2%) | 16/1308 (1.2%) | ||
CORONARY ARTERY DISSECTION | 40/1296 (3.1%) | 17/1308 (1.3%) | ||
CORONARY ARTERY EMBOLISM | 1/1296 (0.1%) | 0/1308 (0%) | ||
CORONARY ARTERY OCCLUSION | 0/1296 (0%) | 3/1308 (0.2%) | ||
CORONARY ARTERY PERFORATION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CORONARY ARTERY STENOSIS | 7/1296 (0.5%) | 3/1308 (0.2%) | ||
HYPERTENSIVE HEART DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERTROPHIC CARDIOMYOPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
INTRACARDIAC THROMBUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ISCHAEMIC CARDIOMYOPATHY | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
MITRAL VALVE INCOMPETENCE | 2/1296 (0.2%) | 0/1308 (0%) | ||
MYOCARDIAL INFARCTION | 34/1296 (2.6%) | 23/1308 (1.8%) | ||
MYOCARDIAL ISCHAEMIA | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
MYOPERICARDITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PALPITATIONS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PERICARDIAL EFFUSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
PERICARDITIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PRINZMETAL ANGINA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SICK SINUS SYNDROME | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
SUPRAVENTRICULAR TACHYCARDIA | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
TACHYCARDIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
VENTRICULAR FIBRILLATION | 4/1296 (0.3%) | 0/1308 (0%) | ||
VENTRICULAR TACHYCARDIA | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
Congenital, familial and genetic disorders | ||||
CONGENITAL ARTERIAL MALFORMATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CORNEAL DYSTROPHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
PHIMOSIS | 0/1296 (0%) | 0/1308 (0%) | ||
Ear and labyrinth disorders | ||||
VERTIGO | 0/1296 (0%) | 1/1308 (0.1%) | ||
VERTIGO POSITIONAL | 0/1296 (0%) | 2/1308 (0.2%) | ||
Endocrine disorders | ||||
CARCINOID SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
GOITRE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERPARATHYROIDISM | 0/1296 (0%) | 1/1308 (0.1%) | ||
THYROID MASS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Eye disorders | ||||
CATARACT | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
MACULAR FIBROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
RETINAL ARTERY EMBOLISM | 0/1296 (0%) | 1/1308 (0.1%) | ||
RETINAL DETACHMENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
TOLOSA-HUNT SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL PAIN | 5/1296 (0.4%) | 4/1308 (0.3%) | ||
ABDOMINAL PAIN LOWER | 0/1296 (0%) | 1/1308 (0.1%) | ||
ASCITES | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
BARRETT'S OESOPHAGUS | 0/1296 (0%) | 1/1308 (0.1%) | ||
COLITIS | 4/1296 (0.3%) | 0/1308 (0%) | ||
COLITIS ISCHAEMIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
COLITIS ULCERATIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLONIC POLYP | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CONSTIPATION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CROHN'S DISEASE | 1/1296 (0.1%) | 0/1308 (0%) | ||
DENTAL CARIES | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIVERTICULITIS INTESTINAL HAEMORRHAGIC | 0/1296 (0%) | 3/1308 (0.2%) | ||
DIVERTICULUM | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIVERTICULUM INTESTINAL | 0/1296 (0%) | 2/1308 (0.2%) | ||
DIVERTICULUM INTESTINAL HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
DUODENAL ULCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
DUODENAL ULCER PERFORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSPEPSIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
FAECALOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRIC ULCER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
GASTRIC ULCER HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRITIS | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
GASTRITIS EROSIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRITIS HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTROINTESTINAL HAEMORRHAGE | 6/1296 (0.5%) | 11/1308 (0.8%) | ||
GASTROINTESTINAL ULCER HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROOESOPHAGEAL REFLUX DISEASE | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
GINGIVAL BLEEDING | 1/1296 (0.1%) | 0/1308 (0%) | ||
HAEMATEMESIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
HAEMORRHOIDAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HAEMORRHOIDS | 1/1296 (0.1%) | 0/1308 (0%) | ||
HIATUS HERNIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
ILEUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
IMPAIRED GASTRIC EMPTYING | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
INGUINAL HERNIA | 4/1296 (0.3%) | 1/1308 (0.1%) | ||
INTESTINAL MASS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LOWER GASTROINTESTINAL HAEMORRHAGE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
MALLORY-WEISS SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
NAUSEA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
OESOPHAGEAL STENOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PANCREATITIS | 0/1296 (0%) | 3/1308 (0.2%) | ||
PANCREATITIS ACUTE | 0/1296 (0%) | 3/1308 (0.2%) | ||
PANCREATITIS CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
RECTAL HAEMORRHAGE | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
RETROPERITONEAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
SMALL INTESTINAL OBSTRUCTION | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
SPIGELIAN HERNIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
STOMATITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
UMBILICAL HERNIA | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
UPPER GASTROINTESTINAL HAEMORRHAGE | 3/1296 (0.2%) | 0/1308 (0%) | ||
VOLVULUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
General disorders | ||||
ADVERSE DRUG REACTION | 3/1296 (0.2%) | 8/1308 (0.6%) | ||
ASTHENIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CATHETER SITE HAEMATOMA | 4/1296 (0.3%) | 1/1308 (0.1%) | ||
CATHETER SITE NECROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHEST DISCOMFORT | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
CHEST PAIN | 23/1296 (1.8%) | 22/1308 (1.7%) | ||
COMPLICATION OF DEVICE REMOVAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
DEATH | 1/1296 (0.1%) | 4/1308 (0.3%) | ||
DEVICE FAILURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
DEVICE ISSUE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEVICE LEAD DAMAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
DEVICE MALFUNCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
EARLY SATIETY | 0/1296 (0%) | 1/1308 (0.1%) | ||
FACIAL PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
FATIGUE | 2/1296 (0.2%) | 0/1308 (0%) | ||
IMPAIRED HEALING | 0/1296 (0%) | 2/1308 (0.2%) | ||
MEDICAL DEVICE SITE REACTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
NON-CARDIAC CHEST PAIN | 48/1296 (3.7%) | 58/1308 (4.4%) | ||
PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
PYREXIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
THROMBOSIS IN DEVICE | 8/1296 (0.6%) | 6/1308 (0.5%) | ||
ULCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
Hepatobiliary disorders | ||||
ACUTE HEPATIC FAILURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT OBSTRUCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT STONE | 0/1296 (0%) | 3/1308 (0.2%) | ||
CHOLANGITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
CHOLANGITIS ACUTE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CHOLECYSTITIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
CHOLECYSTITIS ACUTE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CHOLECYSTITIS CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHOLELITHIASIS | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
GALLBLADDER DISORDER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HEPATIC CIRRHOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC STEATOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ISCHAEMIC HEPATITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
Immune system disorders | ||||
ANAPHYLACTIC REACTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DRUG HYPERSENSITIVITY | 1/1296 (0.1%) | 0/1308 (0%) | ||
Infections and infestations | ||||
ABSCESS LIMB | 1/1296 (0.1%) | 0/1308 (0%) | ||
ABSCESS NECK | 1/1296 (0.1%) | 0/1308 (0%) | ||
ABSCESS ORAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
APPENDICITIS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
ARTERIOVENOUS GRAFT SITE INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTHRITIS INFECTIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACTERIAL SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRONCHITIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
BRONCHITIS VIRAL | 0/1296 (0%) | 3/1308 (0.2%) | ||
BRONCHOPNEUMONIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
CELLULITIS | 4/1296 (0.3%) | 4/1308 (0.3%) | ||
CHOLECYSTITIS INFECTIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CLOSTRIDIAL INFECTION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CLOSTRIDIUM COLITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
DIABETIC FOOT INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIVERTICULITIS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
EAR INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
EMPYEMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
ESCHERICHIA BACTERAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ESCHERICHIA INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ESCHERICHIA SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
ESCHERICHIA URINARY TRACT INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
EXTRADURAL ABSCESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
GANGRENE | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTROENTERITIS | 1/1296 (0.1%) | 6/1308 (0.5%) | ||
INFECTIOUS PLEURAL EFFUSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
INFLUENZA | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
LABYRINTHITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
LIVER ABSCESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LOBAR PNEUMONIA | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
LUNG INFECTION PSEUDOMONAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
NECROTISING FASCIITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OSTEOMYELITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PNEUMONIA | 13/1296 (1%) | 14/1308 (1.1%) | ||
POSTOPERATIVE WOUND INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
PYELONEPHRITIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PYELONEPHRITIS ACUTE | 1/1296 (0.1%) | 0/1308 (0%) | ||
SEPSIS | 8/1296 (0.6%) | 5/1308 (0.4%) | ||
SEPTIC SHOCK | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
STAPHYLOCOCCAL SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
TOOTH INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
URINARY TRACT INFECTION | 2/1296 (0.2%) | 5/1308 (0.4%) | ||
UROSEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
VIRAL INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
VIRAL LABYRINTHITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
WOUND INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
WOUND INFECTION BACTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
Injury, poisoning and procedural complications | ||||
ACETABULUM FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANASTOMOTIC ULCER HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANKLE FRACTURE | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
ARTHROPOD STING | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACK INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC PROCEDURE COMPLICATION | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
CATHETER SITE HAEMATOMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CERVICAL VERTEBRAL FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
COMMINUTED FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONFUSION POSTOPERATIVE | 2/1296 (0.2%) | 0/1308 (0%) | ||
CORONARY ARTERY RESTENOSIS | 31/1296 (2.4%) | 19/1308 (1.5%) | ||
FACIAL BONES FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
FALL | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
FEMUR FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
FOOT FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
FOREARM FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL STOMA COMPLICATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
HAND FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEAT EXHAUSTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
HIP FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
IN-STENT ARTERIAL RESTENOSIS | 2/1296 (0.2%) | 0/1308 (0%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
INJURY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
JOINT DISLOCATION | 0/1296 (0%) | 2/1308 (0.2%) | ||
LACERATION | 2/1296 (0.2%) | 0/1308 (0%) | ||
LIGAMENT RUPTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIMB INJURY | 1/1296 (0.1%) | 0/1308 (0%) | ||
OVERDOSE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PATELLA FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
PELVIC FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
PELVIC ORGAN INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
PERIPROSTHETIC FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
PLAQUE SHIFT | 0/1296 (0%) | 1/1308 (0.1%) | ||
POISONING | 0/1296 (0%) | 1/1308 (0.1%) | ||
POISONING DELIBERATE | 0/1296 (0%) | 1/1308 (0.1%) | ||
POST PROCEDURAL COMPLICATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
POST PROCEDURAL MYOCARDIAL INFARCTION | 11/1296 (0.8%) | 6/1308 (0.5%) | ||
POST-TRAUMATIC PAIN | 0/1296 (0%) | 3/1308 (0.2%) | ||
POSTOPERATIVE ILEUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
POSTOPERATIVE RESPIRATORY DISTRESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PROCEDURAL HYPERTENSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
PROCEDURAL PAIN | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PROCEDURAL VOMITING | 1/1296 (0.1%) | 0/1308 (0%) | ||
RADIUS FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
RIB FRACTURE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ROAD TRAFFIC ACCIDENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
SPINAL COMPRESSION FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
STAB WOUND | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUBDURAL HAEMATOMA | 0/1296 (0%) | 3/1308 (0.2%) | ||
TENDON RUPTURE | 2/1296 (0.2%) | 0/1308 (0%) | ||
THORACIC VERTEBRAL FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
TRAUMATIC HAEMATOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
TRAUMATIC INTRACRANIAL HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
TRAUMATIC LUNG INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY RETENTION POSTOPERATIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
VASCULAR GRAFT COMPLICATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
VASCULAR GRAFT OCCLUSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
VASCULAR PSEUDOANEURYSM | 3/1296 (0.2%) | 5/1308 (0.4%) | ||
WOUND DEHISCENCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
WRIST FRACTURE | 0/1296 (0%) | 2/1308 (0.2%) | ||
Investigations | ||||
ARTERIOGRAM CORONARY | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLOOD CREATINE PHOSPHOKINASE INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD CREATINE PHOSPHOKINASE MB INCREASED | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
BLOOD GLUCOSE DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD GLUCOSE INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD PRESSURE INCREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIAC ENZYMES INCREASED | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
CARDIAC STRESS TEST ABNORMAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
EJECTION FRACTION DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
ELECTROCARDIOGRAM ABNORMAL | 2/1296 (0.2%) | 0/1308 (0%) | ||
GLYCOSYLATED HAEMOGLOBIN INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
HAEMOGLOBIN DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
TRANSAMINASES INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
TROPONIN INCREASED | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
Metabolism and nutrition disorders | ||||
DEHYDRATION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
DIABETES MELLITUS | 0/1296 (0%) | 1/1308 (0.1%) | ||
DIABETIC KETOACIDOSIS | 1/1296 (0.1%) | 5/1308 (0.4%) | ||
FAILURE TO THRIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPERCALCAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERGLYCAEMIA | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
HYPERKALAEMIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
HYPOGLYCAEMIA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HYPONATRAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPOVOLAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
KETOACIDOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LACTIC ACIDOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OBESITY | 0/1296 (0%) | 1/1308 (0.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
ARTHRITIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
ARTHROPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACK PAIN | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
BURSITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CERVICAL SPINAL STENOSIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
COSTOCHONDRITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
FOOT DEFORMITY | 2/1296 (0.2%) | 0/1308 (0%) | ||
INTERVERTEBRAL DISC DEGENERATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
INTERVERTEBRAL DISC PROTRUSION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
JOINT SWELLING | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUMBAR SPINAL STENOSIS | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
MUSCLE SPASMS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
MUSCULAR WEAKNESS | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
MUSCULOSKELETAL CHEST PAIN | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
MUSCULOSKELETAL PAIN | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
MYALGIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
NECK PAIN | 2/1296 (0.2%) | 0/1308 (0%) | ||
OSTEOARTHRITIS | 11/1296 (0.8%) | 11/1308 (0.8%) | ||
OSTEOCHONDROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PAIN IN EXTREMITY | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
RHABDOMYOLYSIS | 2/1296 (0.2%) | 0/1308 (0%) | ||
ROTATOR CUFF SYNDROME | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
SPINAL COLUMN STENOSIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
SPINAL DISORDER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SPINAL OSTEOARTHRITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
TENDONITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
VERTEBRAL FORAMINAL STENOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
ACUTE PROMYELOCYTIC LEUKAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
B-CELL LYMPHOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
B-CELL LYMPHOMA STAGE I | 0/1296 (0%) | 1/1308 (0.1%) | ||
B-CELL LYMPHOMA STAGE IV | 0/1296 (0%) | 1/1308 (0.1%) | ||
BASAL CELL CARCINOMA | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
BENIGN SOFT TISSUE NEOPLASM | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT CANCER | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLADDER CANCER | 1/1296 (0.1%) | 0/1308 (0%) | ||
BOWEN'S DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
BREAST CANCER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
BREAST CANCER IN SITU | 1/1296 (0.1%) | 0/1308 (0%) | ||
BREAST CANCER STAGE II | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLON ADENOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLON CANCER | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
ENDOMETRIAL CANCER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ENDOMETRIAL CANCER METASTATIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL STROMAL TUMOUR | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC NEOPLASM MALIGNANT RECURRENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
INTESTINAL ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG CANCER METASTATIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV | 0/1296 (0%) | 1/1308 (0.1%) | ||
LUNG NEOPLASM | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG NEOPLASM MALIGNANT | 3/1296 (0.2%) | 0/1308 (0%) | ||
LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALIGNANT GLIOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALIGNANT MELANOMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
MALIGNANT PLEURAL EFFUSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
MANTLE CELL LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
METASTASES TO CENTRAL NERVOUS SYSTEM | 1/1296 (0.1%) | 0/1308 (0%) | ||
MUELLER'S MIXED TUMOUR | 1/1296 (0.1%) | 0/1308 (0%) | ||
MULTIPLE MYELOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MYELODYSPLASTIC SYNDROME | 2/1296 (0.2%) | 0/1308 (0%) | ||
NEOPLASM MALIGNANT | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
NEUROENDOCRINE CARCINOMA METASTATIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
NON-HODGKIN'S LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
OESOPHAGEAL CARCINOMA | 0/1296 (0%) | 2/1308 (0.2%) | ||
OROPHARYNGEAL CANCER STAGE UNSPECIFIED | 0/1296 (0%) | 1/1308 (0.1%) | ||
OVARIAN CANCER METASTATIC | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
OVARIAN CANCER STAGE III | 1/1296 (0.1%) | 0/1308 (0%) | ||
PANCREATIC CARCINOMA METASTATIC | 0/1296 (0%) | 2/1308 (0.2%) | ||
PARATHYROID TUMOUR BENIGN | 0/1296 (0%) | 1/1308 (0.1%) | ||
PLASMACYTOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PROSTATE CANCER | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
RENAL CELL CARCINOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
SALIVARY GLAND CANCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SALIVARY GLAND NEOPLASM | 1/1296 (0.1%) | 0/1308 (0%) | ||
SMALL CELL LUNG CANCER STAGE UNSPECIFIED | 1/1296 (0.1%) | 0/1308 (0%) | ||
SQUAMOUS CELL CARCINOMA OF SKIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
TRANSITIONAL CELL CARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
URETERIC CANCER RECURRENT | 1/1296 (0.1%) | 0/1308 (0%) | ||
Nervous system disorders | ||||
APHASIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRAIN INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRAIN MASS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CAROTID ARTERY STENOSIS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
CARPAL TUNNEL SYNDROME | 1/1296 (0.1%) | 0/1308 (0%) | ||
CENTRAL NERVOUS SYSTEM LESION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CEREBELLAR INFARCTION | 0/1296 (0%) | 2/1308 (0.2%) | ||
CEREBRAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CEREBROVASCULAR ACCIDENT | 5/1296 (0.4%) | 14/1308 (1.1%) | ||
CERVICAL MYELOPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
CERVICOBRACHIAL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
COMPLICATED MIGRAINE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CONVULSION | 0/1296 (0%) | 2/1308 (0.2%) | ||
CUBITAL TUNNEL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
DEPRESSED LEVEL OF CONSCIOUSNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIZZINESS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
EMBOLIC CEREBRAL INFARCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ENCEPHALOPATHY | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
EPILEPSY | 0/1296 (0%) | 1/1308 (0.1%) | ||
GRAND MAL CONVULSION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
HAEMORRHAGE INTRACRANIAL | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HEADACHE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ISCHAEMIC STROKE | 0/1296 (0%) | 4/1308 (0.3%) | ||
METABOLIC ENCEPHALOPATHY | 2/1296 (0.2%) | 0/1308 (0%) | ||
MIGRAINE | 1/1296 (0.1%) | 0/1308 (0%) | ||
MULTIPLE SCLEROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PARTIAL SEIZURES | 0/1296 (0%) | 1/1308 (0.1%) | ||
PRESYNCOPE | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
RADICULOPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
SCIATICA | 1/1296 (0.1%) | 0/1308 (0%) | ||
SENSORY LOSS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUBARACHNOID HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
SYNCOPE | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
TRANSIENT ISCHAEMIC ATTACK | 5/1296 (0.4%) | 2/1308 (0.2%) | ||
TYPICAL AURA WITHOUT HEADACHE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ULNAR TUNNEL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
Pregnancy, puerperium and perinatal conditions | ||||
ABORTION SPONTANEOUS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Psychiatric disorders | ||||
ALCOHOL WITHDRAWAL SYNDROME | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANXIETY | 0/1296 (0%) | 2/1308 (0.2%) | ||
COMPLETED SUICIDE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CONFUSIONAL STATE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CONVERSION DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
DELIRIUM | 1/1296 (0.1%) | 0/1308 (0%) | ||
DEPRESSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEPRESSION SUICIDAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
INTENTIONAL SELF-INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
MENTAL STATUS CHANGES | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
POST-TRAUMATIC AMNESTIC DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SOMATOFORM DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUICIDAL IDEATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
SUICIDE ATTEMPT | 0/1296 (0%) | 1/1308 (0.1%) | ||
Renal and urinary disorders | ||||
CALCULUS URETERIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
CYSTITIS HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSURIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
HAEMATURIA | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
HYDRONEPHROSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
NEPHROLITHIASIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
OBSTRUCTIVE UROPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
RENAL ARTERY STENOSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
RENAL FAILURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
RENAL FAILURE ACUTE | 9/1296 (0.7%) | 9/1308 (0.7%) | ||
RENAL FAILURE CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
RENAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY FISTULA | 1/1296 (0.1%) | 0/1308 (0%) | ||
URINARY INCONTINENCE | 0/1296 (0%) | 2/1308 (0.2%) | ||
URINARY RETENTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
Reproductive system and breast disorders | ||||
BENIGN PROSTATIC HYPERPLASIA | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
EPIDIDYMITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
ERECTILE DYSFUNCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
UTERINE POLYP | 1/1296 (0.1%) | 0/1308 (0%) | ||
VAGINAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
VAGINAL PROLAPSE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE PULMONARY OEDEMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ACUTE RESPIRATORY FAILURE | 6/1296 (0.5%) | 5/1308 (0.4%) | ||
ASTHMA | 2/1296 (0.2%) | 0/1308 (0%) | ||
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 7/1296 (0.5%) | 9/1308 (0.7%) | ||
DIAPHRAGMATIC PARALYSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSPNOEA | 10/1296 (0.8%) | 12/1308 (0.9%) | ||
DYSPNOEA EXERTIONAL | 6/1296 (0.5%) | 4/1308 (0.3%) | ||
EPISTAXIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPOXIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
INTERSTITIAL LUNG DISEASE | 1/1296 (0.1%) | 0/1308 (0%) | ||
PLEURAL EFFUSION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PLEURITIC PAIN | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PNEUMONIA ASPIRATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
PNEUMOTHORAX | 2/1296 (0.2%) | 0/1308 (0%) | ||
PULMONARY EMBOLISM | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
PULMONARY FIBROSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PULMONARY HYPERTENSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
PULMONARY OEDEMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
RESPIRATORY DISTRESS | 2/1296 (0.2%) | 0/1308 (0%) | ||
RESPIRATORY FAILURE | 6/1296 (0.5%) | 2/1308 (0.2%) | ||
SLEEP APNOEA SYNDROME | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
Skin and subcutaneous tissue disorders | ||||
ANGIOEDEMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
DRY GANGRENE | 0/1296 (0%) | 1/1308 (0.1%) | ||
PRECANCEROUS SKIN LESION | 1/1296 (0.1%) | 0/1308 (0%) | ||
RASH | 0/1296 (0%) | 1/1308 (0.1%) | ||
SCAR PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
Surgical and medical procedures | ||||
HIP ARTHROPLASTY | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYSTERECTOMY | 1/1296 (0.1%) | 0/1308 (0%) | ||
PERCUTANEOUS CORONARY INTERVENTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
SPINAL FUSION SURGERY | 0/1296 (0%) | 1/1308 (0.1%) | ||
SURGERY | 0/1296 (0%) | 1/1308 (0.1%) | ||
Vascular disorders | ||||
ACCELERATED HYPERTENSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
ANEURYSM | 0/1296 (0%) | 1/1308 (0.1%) | ||
AORTIC ANEURYSM | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
AORTIC DISSECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
AORTIC STENOSIS | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
ARTERIAL DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
ARTERIAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIAL OCCLUSIVE DISEASE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ARTERIAL THROMBOSIS LIMB | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIOSCLEROSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEEP VEIN THROMBOSIS | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
EMBOLISM ARTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEMORAL ARTERIAL STENOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEMORAL ARTERY ANEURYSM | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
FEMORAL ARTERY OCCLUSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HAEMATOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPERTENSION | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
HYPERTENSIVE CRISIS | 4/1296 (0.3%) | 7/1308 (0.5%) | ||
HYPERTENSIVE EMERGENCY | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
HYPOTENSION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
INTERMITTENT CLAUDICATION | 5/1296 (0.4%) | 2/1308 (0.2%) | ||
MALIGNANT HYPERTENSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ORTHOSTATIC HYPOTENSION | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 2/1296 (0.2%) | 12/1308 (0.9%) | ||
PERIPHERAL VASCULAR DISORDER | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
VENOUS THROMBOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1110/1296 (85.6%) | 1097/1308 (83.9%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 16/1296 (1.2%) | 14/1308 (1.1%) | ||
HAEMORRHAGIC ANAEMIA | 0/1296 (0%) | 3/1308 (0.2%) | ||
HAEMORRHAGIC DIATHESIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
IRON DEFICIENCY ANAEMIA | 5/1296 (0.4%) | 8/1308 (0.6%) | ||
LEUKOCYTOSIS | 0/1296 (0%) | 5/1308 (0.4%) | ||
LYMPHADENOPATHY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
NORMOCHROMIC NORMOCYTIC ANAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PANCYTOPENIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
SPLENIC GRANULOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
THROMBOCYTOPENIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
Cardiac disorders | ||||
ACUTE CORONARY SYNDROME | 8/1296 (0.6%) | 4/1308 (0.3%) | ||
ACUTE LEFT VENTRICULAR FAILURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ACUTE MYOCARDIAL INFARCTION | 22/1296 (1.7%) | 26/1308 (2%) | ||
ANGINA PECTORIS | 281/1296 (21.7%) | 272/1308 (20.8%) | ||
ANGINA UNSTABLE | 36/1296 (2.8%) | 48/1308 (3.7%) | ||
AORTIC VALVE INCOMPETENCE | 1/1296 (0.1%) | 0/1308 (0%) | ||
AORTIC VALVE STENOSIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
ARRHYTHMIA | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
ARTERIOSCLEROSIS CORONARY ARTERY | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
ARTERIOSPASM CORONARY | 0/1296 (0%) | 3/1308 (0.2%) | ||
ATRIAL FIBRILLATION | 41/1296 (3.2%) | 20/1308 (1.5%) | ||
ATRIAL FLUTTER | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
ATRIOVENTRICULAR BLOCK | 0/1296 (0%) | 1/1308 (0.1%) | ||
ATRIOVENTRICULAR BLOCK COMPLETE | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BRADYCARDIA | 12/1296 (0.9%) | 12/1308 (0.9%) | ||
BUNDLE BRANCH BLOCK LEFT | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CARDIAC ANEURYSM | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIAC ARREST | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE | 8/1296 (0.6%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE ACUTE | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE CHRONIC | 5/1296 (0.4%) | 2/1308 (0.2%) | ||
CARDIAC FAILURE CONGESTIVE | 16/1296 (1.2%) | 15/1308 (1.1%) | ||
CARDIAC FLUTTER | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC PERFORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIO-RESPIRATORY ARREST | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIOGENIC SHOCK | 5/1296 (0.4%) | 0/1308 (0%) | ||
CARDIOMYOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIOVASCULAR DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
CHRONOTROPIC INCOMPETENCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONGESTIVE CARDIOMYOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CORONARY ARTERY DISEASE | 30/1296 (2.3%) | 20/1308 (1.5%) | ||
CORONARY ARTERY DISSECTION | 91/1296 (7%) | 63/1308 (4.8%) | ||
CORONARY ARTERY EMBOLISM | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CORONARY ARTERY OCCLUSION | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
CORONARY ARTERY PERFORATION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
CORONARY ARTERY STENOSIS | 7/1296 (0.5%) | 4/1308 (0.3%) | ||
CORONARY ARTERY THROMBOSIS | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
CYANOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIASTOLIC DYSFUNCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
EXTRASYSTOLES | 2/1296 (0.2%) | 0/1308 (0%) | ||
HEART VALVE INCOMPETENCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERTENSIVE HEART DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERTROPHIC CARDIOMYOPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
INTRACARDIAC THROMBUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ISCHAEMIC CARDIOMYOPATHY | 2/1296 (0.2%) | 5/1308 (0.4%) | ||
LEFT VENTRICULAR DYSFUNCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
MITRAL VALVE INCOMPETENCE | 3/1296 (0.2%) | 0/1308 (0%) | ||
MITRAL VALVE PROLAPSE | 1/1296 (0.1%) | 0/1308 (0%) | ||
MYOCARDIAL INFARCTION | 42/1296 (3.2%) | 29/1308 (2.2%) | ||
MYOCARDIAL ISCHAEMIA | 7/1296 (0.5%) | 2/1308 (0.2%) | ||
MYOPERICARDITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
NODAL ARRHYTHMIA | 0/1296 (0%) | 2/1308 (0.2%) | ||
PALPITATIONS | 26/1296 (2%) | 28/1308 (2.1%) | ||
PERICARDIAL EFFUSION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PERICARDITIS | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
PRINZMETAL ANGINA | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
RESTRICTIVE CARDIOMYOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
SICK SINUS SYNDROME | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
SINUS ARREST | 1/1296 (0.1%) | 0/1308 (0%) | ||
SINUS BRADYCARDIA | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
SINUS TACHYCARDIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
SUPRAVENTRICULAR EXTRASYSTOLES | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUPRAVENTRICULAR TACHYCARDIA | 4/1296 (0.3%) | 6/1308 (0.5%) | ||
TACHYARRHYTHMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
TACHYCARDIA | 4/1296 (0.3%) | 4/1308 (0.3%) | ||
VENTRICULAR ARRHYTHMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
VENTRICULAR EXTRASYSTOLES | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
VENTRICULAR FIBRILLATION | 5/1296 (0.4%) | 1/1308 (0.1%) | ||
VENTRICULAR TACHYCARDIA | 13/1296 (1%) | 8/1308 (0.6%) | ||
Congenital, familial and genetic disorders | ||||
ARTERIOVENOUS MALFORMATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONGENITAL ARTERIAL MALFORMATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CORNEAL DYSTROPHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYDROCELE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PHIMOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Ear and labyrinth disorders | ||||
CERUMEN IMPACTION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
DEAFNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DEAFNESS UNILATERAL | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
EAR CONGESTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
EAR HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
EAR PAIN | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
EUSTACHIAN TUBE DYSFUNCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
NEUROSENSORY HYPOACUSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
TINNITUS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
TYMPANIC MEMBRANE PERFORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
VERTIGO | 6/1296 (0.5%) | 10/1308 (0.8%) | ||
VERTIGO POSITIONAL | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
Endocrine disorders | ||||
ADRENAL MASS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARCINOID SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
GOITRE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERPARATHYROIDISM | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERTHYROIDISM | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPOGONADISM | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPOTHYROIDISM | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
SECONDARY HYPOGONADISM | 1/1296 (0.1%) | 0/1308 (0%) | ||
THYROID MASS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Eye disorders | ||||
ABNORMAL SENSATION IN EYE | 0/1296 (0%) | 1/1308 (0.1%) | ||
AMAUROSIS FUGAX | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLINDNESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLINDNESS TRANSIENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATARACT | 6/1296 (0.5%) | 6/1308 (0.5%) | ||
CONJUNCTIVAL HAEMORRHAGE | 0/1296 (0%) | 2/1308 (0.2%) | ||
CONJUNCTIVITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
DIABETIC RETINOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
DIPLOPIA | 0/1296 (0%) | 2/1308 (0.2%) | ||
DRY EYE | 0/1296 (0%) | 1/1308 (0.1%) | ||
EYE HAEMORRHAGE | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
EYE PAIN | 1/1296 (0.1%) | 0/1308 (0%) | ||
GLAUCOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
LACRIMAL DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
MACULAR DEGENERATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
MACULAR FIBROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
MACULAR OEDEMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
OCULAR HYPERAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
RETINAL ARTERY EMBOLISM | 0/1296 (0%) | 1/1308 (0.1%) | ||
RETINAL DETACHMENT | 0/1296 (0%) | 3/1308 (0.2%) | ||
RETINAL DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
RETINAL TEAR | 0/1296 (0%) | 1/1308 (0.1%) | ||
TOLOSA-HUNT SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
VISION BLURRED | 2/1296 (0.2%) | 5/1308 (0.4%) | ||
VISUAL IMPAIRMENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
VITREOUS DETACHMENT | 0/1296 (0%) | 2/1308 (0.2%) | ||
VITREOUS HAEMORRHAGE | 0/1296 (0%) | 2/1308 (0.2%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL DISCOMFORT | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
ABDOMINAL DISTENSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ABDOMINAL HERNIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
ABDOMINAL PAIN | 11/1296 (0.8%) | 17/1308 (1.3%) | ||
ABDOMINAL PAIN LOWER | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
ABDOMINAL PAIN UPPER | 12/1296 (0.9%) | 5/1308 (0.4%) | ||
ANAL FISSURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
APPENDIX DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
ASCITES | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
BARRETT'S OESOPHAGUS | 0/1296 (0%) | 2/1308 (0.2%) | ||
BOWEL MOVEMENT IRREGULARITY | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLITIS | 4/1296 (0.3%) | 1/1308 (0.1%) | ||
COLITIS ISCHAEMIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
COLITIS ULCERATIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLONIC POLYP | 1/1296 (0.1%) | 6/1308 (0.5%) | ||
CONSTIPATION | 5/1296 (0.4%) | 6/1308 (0.5%) | ||
CROHN'S DISEASE | 1/1296 (0.1%) | 0/1308 (0%) | ||
DENTAL CARIES | 3/1296 (0.2%) | 0/1308 (0%) | ||
DIARRHOEA | 16/1296 (1.2%) | 15/1308 (1.1%) | ||
DIVERTICULITIS INTESTINAL HAEMORRHAGIC | 0/1296 (0%) | 3/1308 (0.2%) | ||
DIVERTICULUM | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
DIVERTICULUM INTESTINAL | 2/1296 (0.2%) | 5/1308 (0.4%) | ||
DIVERTICULUM INTESTINAL HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
DUODENAL ULCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
DUODENAL ULCER PERFORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSPEPSIA | 10/1296 (0.8%) | 11/1308 (0.8%) | ||
DYSPHAGIA | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
ENTERITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
ENTEROCOLITIS HAEMORRHAGIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
EPIGASTRIC DISCOMFORT | 0/1296 (0%) | 1/1308 (0.1%) | ||
ERUCTATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
FAECALOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
FAECES DISCOLOURED | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
FLATULENCE | 0/1296 (0%) | 2/1308 (0.2%) | ||
FOOD POISONING | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRIC DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRIC POLYPS | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTRIC ULCER | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
GASTRIC ULCER HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTRITIS | 6/1296 (0.5%) | 8/1308 (0.6%) | ||
GASTRITIS EROSIVE | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
GASTRITIS HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTROINTESTINAL HAEMORRHAGE | 9/1296 (0.7%) | 11/1308 (0.8%) | ||
GASTROINTESTINAL MOTILITY DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL MUCOSAL DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL ULCER HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROOESOPHAGEAL REFLUX DISEASE | 15/1296 (1.2%) | 15/1308 (1.1%) | ||
GINGIVAL BLEEDING | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
GINGIVAL DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
HAEMATEMESIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
HAEMATOCHEZIA | 5/1296 (0.4%) | 3/1308 (0.2%) | ||
HAEMORRHOIDAL HAEMORRHAGE | 0/1296 (0%) | 3/1308 (0.2%) | ||
HAEMORRHOIDS | 1/1296 (0.1%) | 4/1308 (0.3%) | ||
HIATUS HERNIA | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
ILEUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
IMPAIRED GASTRIC EMPTYING | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
INGUINAL HERNIA | 6/1296 (0.5%) | 5/1308 (0.4%) | ||
INTESTINAL MASS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIP HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIP SWELLING | 0/1296 (0%) | 1/1308 (0.1%) | ||
LOWER GASTROINTESTINAL HAEMORRHAGE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
MALLORY-WEISS SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
MELAENA | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
MELANOSIS COLI | 0/1296 (0%) | 1/1308 (0.1%) | ||
MOUTH HAEMORRHAGE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
MOUTH ULCERATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
NAUSEA | 30/1296 (2.3%) | 29/1308 (2.2%) | ||
ODYNOPHAGIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
OESOPHAGEAL HYPOMOTILITY | 1/1296 (0.1%) | 0/1308 (0%) | ||
OESOPHAGEAL SPASM | 0/1296 (0%) | 1/1308 (0.1%) | ||
OESOPHAGEAL STENOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ORAL MUCOSAL DISCOLOURATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
PANCREATITIS | 0/1296 (0%) | 3/1308 (0.2%) | ||
PANCREATITIS ACUTE | 0/1296 (0%) | 3/1308 (0.2%) | ||
PANCREATITIS CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
PARAESTHESIA ORAL | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
POLYP COLORECTAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
PROCTITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PROCTITIS ULCERATIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
RECTAL HAEMORRHAGE | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
RECTAL POLYP | 1/1296 (0.1%) | 0/1308 (0%) | ||
RETROPERITONEAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
SALIVARY GLAND MASS | 1/1296 (0.1%) | 0/1308 (0%) | ||
SMALL INTESTINAL OBSTRUCTION | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
SPIGELIAN HERNIA | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
STOMACH MASS | 1/1296 (0.1%) | 0/1308 (0%) | ||
STOMATITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SWOLLEN TONGUE | 1/1296 (0.1%) | 0/1308 (0%) | ||
TOOTH DISORDER | 0/1296 (0%) | 2/1308 (0.2%) | ||
TOOTH LOSS | 1/1296 (0.1%) | 0/1308 (0%) | ||
TOOTHACHE | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
UMBILICAL HERNIA | 1/1296 (0.1%) | 4/1308 (0.3%) | ||
UPPER GASTROINTESTINAL HAEMORRHAGE | 3/1296 (0.2%) | 0/1308 (0%) | ||
VOLVULUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
VOMITING | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
General disorders | ||||
ADVERSE DRUG REACTION | 80/1296 (6.2%) | 76/1308 (5.8%) | ||
ASTHENIA | 21/1296 (1.6%) | 17/1308 (1.3%) | ||
AXILLARY PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE | 3/1296 (0.2%) | 0/1308 (0%) | ||
CATHETER SITE HAEMATOMA | 26/1296 (2%) | 32/1308 (2.4%) | ||
CATHETER SITE HAEMORRHAGE | 8/1296 (0.6%) | 16/1308 (1.2%) | ||
CATHETER SITE NECROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATHETER SITE PAIN | 9/1296 (0.7%) | 21/1308 (1.6%) | ||
CATHETER SITE RASH | 1/1296 (0.1%) | 0/1308 (0%) | ||
CATHETER SITE RELATED REACTION | 0/1296 (0%) | 3/1308 (0.2%) | ||
CATHETER SITE SWELLING | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
CHEST DISCOMFORT | 46/1296 (3.5%) | 50/1308 (3.8%) | ||
CHEST PAIN | 84/1296 (6.5%) | 90/1308 (6.9%) | ||
COMPLICATION OF DEVICE REMOVAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
CYST | 0/1296 (0%) | 6/1308 (0.5%) | ||
DEATH | 1/1296 (0.1%) | 4/1308 (0.3%) | ||
DEVICE FAILURE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEVICE ISSUE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEVICE LEAD DAMAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
DEVICE MALFUNCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DEVICE OCCLUSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DRUG INTOLERANCE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
EARLY SATIETY | 0/1296 (0%) | 1/1308 (0.1%) | ||
FACIAL PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
FATIGUE | 42/1296 (3.2%) | 41/1308 (3.1%) | ||
FEELING COLD | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEELING HOT | 0/1296 (0%) | 1/1308 (0.1%) | ||
GENERAL PHYSICAL HEALTH DETERIORATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
GENERALISED OEDEMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
GRANULOMA | 2/1296 (0.2%) | 0/1308 (0%) | ||
IMPAIRED HEALING | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
INFLAMMATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
INFLUENZA LIKE ILLNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
INFUSION SITE PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
LOCAL SWELLING | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALAISE | 9/1296 (0.7%) | 9/1308 (0.7%) | ||
MEDICAL DEVICE SITE REACTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
NON-CARDIAC CHEST PAIN | 184/1296 (14.2%) | 225/1308 (17.2%) | ||
OEDEMA | 0/1296 (0%) | 3/1308 (0.2%) | ||
OEDEMA PERIPHERAL | 23/1296 (1.8%) | 17/1308 (1.3%) | ||
PACEMAKER GENERATED ARRHYTHMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PAIN | 1/1296 (0.1%) | 7/1308 (0.5%) | ||
PATIENT-DEVICE INCOMPATIBILITY | 1/1296 (0.1%) | 0/1308 (0%) | ||
PYREXIA | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
SENSATION OF FOREIGN BODY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SPINAL PAIN | 1/1296 (0.1%) | 0/1308 (0%) | ||
SWELLING | 0/1296 (0%) | 1/1308 (0.1%) | ||
THROMBOSIS IN DEVICE | 9/1296 (0.7%) | 6/1308 (0.5%) | ||
ULCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
UNEVALUABLE EVENT | 1/1296 (0.1%) | 0/1308 (0%) | ||
VESSEL PUNCTURE SITE HAEMATOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
VESSEL PUNCTURE SITE THROMBOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Hepatobiliary disorders | ||||
ACUTE HEPATIC FAILURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT OBSTRUCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT STONE | 0/1296 (0%) | 3/1308 (0.2%) | ||
BILIARY DILATATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHOLANGITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
CHOLANGITIS ACUTE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CHOLECYSTITIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
CHOLECYSTITIS ACUTE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CHOLECYSTITIS CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHOLELITHIASIS | 5/1296 (0.4%) | 4/1308 (0.3%) | ||
GALLBLADDER DISORDER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
GRANULOMATOUS LIVER DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC CIRRHOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC CYST | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
HEPATIC FUNCTION ABNORMAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
HEPATIC LESION | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC STEATOSIS | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
ISCHAEMIC HEPATITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
JAUNDICE | 1/1296 (0.1%) | 0/1308 (0%) | ||
Immune system disorders | ||||
ALLERGY TO ARTHROPOD BITE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ALLERGY TO ARTHROPOD STING | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANAPHYLACTIC REACTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CONTRAST MEDIA ALLERGY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DRUG HYPERSENSITIVITY | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
FOOD ALLERGY | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERSENSITIVITY | 0/1296 (0%) | 1/1308 (0.1%) | ||
SARCOIDOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SEASONAL ALLERGY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
Infections and infestations | ||||
ABSCESS LIMB | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ABSCESS NECK | 1/1296 (0.1%) | 0/1308 (0%) | ||
ABSCESS ORAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
ACARODERMATITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ACUTE SINUSITIS | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
APPENDICITIS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
ARTERIOVENOUS GRAFT SITE INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTHRITIS INFECTIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACTERAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
BACTERIAL INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACTERIAL SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
BODY TINEA | 1/1296 (0.1%) | 0/1308 (0%) | ||
BRONCHITIS | 19/1296 (1.5%) | 19/1308 (1.5%) | ||
BRONCHITIS VIRAL | 0/1296 (0%) | 3/1308 (0.2%) | ||
BRONCHOPNEUMONIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
BURSITIS INFECTIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CAMPYLOBACTER INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATHETER SITE ABSCESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATHETER SITE CELLULITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CELLULITIS | 10/1296 (0.8%) | 10/1308 (0.8%) | ||
CHOLECYSTITIS INFECTIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHRONIC SINUSITIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
CLOSTRIDIAL INFECTION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CLOSTRIDIUM COLITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONJUNCTIVITIS BACTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
CYSTITIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
DIABETIC FOOT INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIVERTICULITIS | 12/1296 (0.9%) | 10/1308 (0.8%) | ||
EAR INFECTION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
EMPYEMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
ENDOMETRITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
EPIDEMIC POLYARTHRITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ESCHERICHIA BACTERAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ESCHERICHIA INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ESCHERICHIA SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
ESCHERICHIA URINARY TRACT INFECTION | 0/1296 (0%) | 2/1308 (0.2%) | ||
EXTRADURAL ABSCESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
FURUNCLE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GANGRENE | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTRITIS VIRAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTROENTERITIS | 2/1296 (0.2%) | 8/1308 (0.6%) | ||
GASTROENTERITIS VIRAL | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
GENITAL HERPES | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HELICOBACTER INFECTION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
HERPES SIMPLEX | 0/1296 (0%) | 1/1308 (0.1%) | ||
HERPES ZOSTER | 5/1296 (0.4%) | 7/1308 (0.5%) | ||
IMPETIGO | 0/1296 (0%) | 1/1308 (0.1%) | ||
INFECTED BITES | 2/1296 (0.2%) | 0/1308 (0%) | ||
INFECTED CYST | 0/1296 (0%) | 1/1308 (0.1%) | ||
INFECTIOUS PLEURAL EFFUSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
INFLUENZA | 10/1296 (0.8%) | 16/1308 (1.2%) | ||
INTERTRIGO CANDIDA | 0/1296 (0%) | 1/1308 (0.1%) | ||
KIDNEY INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
LABYRINTHITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
LARYNGITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIVER ABSCESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LOBAR PNEUMONIA | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
LOCALISED INFECTION | 2/1296 (0.2%) | 0/1308 (0%) | ||
LOWER RESPIRATORY TRACT INFECTION | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
LUNG INFECTION PSEUDOMONAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
LYME DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
LYMPH GLAND INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
MYRINGITIS BULLOUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
NASOPHARYNGITIS | 9/1296 (0.7%) | 12/1308 (0.9%) | ||
NECROTISING FASCIITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OESOPHAGEAL CANDIDIASIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
ORAL CANDIDIASIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
ORAL FUNGAL INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
ORCHITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
OSTEOMYELITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OTITIS EXTERNA | 1/1296 (0.1%) | 0/1308 (0%) | ||
OTITIS MEDIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
OTITIS MEDIA ACUTE | 1/1296 (0.1%) | 0/1308 (0%) | ||
OTITIS MEDIA CHRONIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
PELVIC INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
PHARYNGITIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
PHARYNGITIS BACTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
PHARYNGITIS STREPTOCOCCAL | 0/1296 (0%) | 2/1308 (0.2%) | ||
PNEUMONIA | 18/1296 (1.4%) | 21/1308 (1.6%) | ||
PNEUMONIA ESCHERICHIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
POSTOPERATIVE WOUND INFECTION | 2/1296 (0.2%) | 0/1308 (0%) | ||
PYELONEPHRITIS | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
PYELONEPHRITIS ACUTE | 1/1296 (0.1%) | 0/1308 (0%) | ||
RESPIRATORY TRACT INFECTION | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
RESPIRATORY TRACT INFECTION VIRAL | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SCROTAL ABSCESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
SEPSIS | 9/1296 (0.7%) | 5/1308 (0.4%) | ||
SEPTIC SHOCK | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SIALOADENITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SINOBRONCHITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SINUSITIS | 11/1296 (0.8%) | 10/1308 (0.8%) | ||
SINUSITIS BACTERIAL | 2/1296 (0.2%) | 0/1308 (0%) | ||
SKIN INFECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
STAPHYLOCOCCAL ABSCESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
STAPHYLOCOCCAL INFECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
STAPHYLOCOCCAL SEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUBCUTANEOUS ABSCESS | 0/1296 (0%) | 2/1308 (0.2%) | ||
TOOTH ABSCESS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
TOOTH INFECTION | 3/1296 (0.2%) | 5/1308 (0.4%) | ||
TRICHOMONIASIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
UPPER RESPIRATORY TRACT INFECTION | 18/1296 (1.4%) | 20/1308 (1.5%) | ||
UPPER RESPIRATORY TRACT INFECTION BACTERIAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY TRACT INFECTION | 12/1296 (0.9%) | 21/1308 (1.6%) | ||
UROSEPSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
VAGINITIS BACTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
VIRAL INFECTION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
VIRAL LABYRINTHITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
VIRAL UPPER RESPIRATORY TRACT INFECTION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
WOUND INFECTION | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
WOUND INFECTION BACTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
WOUND INFECTION STAPHYLOCOCCAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
Injury, poisoning and procedural complications | ||||
ACCIDENTAL OVERDOSE | 0/1296 (0%) | 2/1308 (0.2%) | ||
ACETABULUM FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANAEMIA POSTOPERATIVE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
ANASTOMOTIC ULCER HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANIMAL BITE | 0/1296 (0%) | 4/1308 (0.3%) | ||
ANKLE FRACTURE | 2/1296 (0.2%) | 5/1308 (0.4%) | ||
ARTHROPOD BITE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
ARTHROPOD STING | 1/1296 (0.1%) | 0/1308 (0%) | ||
AXILLARY NERVE INJURY | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACK INJURY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CARDIAC PROCEDURE COMPLICATION | 7/1296 (0.5%) | 3/1308 (0.2%) | ||
CATHETER SITE HAEMATOMA | 3/1296 (0.2%) | 5/1308 (0.4%) | ||
CERVICAL VERTEBRAL FRACTURE | 2/1296 (0.2%) | 0/1308 (0%) | ||
COMMINUTED FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CONFUSION POSTOPERATIVE | 2/1296 (0.2%) | 0/1308 (0%) | ||
CONTRAST MEDIA ALLERGY | 1/1296 (0.1%) | 0/1308 (0%) | ||
CONTUSION | 15/1296 (1.2%) | 19/1308 (1.5%) | ||
CORNEAL ABRASION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CORONARY ARTERY RESTENOSIS | 33/1296 (2.5%) | 20/1308 (1.5%) | ||
CRANIOCEREBRAL INJURY | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
CYSTITIS RADIATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
DEPRESSION POSTOPERATIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
DRUG ADMINISTRATION ERROR | 0/1296 (0%) | 1/1308 (0.1%) | ||
EAR INJURY | 1/1296 (0.1%) | 0/1308 (0%) | ||
EPICONDYLITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
EXCORIATION | 0/1296 (0%) | 2/1308 (0.2%) | ||
EXPOSURE TO TOXIC AGENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
EYE PENETRATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
FACIAL BONES FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
FALL | 12/1296 (0.9%) | 15/1308 (1.1%) | ||
FEMUR FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
FIBULA FRACTURE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
FOOT FRACTURE | 2/1296 (0.2%) | 6/1308 (0.5%) | ||
FOREARM FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL DISORDER POSTOPERATIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
GASTROINTESTINAL STOMA COMPLICATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
HAND FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEAD INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEAT EXHAUSTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
HIP FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HUMERUS FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
IN-STENT ARTERIAL RESTENOSIS | 2/1296 (0.2%) | 0/1308 (0%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 6/1296 (0.5%) | 9/1308 (0.7%) | ||
INCISION SITE PAIN | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
INCORRECT DOSE ADMINISTERED | 2/1296 (0.2%) | 0/1308 (0%) | ||
INJURY | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
JOINT DISLOCATION | 0/1296 (0%) | 2/1308 (0.2%) | ||
JOINT INJURY | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
LACERATION | 9/1296 (0.7%) | 10/1308 (0.8%) | ||
LIGAMENT RUPTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIGAMENT SPRAIN | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
LIMB INJURY | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
LUMBAR VERTEBRAL FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
MOUTH INJURY | 0/1296 (0%) | 2/1308 (0.2%) | ||
MUSCLE RUPTURE | 2/1296 (0.2%) | 0/1308 (0%) | ||
MUSCLE STRAIN | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
OVERDOSE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PATELLA FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
PELVIC FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
PELVIC ORGAN INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
PERIPROSTHETIC FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
PLAQUE SHIFT | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
POISONING | 0/1296 (0%) | 1/1308 (0.1%) | ||
POISONING DELIBERATE | 0/1296 (0%) | 1/1308 (0.1%) | ||
POST PROCEDURAL COMPLICATION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
POST PROCEDURAL DISCOMFORT | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
POST PROCEDURAL HAEMATOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
POST PROCEDURAL HAEMATURIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
POST PROCEDURAL MYOCARDIAL INFARCTION | 20/1296 (1.5%) | 13/1308 (1%) | ||
POST PROCEDURAL OEDEMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
POST-TRAUMATIC PAIN | 7/1296 (0.5%) | 8/1308 (0.6%) | ||
POSTOPERATIVE FEVER | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
POSTOPERATIVE HERNIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
POSTOPERATIVE ILEUS | 1/1296 (0.1%) | 0/1308 (0%) | ||
POSTOPERATIVE RESPIRATORY DISTRESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PROCEDURAL COMPLICATION | 2/1296 (0.2%) | 0/1308 (0%) | ||
PROCEDURAL DIZZINESS | 2/1296 (0.2%) | 0/1308 (0%) | ||
PROCEDURAL HAEMORRHAGE | 2/1296 (0.2%) | 0/1308 (0%) | ||
PROCEDURAL HEADACHE | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
PROCEDURAL HYPERTENSION | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
PROCEDURAL HYPOTENSION | 10/1296 (0.8%) | 2/1308 (0.2%) | ||
PROCEDURAL NAUSEA | 8/1296 (0.6%) | 6/1308 (0.5%) | ||
PROCEDURAL PAIN | 14/1296 (1.1%) | 14/1308 (1.1%) | ||
PROCEDURAL VOMITING | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
RADIUS FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
RIB FRACTURE | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
ROAD TRAFFIC ACCIDENT | 5/1296 (0.4%) | 4/1308 (0.3%) | ||
SEROMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
SPINAL COMPRESSION FRACTURE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SPINAL FRACTURE | 1/1296 (0.1%) | 0/1308 (0%) | ||
STAB WOUND | 0/1296 (0%) | 1/1308 (0.1%) | ||
SUBDURAL HAEMATOMA | 0/1296 (0%) | 3/1308 (0.2%) | ||
SUTURE RUPTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
TENDON RUPTURE | 2/1296 (0.2%) | 0/1308 (0%) | ||
THERMAL BURN | 2/1296 (0.2%) | 0/1308 (0%) | ||
THORACIC VERTEBRAL FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
TOOTH FRACTURE | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
TRAUMATIC HAEMATOMA | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
TRAUMATIC HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
TRAUMATIC INTRACRANIAL HAEMORRHAGE | 1/1296 (0.1%) | 0/1308 (0%) | ||
TRAUMATIC LUNG INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
UPPER LIMB FRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY RETENTION POSTOPERATIVE | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
VASCULAR GRAFT COMPLICATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
VASCULAR GRAFT OCCLUSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
VASCULAR PSEUDOANEURYSM | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
WOUND COMPLICATION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
WOUND DEHISCENCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
WOUND HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
WRIST FRACTURE | 1/1296 (0.1%) | 5/1308 (0.4%) | ||
Investigations | ||||
ALANINE AMINOTRANSFERASE INCREASED | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ANGIOGRAM | 1/1296 (0.1%) | 0/1308 (0%) | ||
ARTERIAL BRUIT | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIOGRAM CORONARY | 2/1296 (0.2%) | 0/1308 (0%) | ||
ARTERIOGRAM CORONARY ABNORMAL | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
BLOOD CHOLESTEROL DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD CHOLESTEROL INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD CREATINE PHOSPHOKINASE INCREASED | 18/1296 (1.4%) | 19/1308 (1.5%) | ||
BLOOD CREATINE PHOSPHOKINASE MB ABNORMAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLOOD CREATINE PHOSPHOKINASE MB DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD CREATINE PHOSPHOKINASE MB INCREASED | 68/1296 (5.2%) | 59/1308 (4.5%) | ||
BLOOD CREATININE INCREASED | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
BLOOD GLUCOSE DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD GLUCOSE INCREASED | 4/1296 (0.3%) | 4/1308 (0.3%) | ||
BLOOD LACTIC ACID INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD MAGNESIUM DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLOOD POTASSIUM DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD PRESSURE DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLOOD PRESSURE INCREASED | 9/1296 (0.7%) | 2/1308 (0.2%) | ||
BLOOD PRESSURE SYSTOLIC DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD PRESSURE SYSTOLIC INCREASED | 2/1296 (0.2%) | 0/1308 (0%) | ||
BLOOD TESTOSTERONE DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD TRIGLYCERIDES INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD URIC ACID INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLOOD URINE PRESENT | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIAC ENZYMES INCREASED | 149/1296 (11.5%) | 149/1308 (11.4%) | ||
CARDIAC MURMUR | 0/1296 (0%) | 1/1308 (0.1%) | ||
CARDIAC STRESS TEST ABNORMAL | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
CAROTID BRUIT | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATHETERISATION CARDIAC | 1/1296 (0.1%) | 0/1308 (0%) | ||
COMPUTERISED TOMOGRAM THORAX ABNORMAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
EJECTION FRACTION DECREASED | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ELECTROCARDIOGRAM ABNORMAL | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
ELECTROCARDIOGRAM ST SEGMENT ELEVATION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
FEMORAL BRUIT | 1/1296 (0.1%) | 0/1308 (0%) | ||
FIBRIN D DIMER INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
GLYCOSYLATED HAEMOGLOBIN INCREASED | 0/1296 (0%) | 3/1308 (0.2%) | ||
HAEMOGLOBIN DECREASED | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HEART RATE DECREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEART RATE INCREASED | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
HEART RATE IRREGULAR | 0/1296 (0%) | 2/1308 (0.2%) | ||
HEPATIC ENZYME INCREASED | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
INFLUENZA A VIRUS TEST POSITIVE | 0/1296 (0%) | 1/1308 (0.1%) | ||
LEFT VENTRICULAR END-DIASTOLIC PRESSURE INCREASED | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
LIVER FUNCTION TEST ABNORMAL | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
LIVER SCAN ABNORMAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
LOW DENSITY LIPOPROTEIN INCREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
LYMPHOCYTE COUNT INCREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
MEAN CELL VOLUME ABNORMAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
OCCULT BLOOD POSITIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
OESOPHAGOGASTRODUODENOSCOPY ABNORMAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
OXYGEN SATURATION DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
PLATELET COUNT DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
PROSTATIC SPECIFIC ANTIGEN INCREASED | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
STRESS ECHOCARDIOGRAM ABNORMAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
TRANSAMINASES INCREASED | 0/1296 (0%) | 1/1308 (0.1%) | ||
TROPONIN I INCREASED | 8/1296 (0.6%) | 14/1308 (1.1%) | ||
TROPONIN INCREASED | 107/1296 (8.3%) | 86/1308 (6.6%) | ||
TROPONIN T INCREASED | 14/1296 (1.1%) | 12/1308 (0.9%) | ||
ULTRASOUND THYROID ABNORMAL | 0/1296 (0%) | 1/1308 (0.1%) | ||
WEIGHT DECREASED | 0/1296 (0%) | 2/1308 (0.2%) | ||
WEIGHT INCREASED | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
WHITE BLOOD CELL COUNT DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
Metabolism and nutrition disorders | ||||
CARBOHYDRATE INTOLERANCE | 1/1296 (0.1%) | 0/1308 (0%) | ||
DECREASED APPETITE | 2/1296 (0.2%) | 0/1308 (0%) | ||
DEHYDRATION | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
DIABETES MELLITUS | 5/1296 (0.4%) | 6/1308 (0.5%) | ||
DIABETES MELLITUS INADEQUATE CONTROL | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIABETIC KETOACIDOSIS | 1/1296 (0.1%) | 6/1308 (0.5%) | ||
FAILURE TO THRIVE | 1/1296 (0.1%) | 0/1308 (0%) | ||
FLUID OVERLOAD | 1/1296 (0.1%) | 0/1308 (0%) | ||
GLUCOSE TOLERANCE IMPAIRED | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
GOUT | 9/1296 (0.7%) | 2/1308 (0.2%) | ||
HYPERCALCAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPERCHOLESTEROLAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPERGLYCAEMIA | 4/1296 (0.3%) | 3/1308 (0.2%) | ||
HYPERKALAEMIA | 3/1296 (0.2%) | 0/1308 (0%) | ||
HYPERLIPIDAEMIA | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
HYPERTRIGLYCERIDAEMIA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HYPERURICAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPOGLYCAEMIA | 4/1296 (0.3%) | 4/1308 (0.3%) | ||
HYPOKALAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPOMAGNESAEMIA | 0/1296 (0%) | 2/1308 (0.2%) | ||
HYPONATRAEMIA | 0/1296 (0%) | 3/1308 (0.2%) | ||
HYPOVITAMINOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPOVOLAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
IRON DEFICIENCY | 1/1296 (0.1%) | 0/1308 (0%) | ||
KETOACIDOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LACTIC ACIDOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALNUTRITION | 0/1296 (0%) | 1/1308 (0.1%) | ||
METABOLIC ACIDOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OBESITY | 0/1296 (0%) | 1/1308 (0.1%) | ||
TYPE 2 DIABETES MELLITUS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
VITAMIN B12 DEFICIENCY | 1/1296 (0.1%) | 0/1308 (0%) | ||
VITAMIN D DEFICIENCY | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 28/1296 (2.2%) | 21/1308 (1.6%) | ||
ARTHRITIS | 7/1296 (0.5%) | 5/1308 (0.4%) | ||
ARTHROPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
BACK PAIN | 25/1296 (1.9%) | 32/1308 (2.4%) | ||
BONE PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
BURSITIS | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
CERVICAL SPINAL STENOSIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CHONDROMALACIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
CHONDROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
COSTOCHONDRITIS | 0/1296 (0%) | 3/1308 (0.2%) | ||
DUPUYTREN'S CONTRACTURE | 0/1296 (0%) | 1/1308 (0.1%) | ||
EXOSTOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
FLANK PAIN | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
FOOT DEFORMITY | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
GROIN PAIN | 1/1296 (0.1%) | 0/1308 (0%) | ||
INTERVERTEBRAL DISC COMPRESSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
INTERVERTEBRAL DISC DEGENERATION | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
INTERVERTEBRAL DISC PROTRUSION | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
JOINT EFFUSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
JOINT STIFFNESS | 0/1296 (0%) | 2/1308 (0.2%) | ||
JOINT SWELLING | 6/1296 (0.5%) | 4/1308 (0.3%) | ||
LIMB DISCOMFORT | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
LUMBAR SPINAL STENOSIS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
MONARTHRITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
MUSCLE ATROPHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
MUSCLE SPASMS | 9/1296 (0.7%) | 9/1308 (0.7%) | ||
MUSCLE TIGHTNESS | 0/1296 (0%) | 2/1308 (0.2%) | ||
MUSCLE TWITCHING | 1/1296 (0.1%) | 0/1308 (0%) | ||
MUSCULAR WEAKNESS | 7/1296 (0.5%) | 4/1308 (0.3%) | ||
MUSCULOSKELETAL CHEST PAIN | 11/1296 (0.8%) | 12/1308 (0.9%) | ||
MUSCULOSKELETAL DISCOMFORT | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
MUSCULOSKELETAL PAIN | 22/1296 (1.7%) | 20/1308 (1.5%) | ||
MUSCULOSKELETAL STIFFNESS | 0/1296 (0%) | 2/1308 (0.2%) | ||
MYALGIA | 22/1296 (1.7%) | 17/1308 (1.3%) | ||
NECK PAIN | 6/1296 (0.5%) | 6/1308 (0.5%) | ||
NEUROPATHIC ARTHROPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
OSTEOARTHRITIS | 17/1296 (1.3%) | 16/1308 (1.2%) | ||
OSTEOCHONDROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
OSTEOSCLEROSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PAIN IN EXTREMITY | 18/1296 (1.4%) | 32/1308 (2.4%) | ||
PAIN IN JAW | 3/1296 (0.2%) | 0/1308 (0%) | ||
PLANTAR FASCIAL FIBROMATOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
PLANTAR FASCIITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PSORIATIC ARTHROPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
RHABDOMYOLYSIS | 2/1296 (0.2%) | 0/1308 (0%) | ||
RHEUMATOID ARTHRITIS | 0/1296 (0%) | 3/1308 (0.2%) | ||
ROTATOR CUFF SYNDROME | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
SCLERODERMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
SPINAL COLUMN STENOSIS | 0/1296 (0%) | 2/1308 (0.2%) | ||
SPINAL DISORDER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SPINAL OSTEOARTHRITIS | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
SYNOVIAL CYST | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
TENDONITIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
TRIGGER FINGER | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
VERTEBRAL FORAMINAL STENOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
ACUTE PROMYELOCYTIC LEUKAEMIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
B-CELL LYMPHOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
B-CELL LYMPHOMA STAGE I | 0/1296 (0%) | 1/1308 (0.1%) | ||
B-CELL LYMPHOMA STAGE IV | 0/1296 (0%) | 1/1308 (0.1%) | ||
BASAL CELL CARCINOMA | 6/1296 (0.5%) | 5/1308 (0.4%) | ||
BENIGN BREAST NEOPLASM | 1/1296 (0.1%) | 0/1308 (0%) | ||
BENIGN SOFT TISSUE NEOPLASM | 1/1296 (0.1%) | 0/1308 (0%) | ||
BILE DUCT CANCER | 1/1296 (0.1%) | 0/1308 (0%) | ||
BLADDER CANCER | 1/1296 (0.1%) | 0/1308 (0%) | ||
BOWEN'S DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
BREAST CANCER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
BREAST CANCER IN SITU | 1/1296 (0.1%) | 0/1308 (0%) | ||
BREAST CANCER STAGE II | 1/1296 (0.1%) | 0/1308 (0%) | ||
COLON ADENOMA | 3/1296 (0.2%) | 0/1308 (0%) | ||
COLON CANCER | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
ENDOMETRIAL CANCER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ENDOMETRIAL CANCER METASTATIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
FIBROMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
GASTROINTESTINAL STROMAL TUMOUR | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEPATIC NEOPLASM MALIGNANT RECURRENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
INTESTINAL ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
LIPOMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
LUNG ADENOCARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG CANCER METASTATIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV | 0/1296 (0%) | 1/1308 (0.1%) | ||
LUNG NEOPLASM | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
LUNG NEOPLASM MALIGNANT | 4/1296 (0.3%) | 0/1308 (0%) | ||
LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALIGNANT GLIOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALIGNANT MELANOMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
MALIGNANT PLEURAL EFFUSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
MANTLE CELL LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MENINGIOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
METASTASES TO CENTRAL NERVOUS SYSTEM | 1/1296 (0.1%) | 0/1308 (0%) | ||
METASTATIC RENAL CELL CARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
MUELLER'S MIXED TUMOUR | 1/1296 (0.1%) | 0/1308 (0%) | ||
MULTIPLE MYELOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
MYELODYSPLASTIC SYNDROME | 2/1296 (0.2%) | 0/1308 (0%) | ||
NEOPLASM MALIGNANT | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
NEOPLASM SKIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
NEUROENDOCRINE CARCINOMA METASTATIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
NON-HODGKIN'S LYMPHOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
OESOPHAGEAL CARCINOMA | 0/1296 (0%) | 2/1308 (0.2%) | ||
OROPHARYNGEAL CANCER STAGE UNSPECIFIED | 0/1296 (0%) | 1/1308 (0.1%) | ||
OVARIAN CANCER METASTATIC | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
OVARIAN CANCER STAGE III | 1/1296 (0.1%) | 0/1308 (0%) | ||
PANCREATIC CARCINOMA METASTATIC | 0/1296 (0%) | 2/1308 (0.2%) | ||
PANCREATIC NEUROENDOCRINE TUMOUR | 0/1296 (0%) | 1/1308 (0.1%) | ||
PARATHYROID TUMOUR BENIGN | 0/1296 (0%) | 1/1308 (0.1%) | ||
PHAEOCHROMOCYTOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PITUITARY TUMOUR BENIGN | 0/1296 (0%) | 1/1308 (0.1%) | ||
PLASMACYTOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
PROSTATE CANCER | 4/1296 (0.3%) | 5/1308 (0.4%) | ||
RENAL CELL CARCINOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
SALIVARY GLAND CANCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SALIVARY GLAND NEOPLASM | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SEBORRHOEIC KERATOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SKIN CANCER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SMALL CELL LUNG CANCER STAGE UNSPECIFIED | 1/1296 (0.1%) | 0/1308 (0%) | ||
SQUAMOUS CELL CARCINOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
SQUAMOUS CELL CARCINOMA OF SKIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
THYROID NEOPLASM | 0/1296 (0%) | 2/1308 (0.2%) | ||
TRANSITIONAL CELL CARCINOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
URETERIC CANCER RECURRENT | 1/1296 (0.1%) | 0/1308 (0%) | ||
Nervous system disorders | ||||
APHASIA | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
BASAL GANGLIA INFARCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
BASILAR ARTERY STENOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRAIN INJURY | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRAIN MASS | 0/1296 (0%) | 2/1308 (0.2%) | ||
CAROTID ARTERIOSCLEROSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CAROTID ARTERY STENOSIS | 4/1296 (0.3%) | 5/1308 (0.4%) | ||
CARPAL TUNNEL SYNDROME | 7/1296 (0.5%) | 7/1308 (0.5%) | ||
CENTRAL NERVOUS SYSTEM LESION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CEREBELLAR ATROPHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
CEREBELLAR INFARCTION | 0/1296 (0%) | 2/1308 (0.2%) | ||
CEREBRAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
CEREBROVASCULAR ACCIDENT | 5/1296 (0.4%) | 16/1308 (1.2%) | ||
CERVICAL MYELOPATHY | 1/1296 (0.1%) | 0/1308 (0%) | ||
CERVICOBRACHIAL SYNDROME | 3/1296 (0.2%) | 1/1308 (0.1%) | ||
COGNITIVE DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
COMPLICATED MIGRAINE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CONVULSION | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
CUBITAL TUNNEL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
DEMENTIA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEPRESSED LEVEL OF CONSCIOUSNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIABETIC NEUROPATHY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DIZZINESS | 61/1296 (4.7%) | 60/1308 (4.6%) | ||
DIZZINESS EXERTIONAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
DIZZINESS POSTURAL | 14/1296 (1.1%) | 6/1308 (0.5%) | ||
DRUG WITHDRAWAL HEADACHE | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSARTHRIA | 0/1296 (0%) | 3/1308 (0.2%) | ||
DYSGEUSIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
EMBOLIC CEREBRAL INFARCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ENCEPHALOPATHY | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
EPILEPSY | 0/1296 (0%) | 1/1308 (0.1%) | ||
FACIAL PARESIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
GRAND MAL CONVULSION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
HAEMORRHAGE INTRACRANIAL | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HEAD DISCOMFORT | 1/1296 (0.1%) | 0/1308 (0%) | ||
HEAD TITUBATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
HEADACHE | 19/1296 (1.5%) | 22/1308 (1.7%) | ||
HYPERTONIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYPOAESTHESIA | 21/1296 (1.6%) | 13/1308 (1%) | ||
INTERCOSTAL NEURALGIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ISCHAEMIC STROKE | 0/1296 (0%) | 4/1308 (0.3%) | ||
LACUNAR INFARCTION | 2/1296 (0.2%) | 0/1308 (0%) | ||
LETHARGY | 0/1296 (0%) | 2/1308 (0.2%) | ||
LOSS OF CONSCIOUSNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUMBAR RADICULOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
MEMORY IMPAIRMENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
METABOLIC ENCEPHALOPATHY | 2/1296 (0.2%) | 0/1308 (0%) | ||
MIGRAINE | 5/1296 (0.4%) | 3/1308 (0.2%) | ||
MULTIPLE SCLEROSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
NERVE COMPRESSION | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
NEURALGIA | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
NEUROPATHY PERIPHERAL | 3/1296 (0.2%) | 5/1308 (0.4%) | ||
PARAESTHESIA | 26/1296 (2%) | 25/1308 (1.9%) | ||
PARTIAL SEIZURES | 0/1296 (0%) | 1/1308 (0.1%) | ||
PRESYNCOPE | 10/1296 (0.8%) | 7/1308 (0.5%) | ||
RADIAL NERVE COMPRESSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
RADICULOPATHY | 2/1296 (0.2%) | 0/1308 (0%) | ||
RESTLESS LEGS SYNDROME | 2/1296 (0.2%) | 0/1308 (0%) | ||
SCIATICA | 5/1296 (0.4%) | 4/1308 (0.3%) | ||
SENSORY LOSS | 0/1296 (0%) | 1/1308 (0.1%) | ||
SOMNOLENCE | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
SUBARACHNOID HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
SYNCOPE | 14/1296 (1.1%) | 20/1308 (1.5%) | ||
TRANSIENT ISCHAEMIC ATTACK | 6/1296 (0.5%) | 5/1308 (0.4%) | ||
TREMOR | 1/1296 (0.1%) | 0/1308 (0%) | ||
TYPICAL AURA WITHOUT HEADACHE | 1/1296 (0.1%) | 0/1308 (0%) | ||
ULNAR TUNNEL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
VIITH NERVE PARALYSIS | 2/1296 (0.2%) | 0/1308 (0%) | ||
Pregnancy, puerperium and perinatal conditions | ||||
ABORTION SPONTANEOUS | 0/1296 (0%) | 1/1308 (0.1%) | ||
Psychiatric disorders | ||||
ALCOHOL WITHDRAWAL SYNDROME | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANORGASMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
ANXIETY | 18/1296 (1.4%) | 15/1308 (1.1%) | ||
ANXIETY DISORDER DUE TO A GENERAL MEDICAL CONDITION | 1/1296 (0.1%) | 0/1308 (0%) | ||
COMPLETED SUICIDE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CONFUSIONAL STATE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CONVERSION DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
DELIRIUM | 2/1296 (0.2%) | 0/1308 (0%) | ||
DEPRESSION | 5/1296 (0.4%) | 9/1308 (0.7%) | ||
DEPRESSION SUICIDAL | 0/1296 (0%) | 2/1308 (0.2%) | ||
DISORIENTATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
INSOMNIA | 6/1296 (0.5%) | 7/1308 (0.5%) | ||
INTENTIONAL SELF-INJURY | 0/1296 (0%) | 2/1308 (0.2%) | ||
MENTAL STATUS CHANGES | 4/1296 (0.3%) | 4/1308 (0.3%) | ||
PANIC ATTACK | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
PANIC DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
PERSONALITY DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
POST-TRAUMATIC AMNESTIC DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SLEEP DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
SOMATOFORM DISORDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
STRESS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SUICIDAL IDEATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
SUICIDE ATTEMPT | 0/1296 (0%) | 1/1308 (0.1%) | ||
WITHDRAWAL SYNDROME | 0/1296 (0%) | 1/1308 (0.1%) | ||
Renal and urinary disorders | ||||
AZOTAEMIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLADDER NECK OBSTRUCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
BLADDER PROLAPSE | 1/1296 (0.1%) | 0/1308 (0%) | ||
CALCULUS URETERIC | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
CALCULUS URINARY | 0/1296 (0%) | 1/1308 (0.1%) | ||
CYSTITIS HAEMORRHAGIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSURIA | 5/1296 (0.4%) | 1/1308 (0.1%) | ||
HAEMATURIA | 7/1296 (0.5%) | 14/1308 (1.1%) | ||
HYDRONEPHROSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
HYPERTONIC BLADDER | 0/1296 (0%) | 1/1308 (0.1%) | ||
NEPHROLITHIASIS | 9/1296 (0.7%) | 8/1308 (0.6%) | ||
NOCTURIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
OBSTRUCTIVE UROPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
POLLAKIURIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
POLYURIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
RENAL ARTERY STENOSIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
RENAL COLIC | 1/1296 (0.1%) | 0/1308 (0%) | ||
RENAL CYST | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
RENAL FAILURE | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
RENAL FAILURE ACUTE | 14/1296 (1.1%) | 15/1308 (1.1%) | ||
RENAL FAILURE CHRONIC | 0/1296 (0%) | 2/1308 (0.2%) | ||
RENAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
RENAL IMPAIRMENT | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
RENAL MASS | 2/1296 (0.2%) | 0/1308 (0%) | ||
RENAL PAIN | 1/1296 (0.1%) | 0/1308 (0%) | ||
URETHRAL MEATUS STENOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY BLADDER POLYP | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY FISTULA | 1/1296 (0.1%) | 0/1308 (0%) | ||
URINARY HESITATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
URINARY INCONTINENCE | 1/1296 (0.1%) | 3/1308 (0.2%) | ||
URINARY RETENTION | 3/1296 (0.2%) | 2/1308 (0.2%) | ||
URINARY TRACT OBSTRUCTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
URINE FLOW DECREASED | 1/1296 (0.1%) | 0/1308 (0%) | ||
Reproductive system and breast disorders | ||||
ATROPHIC VULVOVAGINITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
BENIGN PROSTATIC HYPERPLASIA | 7/1296 (0.5%) | 4/1308 (0.3%) | ||
BREAST PAIN | 2/1296 (0.2%) | 0/1308 (0%) | ||
CYSTOCELE | 0/1296 (0%) | 1/1308 (0.1%) | ||
EPIDIDYMITIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
ERECTILE DYSFUNCTION | 4/1296 (0.3%) | 1/1308 (0.1%) | ||
GENITAL SWELLING | 0/1296 (0%) | 1/1308 (0.1%) | ||
MENORRHAGIA | 0/1296 (0%) | 1/1308 (0.1%) | ||
PENILE PAIN | 0/1296 (0%) | 2/1308 (0.2%) | ||
PROSTATITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PROSTATOMEGALY | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
SCROTAL CYST | 0/1296 (0%) | 1/1308 (0.1%) | ||
UTERINE POLYP | 1/1296 (0.1%) | 0/1308 (0%) | ||
VAGINAL HAEMATOMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
VAGINAL HAEMORRHAGE | 0/1296 (0%) | 4/1308 (0.3%) | ||
VAGINAL PROLAPSE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE PULMONARY OEDEMA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ACUTE RESPIRATORY FAILURE | 6/1296 (0.5%) | 5/1308 (0.4%) | ||
ASTHMA | 7/1296 (0.5%) | 2/1308 (0.2%) | ||
ATELECTASIS | 3/1296 (0.2%) | 3/1308 (0.2%) | ||
BRONCHITIS CHRONIC | 0/1296 (0%) | 1/1308 (0.1%) | ||
BRONCHOSPASM | 0/1296 (0%) | 1/1308 (0.1%) | ||
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 14/1296 (1.1%) | 14/1308 (1.1%) | ||
COUGH | 17/1296 (1.3%) | 30/1308 (2.3%) | ||
DIAPHRAGMATIC PARALYSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSPNOEA | 137/1296 (10.6%) | 135/1308 (10.3%) | ||
DYSPNOEA AT REST | 1/1296 (0.1%) | 0/1308 (0%) | ||
DYSPNOEA EXERTIONAL | 49/1296 (3.8%) | 57/1308 (4.4%) | ||
EMPHYSEMA | 3/1296 (0.2%) | 0/1308 (0%) | ||
EPISTAXIS | 20/1296 (1.5%) | 12/1308 (0.9%) | ||
HAEMOPTYSIS | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
HYPOXIA | 2/1296 (0.2%) | 0/1308 (0%) | ||
INTERSTITIAL LUNG DISEASE | 1/1296 (0.1%) | 0/1308 (0%) | ||
LUNG DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
NASAL CONGESTION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
NASAL SEPTUM DEVIATION | 1/1296 (0.1%) | 0/1308 (0%) | ||
OBSTRUCTIVE AIRWAYS DISORDER | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
OROPHARYNGEAL DISCOMFORT | 0/1296 (0%) | 1/1308 (0.1%) | ||
OROPHARYNGEAL PAIN | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PHARYNGEAL HYPERTROPHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
PLEURAL EFFUSION | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
PLEURITIC PAIN | 2/1296 (0.2%) | 4/1308 (0.3%) | ||
PNEUMONIA ASPIRATION | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
PNEUMOTHORAX | 2/1296 (0.2%) | 0/1308 (0%) | ||
PRODUCTIVE COUGH | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
PULMONARY CONGESTION | 0/1296 (0%) | 3/1308 (0.2%) | ||
PULMONARY EMBOLISM | 5/1296 (0.4%) | 3/1308 (0.2%) | ||
PULMONARY FIBROSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
PULMONARY HYPERTENSION | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
PULMONARY MASS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PULMONARY OEDEMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
REFLUX LARYNGITIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
RESPIRATORY DISTRESS | 2/1296 (0.2%) | 0/1308 (0%) | ||
RESPIRATORY FAILURE | 6/1296 (0.5%) | 2/1308 (0.2%) | ||
RESTRICTIVE PULMONARY DISEASE | 0/1296 (0%) | 1/1308 (0.1%) | ||
RHINITIS ALLERGIC | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
SINUS CONGESTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
SLEEP APNOEA SYNDROME | 6/1296 (0.5%) | 12/1308 (0.9%) | ||
THROAT IRRITATION | 2/1296 (0.2%) | 0/1308 (0%) | ||
THROAT TIGHTNESS | 1/1296 (0.1%) | 0/1308 (0%) | ||
UPPER RESPIRATORY TRACT CONGESTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
VOCAL CORD POLYP | 0/1296 (0%) | 1/1308 (0.1%) | ||
WHEEZING | 0/1296 (0%) | 2/1308 (0.2%) | ||
Skin and subcutaneous tissue disorders | ||||
ACNE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ACTINIC KERATOSIS | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
ALOPECIA | 1/1296 (0.1%) | 0/1308 (0%) | ||
ANGIOEDEMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
DERMAL CYST | 0/1296 (0%) | 1/1308 (0.1%) | ||
DERMATITIS | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
DERMATITIS CONTACT | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DRUG ERUPTION | 10/1296 (0.8%) | 5/1308 (0.4%) | ||
DRY GANGRENE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ECCHYMOSIS | 1/1296 (0.1%) | 4/1308 (0.3%) | ||
ERYTHEMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HYPERHIDROSIS | 20/1296 (1.5%) | 19/1308 (1.5%) | ||
INCREASED TENDENCY TO BRUISE | 4/1296 (0.3%) | 6/1308 (0.5%) | ||
INGROWING NAIL | 1/1296 (0.1%) | 0/1308 (0%) | ||
LICHEN SCLEROSUS | 0/1296 (0%) | 1/1308 (0.1%) | ||
LIVEDO RETICULARIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
NIGHT SWEATS | 3/1296 (0.2%) | 4/1308 (0.3%) | ||
PETECHIAE | 1/1296 (0.1%) | 0/1308 (0%) | ||
PRECANCEROUS SKIN LESION | 1/1296 (0.1%) | 0/1308 (0%) | ||
PRURITUS | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
PRURITUS ALLERGIC | 0/1296 (0%) | 2/1308 (0.2%) | ||
PSORIASIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
RASH | 12/1296 (0.9%) | 5/1308 (0.4%) | ||
RASH GENERALISED | 0/1296 (0%) | 1/1308 (0.1%) | ||
RASH MACULAR | 1/1296 (0.1%) | 0/1308 (0%) | ||
RASH PRURITIC | 4/1296 (0.3%) | 2/1308 (0.2%) | ||
SCAR PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
SKIN DISCOLOURATION | 0/1296 (0%) | 1/1308 (0.1%) | ||
SKIN FISSURES | 0/1296 (0%) | 1/1308 (0.1%) | ||
SKIN LESION | 2/1296 (0.2%) | 3/1308 (0.2%) | ||
SKIN ULCER | 2/1296 (0.2%) | 0/1308 (0%) | ||
SWELLING FACE | 0/1296 (0%) | 1/1308 (0.1%) | ||
SYSTEMIC LUPUS ERYTHEMATOSUS RASH | 1/1296 (0.1%) | 0/1308 (0%) | ||
URTICARIA | 5/1296 (0.4%) | 2/1308 (0.2%) | ||
Social circumstances | ||||
MENOPAUSE | 1/1296 (0.1%) | 0/1308 (0%) | ||
PHYSICAL ASSAULT | 0/1296 (0%) | 1/1308 (0.1%) | ||
TREATMENT NONCOMPLIANCE | 0/1296 (0%) | 1/1308 (0.1%) | ||
Surgical and medical procedures | ||||
ABSCESS DRAINAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
BAKER'S CYST EXCISION | 1/1296 (0.1%) | 0/1308 (0%) | ||
CARDIAC PACEMAKER BATTERY REPLACEMENT | 0/1296 (0%) | 1/1308 (0.1%) | ||
CATARACT OPERATION | 2/1296 (0.2%) | 0/1308 (0%) | ||
FRACTURE REDUCTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
HIP ARTHROPLASTY | 0/1296 (0%) | 1/1308 (0.1%) | ||
HYSTERECTOMY | 1/1296 (0.1%) | 0/1308 (0%) | ||
MOLE EXCISION | 0/1296 (0%) | 1/1308 (0.1%) | ||
PERCUTANEOUS CORONARY INTERVENTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ROTATOR CUFF REPAIR | 1/1296 (0.1%) | 0/1308 (0%) | ||
SPINAL FUSION SURGERY | 0/1296 (0%) | 1/1308 (0.1%) | ||
SURGERY | 0/1296 (0%) | 1/1308 (0.1%) | ||
Vascular disorders | ||||
ACCELERATED HYPERTENSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
ANEURYSM | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
AORTIC ANEURYSM | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
AORTIC DISSECTION | 0/1296 (0%) | 1/1308 (0.1%) | ||
AORTIC INTRAMURAL HAEMATOMA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
AORTIC STENOSIS | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
ARTERIAL DISORDER | 1/1296 (0.1%) | 0/1308 (0%) | ||
ARTERIAL HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIAL OCCLUSIVE DISEASE | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ARTERIAL SPASM | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
ARTERIAL THROMBOSIS LIMB | 0/1296 (0%) | 1/1308 (0.1%) | ||
ARTERIOSCLEROSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
ARTERIOVENOUS FISTULA | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
DEEP VEIN THROMBOSIS | 3/1296 (0.2%) | 5/1308 (0.4%) | ||
EMBOLISM ARTERIAL | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEMORAL ARTERIAL STENOSIS | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
FEMORAL ARTERY ANEURYSM | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEMORAL ARTERY DISSECTION | 1/1296 (0.1%) | 0/1308 (0%) | ||
FEMORAL ARTERY OCCLUSION | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
HAEMATOMA | 8/1296 (0.6%) | 8/1308 (0.6%) | ||
HAEMORRHAGE | 0/1296 (0%) | 1/1308 (0.1%) | ||
HOT FLUSH | 2/1296 (0.2%) | 1/1308 (0.1%) | ||
HYPERTENSION | 42/1296 (3.2%) | 51/1308 (3.9%) | ||
HYPERTENSIVE CRISIS | 11/1296 (0.8%) | 8/1308 (0.6%) | ||
HYPERTENSIVE EMERGENCY | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
HYPOTENSION | 28/1296 (2.2%) | 23/1308 (1.8%) | ||
ILIAC ARTERY OCCLUSION | 0/1296 (0%) | 1/1308 (0.1%) | ||
INTERMITTENT CLAUDICATION | 5/1296 (0.4%) | 5/1308 (0.4%) | ||
INTRA-ABDOMINAL HAEMATOMA | 0/1296 (0%) | 1/1308 (0.1%) | ||
ISCHAEMIC LIMB PAIN | 0/1296 (0%) | 1/1308 (0.1%) | ||
MACROANGIOPATHY | 0/1296 (0%) | 1/1308 (0.1%) | ||
MALIGNANT HYPERTENSION | 1/1296 (0.1%) | 0/1308 (0%) | ||
ORTHOSTATIC HYPOTENSION | 6/1296 (0.5%) | 6/1308 (0.5%) | ||
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 4/1296 (0.3%) | 13/1308 (1%) | ||
PERIPHERAL COLDNESS | 0/1296 (0%) | 1/1308 (0.1%) | ||
PERIPHERAL VASCULAR DISORDER | 1/1296 (0.1%) | 2/1308 (0.2%) | ||
REPERFUSION INJURY | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
THROMBOPHLEBITIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
THROMBOPHLEBITIS SUPERFICIAL | 0/1296 (0%) | 2/1308 (0.2%) | ||
THROMBOSIS | 1/1296 (0.1%) | 0/1308 (0%) | ||
VARICOSE VEIN | 1/1296 (0.1%) | 0/1308 (0%) | ||
VASOSPASM | 1/1296 (0.1%) | 1/1308 (0.1%) | ||
VENOUS INSUFFICIENCY | 2/1296 (0.2%) | 2/1308 (0.2%) | ||
VENOUS THROMBOSIS | 0/1296 (0%) | 1/1308 (0.1%) | ||
VENOUS THROMBOSIS LIMB | 1/1296 (0.1%) | 0/1308 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Siok Hwee Tan |
---|---|
Organization | Abbott Vascular |
Phone | 408-571-9281 |
siokwee.tan@abbott.com |
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