ABSORB-III: ABSORB III Randomized Controlled Trial (RCT)
Study Details
Study Description
Brief Summary
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and 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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
ABSORB III RCT:
- Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
B. Powered Secondary Objectives:
- Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.
The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.
The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.
- Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.
All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Absorb BVS Subjects receiving Absorb BVS |
Device: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm
Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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.
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 |
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
Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
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 Cardiac Death/TV-MI/ID-TLR (TLF) [1 year]
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Secondary Outcome Measures
- Number of Participants With Powered Secondary Endpoint: Angina [1 year]
Angina is defined as the first adverse event resulting in the site diagnosis of angina.
- Number of Participants With Powered Secondary Endpoint: All Revascularization [1 year]
This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
- Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) [1 year]
This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
- Acute Success- Device Success (Lesion Level Analysis) [On day 0 (the day of procedure)]
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.
- Acute Success: Procedural Success (Subject Level Analysis) [On day 0 (the day of procedure)]
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) [0 to 5 years]
DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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. 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.
- Number of Participants With All Myocardial Infarction (MI) [0 to 5 years]
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
- Number of Participants With All Target Lesion Revascularization (TLR) [0 to 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 (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
- Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) [0 to 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.
- Number of Participants With All Revascularization [0 to 5 years]
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
- Number of Death/All MI [0 to 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 Cardiac Death/All MI [0 to 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 Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 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 Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [0 to 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 With Target Vessel Failure (TVF) [0 to 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 Death/All MI/All Revascularization (DMR) [0 to 5 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
- Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition) [≤ 1 Day]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition) [0 to 30 Days]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Number of Participants With Subacute Stent/Scaffold Thrombosis [>1 to 30 Days]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) [31 to 365 Days]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition) [366 to 393 Days]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Number of Participants With Cumulative Stent/Scaffold Thrombosis [0 to 1853 Days]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Pre-Procedure Minimum Lumen Diameter (MLD) [< or = 1 day]
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
- Pre-Procedure Percent Diameter Stenosis (%DS) [< or = 1 day]
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
- Post-Procedure In-Segment Minimum Lumen Diameter (MLD) [≤ 7 days post index procedure]
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
- Post-Procedure In-Segment Percent Diameter Stenosis (%DS) [≤ 7 days post index procedure]
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
- Post-Procedure In-Device Minimum Lumen Diameter (MLD) [≤ 7 days post index procedure]
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
- Post-Procedure In-Device Percent Diameter Stenosis (%DS) [≤ 7 days post index procedure]
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
- Post-Procedure In-Device Acute Gain [≤ 7 days post index procedure]
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
- Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS) [From Post procedure to 3 Years]
Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
- Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA) [3 Years]
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
- Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal [3 Years]
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
- Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area [3 Years]
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
- Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area [3 Years]
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
- Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts [3 Years]
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Other Outcome Measures
- Patient Reported Outcomes (PRO): Overall Health Status [Baseline]
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
- Patient Reported Outcomes (PRO): Overall Health Status [1 month]
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
- Patient Reported Outcomes (PRO): Overall Health Status [12 months]
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
- Patient Reported Outcomes (PRO): Anxiety [Baseline]
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
- Patient Reported Outcomes (PRO): Anxiety [1 month]
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
- Patient Reported Outcomes (PRO): Anxiety [12 months]
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
- Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [Baseline]
Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
- Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [1 month]
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
- Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [12 months]
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
- Patient Reported Outcomes (PRO): Dyspnea Severity [Baseline]
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
- Patient Reported Outcomes (PRO): Dyspnea Severity [1 month]
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
- Patient Reported Outcomes (PRO): Dyspnea Severity [12 months]
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
- Landmark Analysis on TLF and Components [3-4 years]
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-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 (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-4 years]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-5 years]
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Eligibility Criteria
Criteria
General Inclusion Criteria:
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Subject must be at least 18 years of age.
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Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
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Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
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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 up to 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 1 year following the index procedure.
Angiographic Inclusion Criteria:
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One or two de novo target lesions:
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If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
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If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
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The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
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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 TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
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Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
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Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
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For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.
General Exclusion Criteria:
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Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
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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.
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Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
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Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
-
Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
-
Subject has a cardiac arrhythmia as 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 ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) 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 24 hours and 30 days before the index procedure if successful and uncomplicated.
-
Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral 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 or any other 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 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 gastro-intestinal 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 life expectancy < 5 years for any non-cardiac cause 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 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).
-
Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
-
Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.
-
TIMI Grade-3 flow (per visual estimation).
-
No angiographic complications (e.g. distal embolization, side branch closure).
-
No dissections NHLBI grade D-F.
-
No chest pain lasting > 5 minutes.
-
No ST depression or elevation lasting > 5 minutes.
-
Lesion is located in left main.
-
Aorto-ostial RCA lesion (within 3 mm of the ostium).
-
Lesion located within 3 mm of the origin of the LAD or 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 IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
-
Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
-
Lesion or vessel involves a myocardial bridge.
-
Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
-
Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated 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 | Baptist Medical Center Princeton | Birmingham | Alabama | United States | 35211 |
2 | University of Alabama Hospital | Birmingham | Alabama | United States | 35233 |
3 | Thomas Hospital | Fairhope | Alabama | United States | 36532 |
4 | Baptist Medical Center South | Montgomery | Alabama | United States | 36117 |
5 | Chandler Regional Medical Center | Gilbert | Arizona | United States | 85297 |
6 | Banner Heart Hospital | Mesa | Arizona | United States | 85206 |
7 | Banner Good Samaritan Medical Center | Phoenix | Arizona | United States | 85006 |
8 | Scottsdale Healthcare | Scottsdale | Arizona | United States | 85260 |
9 | Arkansas Heart Hospital | Little Rock | Arkansas | United States | 72211 |
10 | John Muir Medical Center - Concord Campus | Concord | California | United States | 94520 |
11 | Washington Hospital | Fremont | California | United States | 94538 |
12 | Scripps Green Hospital | La Jolla | California | United States | 92037 |
13 | Scripps Memorial Hospital | La Jolla | California | United States | 92037 |
14 | Good Samaritan Hospital | Los Angeles | California | United States | 90017 |
15 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90043 |
16 | Sutter Central Valley Hospitals dba Memorial Medical Center | Modesto | California | United States | 95355 |
17 | Mercy General Hospital | Sacramento | California | United States | 95816 |
18 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
19 | Sutter Medical Center | Sacramento | California | United States | 95819 |
20 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
21 | Santa Barbara Cottage Hospital | Santa Barbara | California | United States | 93105 |
22 | Stanford Hospital and Clinics | Stanford | California | United States | 94305 |
23 | Little Company Of Mary Hospital | Torrance | California | United States | 90503 |
24 | Torrance Memorial Medical Center | Torrance | California | United States | 90505 |
25 | UCH-Memorial Health Systems | Colorado Springs | Colorado | United States | 80909 |
26 | Medical Center of the Rockies | Fort Collins | Colorado | United States | 80538 |
27 | Yale-New Haven Hospital | New Haven | Connecticut | United States | 06520 |
28 | St. Vincent's Medical Center | Stamford | Connecticut | United States | 06905 |
29 | Christiana Care Health Services | Newark | Delaware | United States | 19718 |
30 | Brandon Regional Hospital | Brandon | Florida | United States | 33511 |
31 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
32 | Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
33 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
34 | St. Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
35 | Baptist Medical Center - Downtown | Jacksonville | Florida | United States | 32207 |
36 | University of Florida UF Health | Jacksonville | Florida | United States | 32209 |
37 | University of Miami Hospital | Miami | Florida | United States | 33136 |
38 | Baptist Hospital of Miami | Miami | Florida | United States | 33176 |
39 | MediQuest Research Group Inc at Munroe Regional Medical Center | Ocala | Florida | United States | 34471 |
40 | Florida Hospital | Orlando | Florida | United States | 32803 |
41 | Palm Beach Gardens Medical Center | Palm Beach Gardens | Florida | United States | 33410 |
42 | Bay County Health Systems | Panama City | Florida | United States | 32401 |
43 | Baptist Hospital | Pensacola | Florida | United States | 32501 |
44 | Tallahassee Memorial Hospital | Tallahassee | Florida | United States | 32308 |
45 | Tampa General Hospital | Tampa | Florida | United States | 33609 |
46 | Florida Hospital Pepin Heart Institute | Tampa | Florida | United States | 33613 |
47 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
48 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
49 | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | United States | 30342 |
50 | University Hospital | Augusta | Georgia | United States | 30901 |
51 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
52 | Wellstar Kennestone Hospital | Marietta | Georgia | United States | 30060 |
53 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
54 | Advocate Christ Medical Center | Oak Lawn | Illinois | United States | 60453 |
55 | Saint Francis Medical Center | Peoria | Illinois | United States | 61614 |
56 | St. John's Hospital | Springfield | Illinois | United States | 62701 |
57 | Elkhart General Healthcare | Elkhart | Indiana | United States | 46514 |
58 | Indiana University Health Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
59 | Franciscan St. Francis Health | Indianapolis | Indiana | United States | 46237 |
60 | St. Vincent Heart Center of Indiana | Indianapolis | Indiana | United States | 46290 |
61 | Genesis Medical Center | Davenport | Iowa | United States | 52803 |
62 | Mercy Medical | West Des Moines | Iowa | United States | 50266 |
63 | The University of Kansas Hospital and Medical Center | Kansas City | Kansas | United States | 66106 |
64 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
65 | University of Kentucky Medical Center | Lexington | Kentucky | United States | 40536 |
66 | Jewish Hospital | Louisville | Kentucky | United States | 40202 |
67 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
68 | Maine Medical Center | Portland | Maine | United States | 04102 |
69 | MedStar Washington Hospital Center | Hyattsville | Maryland | United States | 20782 |
70 | Union Memorial Hospital | Hyattsville | Maryland | United States | 20782 |
71 | Peninsula Regional Medical Center | Salisbury | Maryland | United States | 21804 |
72 | Washington Adventist Hospital | Takoma Park | Maryland | United States | 20912 |
73 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
74 | Boston University Medical Center | Boston | Massachusetts | United States | 02118 |
75 | St. Elizabeth's Medical Center of Boston | Brighton | Massachusetts | United States | 02135 |
76 | UMass Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
77 | Bay Regional Medical Center | Bay City | Michigan | United States | 48708 |
78 | Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48124 |
79 | Harper University Hospital | Detroit | Michigan | United States | 48201 |
80 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
81 | St. John Hospital & Medical Center | Detroit | Michigan | United States | 48236 |
82 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49048 |
83 | Sparrow Hospital | Lansing | Michigan | United States | 48910 |
84 | Northern Michigan Hospital | Petoskey | Michigan | United States | 49770 |
85 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48703 |
86 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
87 | St. Joseph Mercy Hospital | Ypsilanti | Michigan | United States | 48197 |
88 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
89 | North Memorial Medical Center | Robbinsdale | Minnesota | United States | 55422 |
90 | North Mississippi Medical Center Cardiology Associates Research, LLC | Tupelo | Mississippi | United States | 38801 |
91 | Boone Hospital Center | Columbia | Missouri | United States | 65201 |
92 | Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
93 | St. Anthony's Medical Center | Saint Louis | Missouri | United States | 63129 |
94 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65807 |
95 | St. Patrick Hospital | Missoula | Montana | United States | 59802 |
96 | Nebraska Heart Hospital | Lincoln | Nebraska | United States | 68526 |
97 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
98 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
99 | Cooper University Hospital | Haddon Heights | New Jersey | United States | 08035 |
100 | Our Lady of Lourdes Medical Center | Haddon Heights | New Jersey | United States | 08035 |
101 | Morristown Medical Center | Morristown | New Jersey | United States | 07962 |
102 | Jersey Shore University Medical Center | Neptune | New Jersey | United States | 07753 |
103 | St. Joseph's Regional Medical Center | Paterson | New Jersey | United States | 07503 |
104 | The Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
105 | Presbyterian Hospital | Albuquerque | New Mexico | United States | 87106 |
106 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
107 | St. Joseph's Hospital Health Center | Liverpool | New York | United States | 13088 |
108 | Long Island Jewish Medical Center | Manhasset | New York | United States | 11030 |
109 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
110 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
111 | Columbia University Medical Center | New York | New York | United States | 10032 |
112 | New York Presbyterian Hospital-Cornell University | New York | New York | United States | 10065 |
113 | Lennox Hill Hospital, | New York | New York | United States | 10075 |
114 | Rochester General Hospital | Rochester | New York | United States | 14621 |
115 | Strong Memorial Hospital | Rochester | New York | United States | 14627 |
116 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
117 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
118 | Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
119 | Duke University Medical Center | Durham | North Carolina | United States | 27110 |
120 | Rex Hospital | Raleigh | North Carolina | United States | 27607 |
121 | WakeMed | Raleigh | North Carolina | United States | 27610 |
122 | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
123 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
124 | Aultman Hospital | Canton | Ohio | United States | 44710 |
125 | University Hospital | Cincinnati | Ohio | United States | 45206 |
126 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
127 | Tri-Health Good Samaritan Hospital | Cincinnati | Ohio | United States | 45220 |
128 | Bethesda North Hospital | Cincinnati | Ohio | United States | 45242 |
129 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
130 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
131 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
132 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
133 | EMH Healthcare | Elyria | Ohio | United States | 44035 |
134 | Cleveland Cln Fairview Hospital | Fairview Park | Ohio | United States | 44126 |
135 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
136 | The Toledo Hospital | Toledo | Ohio | United States | 43606 |
137 | Mercy St. Vincent's Medical Center | Toledo | Ohio | United States | 43608 |
138 | Genesis-Good Samaritan Hospital | Zanesville | Ohio | United States | 43701 |
139 | Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
140 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73120 |
141 | Hillcrest Medical Center | Tulsa | Oklahoma | United States | 74104 |
142 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
143 | PeaceHealth Sacred Heart Medical Center | Springfield | Oregon | United States | 97477 |
144 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
145 | Holy Spirit Hospital | Camp Hill | Pennsylvania | United States | 17011 |
146 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
147 | Doylestown Hospital | Doylestown | Pennsylvania | United States | 18901 |
148 | UPMC Hamot | Erie | Pennsylvania | United States | 16550 |
149 | St. Mary Medical Center | Langhorne | Pennsylvania | United States | 19047 |
150 | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
151 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
152 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
153 | UPMC Presbyterian | Pittsburgh | Pennsylvania | United States | 15213 |
154 | UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | United States | 15219 |
155 | Pinnacle Health at Harrisburg Hospital | Wormleysburg | Pennsylvania | United States | 17043 |
156 | St. Joseph Medical Center | Wyomissing | Pennsylvania | United States | 19610 |
157 | York Hospital | York | Pennsylvania | United States | 17405 |
158 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
159 | The Miriam Hospital | Providence | Rhode Island | United States | 02906 |
160 | AnMed Health | Anderson | South Carolina | United States | 29621 |
161 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
162 | Sisters of Charity Providence Hospital | Columbia | South Carolina | United States | 29204 |
163 | Greenville Memorial Hospital of the Greenville Health System | Greenville | South Carolina | United States | 29605 |
164 | St. Francis Health System | Greenville | South Carolina | United States | 29607 |
165 | Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57104 |
166 | Memorial Hospital | Chattanooga | Tennessee | United States | 37404 |
167 | Wellmont Holston Valley Medical Center | Kingsport | Tennessee | United States | 37660 |
168 | Turkey Creek Medical Center | Knoxville | Tennessee | United States | 37934 |
169 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
170 | Northwest Texas Healthcare System | Amarillo | Texas | United States | 79106 |
171 | Seton Medical Center Austin | Austin | Texas | United States | 78705 |
172 | Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | United States | 75204 |
173 | St. Luke's Episcopal Hospital | Houston | Texas | United States | 77030 |
174 | The Methodist Hospital Research Institute | Houston | Texas | United States | 77030 |
175 | The Heart Hospital Baylor Plano | Plano | Texas | United States | 75093 |
176 | Methodist Texsan Hospital | San Antonio | Texas | United States | 78201 |
177 | East Texas Medical Center | Tyler | Texas | United States | 75701 |
178 | Trinity Mother Frances Hospital Regional Healthcare Center | Tyler | Texas | United States | 75701 |
179 | InterMountain Medical Center | Murray | Utah | United States | 84107 |
180 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
181 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042 |
182 | Mary Washington Hospital | Fredericksburg | Virginia | United States | 22401 |
183 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
184 | Carilion Roanoke Memorial Hospital | Roanoke | Virginia | United States | 24014 |
185 | Winchester Medical Center | Winchester | Virginia | United States | 22601 |
186 | St. Joseph Hospital | Bellingham | Washington | United States | 98225 |
187 | Providence Regional Medical Center Everett | Everett | Washington | United States | 98201 |
188 | Swedish Medical Center | Seattle | Washington | United States | 98122 |
189 | St. Mary's Medical Center | Huntington | West Virginia | United States | 25701 |
190 | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
191 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
192 | St. Vincent's Hospital Melbourne | Fitzroy | Victoria | Australia | 3065 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH
- Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH
- Study Chair: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
- Study Director: Jennifer McMeans Jones, Abbott Medical Devices
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10-392
Study Results
Participant Flow
Recruitment Details | The first Lead-In subject (Lead-In Group ) was registered on Dec 28, 2012. A total of 2008 patients (Primary Analysis Group) were randomized into Absorb BVS arm (n = 1322) and Xience arm (n = 686) at 193 study sites between March 22, 2013 & April 3,2014 and the last 5 year follow-up visit was on May 31, 2019. |
---|---|
Pre-assignment Detail | Of total 13,789 eligible population,11,781 patients were excluded due to, Not meeting general eligibility criteria only (n=567); Not meeting angiographic eligibility criteria only (n=10,690); Not meeting both 1 and 2 (n=64); Other reasons (n=460). |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Period Title: Overall Study | ||
STARTED | 1322 | 686 |
COMPLETED | 1059 | 555 |
NOT COMPLETED | 263 | 131 |
Baseline Characteristics
Arm/Group Title | Absorb BVS | XIENCE | Total |
---|---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. | Total of all reporting groups |
Overall Participants | 1322 | 686 | 2008 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.5
(10.6)
|
63.6
(10.3)
|
63.5
(10.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
388
29.3%
|
205
29.9%
|
593
29.5%
|
Male |
934
70.7%
|
481
70.1%
|
1415
70.5%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Hispanic or Latino |
50
3.8%
|
23
3.4%
|
73
3.6%
|
Not Hispanic or Latino |
1250
94.6%
|
652
95%
|
1902
94.7%
|
Unknown or not reported |
22
1.7%
|
11
1.6%
|
33
1.6%
|
American Indian or Alaska Native |
8
0.6%
|
2
0.3%
|
10
0.5%
|
Asian |
20
1.5%
|
13
1.9%
|
33
1.6%
|
Native Hawaiian or Other Pacific Islander |
8
0.6%
|
1
0.1%
|
9
0.4%
|
Black or African American |
70
5.3%
|
34
5%
|
104
5.2%
|
White |
1152
87.1%
|
606
88.3%
|
1758
87.5%
|
Region of Enrollment (Count of Participants) | |||
United States |
1318
99.7%
|
683
99.6%
|
2001
99.7%
|
Australia |
4
0.3%
|
3
0.4%
|
7
0.3%
|
Hypertension Requiring Medication (Count of Participants) | |||
Count of Participants [Participants] |
1071
81%
|
553
80.6%
|
1624
80.9%
|
Dyslipidemia Requiring Medication (Count of Participants) | |||
Count of Participants [Participants] |
1009
76.3%
|
533
77.7%
|
1542
76.8%
|
Prior Coronary Intervention (Count of Participants) | |||
Count of Participants [Participants] |
512
38.7%
|
260
37.9%
|
772
38.4%
|
Stable Angina (Count of Participants) | |||
Count of Participants [Participants] |
757
57.3%
|
417
60.8%
|
1174
58.5%
|
Outcome Measures
Title | Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
---|---|
Description | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
Intent-To-Treat Population set (ITT). 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1313 | 677 |
Count of Participants [Participants] |
102
7.7%
|
41
6%
|
Title | Number of Participants With Powered Secondary Endpoint: Angina |
---|---|
Description | Angina is defined as the first adverse event resulting in the site diagnosis of angina. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1303 | 678 |
Count of Participants [Participants] |
238
18%
|
125
18.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9256 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Number of Participants With Powered Secondary Endpoint: All Revascularization |
---|---|
Description | This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively). |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1313 | 677 |
Count of Participants [Participants] |
120
9.1%
|
55
8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5040 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) |
---|---|
Description | This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
For ID-TVR, Fisher's exact test is used for superiority testing based on the ITT population. This analysis will include ~2000 subjects. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1313 | 677 |
Count of Participants [Participants] |
66
5%
|
25
3.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.2126 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | 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 | On day 0 (the day of procedure) |
Outcome Measure Data
Analysis Population Description |
---|
Intent-To-Treat Population set (ITT). 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1311 | 678 |
Measure Target Lesions | 1355 | 704 |
Number [Percentage of lesions] |
94.3
|
99.3
|
Title | 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 | On day 0 (the day of procedure) |
Outcome Measure Data
Analysis Population Description |
---|
Intent-To-Treat Population set (ITT). 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1311 | 678 |
Count of Participants [Participants] |
1240
93.8%
|
652
95%
|
Title | Number of Death (Cardiac, Vascular, Non-cardiovascular) |
---|---|
Description | DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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. 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. |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
85
6.4%
|
44
6.4%
|
Title | Number of Participants With All Myocardial Infarction (MI) |
---|---|
Description | Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI) |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
159
12%
|
69
10.1%
|
Title | Number of Participants With All 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 (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
118
8.9%
|
51
7.4%
|
Title | Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (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. |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
108
8.2%
|
40
5.8%
|
Title | Number of Participants With All Revascularization |
---|---|
Description | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
255
19.3%
|
114
16.6%
|
Title | Number of 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 | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
230
17.4%
|
101
14.7%
|
Title | Number of Cardiac 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 | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
185
14%
|
81
11.8%
|
Title | Number of 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 | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
220
16.6%
|
98
14.3%
|
Title | Number of 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 | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
245
18.5%
|
113
16.5%
|
Title | Number of Participants With 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 | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
290
21.9%
|
128
18.7%
|
Title | Number of Death/All MI/All Revascularization (DMR) |
---|---|
Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
Time Frame | 0 to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1187 | 612 |
Count of Participants [Participants] |
378
28.6%
|
168
24.5%
|
Title | Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | ≤ 1 Day |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1319 | 686 |
Definite/Probable |
3
0.2%
|
4
0.6%
|
Definite |
3
0.2%
|
4
0.6%
|
Probable |
0
0%
|
0
0%
|
Title | Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 0 to 30 Days |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1314 | 686 |
Definite/Probable |
14
1.1%
|
5
0.7%
|
Definite |
12
0.9%
|
5
0.7%
|
Probable |
2
0.2%
|
0
0%
|
Title | Number of Participants With Subacute Stent/Scaffold Thrombosis |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | >1 to 30 Days |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1314 | 686 |
Definite/Probable |
12
0.9%
|
1
0.1%
|
Definite |
10
0.8%
|
1
0.1%
|
Probable |
2
0.2%
|
0
0%
|
Title | Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 31 to 365 Days |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1289 | 672 |
Definite/Probable |
6
0.5%
|
0
0%
|
Definite |
6
0.5%
|
0
0%
|
Probable |
0
0%
|
0
0%
|
Title | Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 366 to 393 Days |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1289 | 672 |
Definite/Probable |
0
0%
|
0
0%
|
Definite |
0
0%
|
0
0%
|
Probable |
0
0%
|
0
0%
|
Title | Number of Participants With Cumulative Stent/Scaffold Thrombosis |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 0 to 1853 Days |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1072 | 558 |
Definite/Probable |
32
2.4%
|
7
1%
|
Definite |
30
2.3%
|
7
1%
|
Probable |
2
0.2%
|
0
0%
|
Title | Pre-Procedure Minimum Lumen Diameter (MLD) |
---|---|
Description | Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. |
Time Frame | < or = 1 day |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1380 | 708 |
Mean (Standard Deviation) [Millimeter] |
0.92
(0.37)
|
0.90
(0.34)
|
Title | Pre-Procedure Percent Diameter Stenosis (%DS) |
---|---|
Description | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
Time Frame | < or = 1 day |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1380 | 708 |
Mean (Standard Deviation) [Percent Diameter stenosis] |
65.25
(12.48)
|
65.90
(11.66)
|
Title | Post-Procedure In-Segment Minimum Lumen Diameter (MLD) |
---|---|
Description | Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. |
Time Frame | ≤ 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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1374 | 706 |
Mean (Standard Deviation) [Millimeter] |
2.15
(0.41)
|
2.14
(0.43)
|
Title | Post-Procedure In-Segment Percent Diameter Stenosis (%DS) |
---|---|
Description | Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. |
Time Frame | ≤ 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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1374 | 706 |
Mean (Standard Deviation) [Percent Diameter stenosis] |
20.04
(7.94)
|
19.82
(8.20)
|
Title | Post-Procedure In-Device Minimum Lumen Diameter (MLD) |
---|---|
Description | Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold |
Time Frame | ≤ 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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1373 | 706 |
Mean (Standard Deviation) [Millimeter] |
2.37
(0.40)
|
2.49
(0.40)
|
Title | Post-Procedure In-Device Percent Diameter Stenosis (%DS) |
---|---|
Description | Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
Time Frame | ≤ 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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1369 | 702 |
Mean (Standard Deviation) [Percent Diameter stenosis] |
11.62
(8.77)
|
6.41
(8.91)
|
Title | Post-Procedure In-Device Acute Gain |
---|---|
Description | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). |
Time Frame | ≤ 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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1322 | 686 |
Measure Target Lesions | 1372 | 706 |
Mean (Standard Deviation) [mm] |
1.45
(0.45)
|
1.59
(0.44)
|
Title | Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS) |
---|---|
Description | Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT. |
Time Frame | From Post procedure to 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 188 | 93 |
Measure Lesions | 119 | 65 |
Mean (Standard Deviation) [mm^2] |
-0.30
(1.32)
|
-0.60
(0.91)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Absorb BVS, XIENCE |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0665 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA) |
---|---|
Description | All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions |
Time Frame | 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 33 | 16 |
Measure Leisions | 21 | 10 |
Mean (Standard Deviation) [mm^2] |
1.12
(0.48)
|
1.19
(0.61)
|
Title | Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal |
---|---|
Description | All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions |
Time Frame | 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 33 | 16 |
Measure Leisions | 33 | 16 |
Post-procedure |
6.89
(1.98)
|
7.25
(1.51)
|
3 Years |
7.70
(2.54)
|
7.24
(1.90)
|
Title | Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area |
---|---|
Description | All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions |
Time Frame | 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 33 | 16 |
Measure Leisions | 33 | 16 |
Post-procedure |
7.99
(2.12)
|
7.50
(1.46)
|
3 Years |
6.67
(2.36)
|
6.06
(1.73)
|
Title | Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area |
---|---|
Description | All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions |
Time Frame | 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 33 | 16 |
Measure Leisions | 33 | 16 |
Post-procedure |
6.47
(1.82)
|
6.07
(1.46)
|
3 Years |
4.95
(1.78)
|
4.54
(1.40)
|
Title | Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts |
---|---|
Description | All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions |
Time Frame | 3 Years |
Outcome Measure Data
Analysis Population Description |
---|
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 33 | 16 |
Measure Leisions | 33 | 16 |
Post-procedure |
7.42
(5.49)
|
7.64
(6.26)
|
3 Years |
0.32
(0.99)
|
0.07
(0.22)
|
Title | Patient Reported Outcomes (PRO): Overall Health Status |
---|---|
Description | Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1 |
Time Frame | Baseline |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1249 | 651 |
Mean (Standard Deviation) [score on a scale] |
0.77
(0.2)
|
0.77
(0.20)
|
Title | Patient Reported Outcomes (PRO): Overall Health Status |
---|---|
Description | Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1 |
Time Frame | 1 month |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1231 | 647 |
Mean (Standard Deviation) [score on a scale] |
0.85
(0.18)
|
0.85
(0.18)
|
Title | Patient Reported Outcomes (PRO): Overall Health Status |
---|---|
Description | Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1 |
Time Frame | 12 months |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1087 | 567 |
Mean (Standard Deviation) [score on a scale] |
0.83
(0.20)
|
0.83
(0.19)
|
Title | Patient Reported Outcomes (PRO): Anxiety |
---|---|
Description | Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales |
Time Frame | Baseline |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1009 | 530 |
Mean (Standard Deviation) [score on a scale] |
5.92
(5.86)
|
6.34
(6.07)
|
Title | Patient Reported Outcomes (PRO): Anxiety |
---|---|
Description | Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales |
Time Frame | 1 month |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1067 | 556 |
Mean (Standard Deviation) [score on a scale] |
3.39
(4.64)
|
3.33
(4.61)
|
Title | Patient Reported Outcomes (PRO): Anxiety |
---|---|
Description | Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales |
Time Frame | 12 months |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 911 | 482 |
Mean (Standard Deviation) [score on a scale] |
3.92
(4.99)
|
4.04
(5.08)
|
Title | Patient Reported Outcomes (PRO): Disease-Specific Quality of Life |
---|---|
Description | Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). |
Time Frame | Baseline |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1195 | 617 |
Mean (Standard Deviation) [score on a scale] |
67.67
(20.20)
|
67.11
(19.17)
|
Title | Patient Reported Outcomes (PRO): Disease-Specific Quality of Life |
---|---|
Description | Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). |
Time Frame | 1 month |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1131 | 589 |
Mean (Standard Deviation) [score on a scale] |
87.10
(14.27)
|
86.98
(14.16)
|
Title | Patient Reported Outcomes (PRO): Disease-Specific Quality of Life |
---|---|
Description | Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). |
Time Frame | 12 months |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1014 | 514 |
Mean (Standard Deviation) [score on a scale] |
87.05
(13.91)
|
86.42
(14.45)
|
Title | Patient Reported Outcomes (PRO): Dyspnea Severity |
---|---|
Description | Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales |
Time Frame | Baseline |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1242 | 651 |
Mean (Standard Deviation) [score on a scale] |
1.66
(1.48)
|
1.65
(1.46)
|
Title | Patient Reported Outcomes (PRO): Dyspnea Severity |
---|---|
Description | Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales |
Time Frame | 1 month |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1220 | 636 |
Mean (Standard Deviation) [score on a scale] |
0.81
(1.24)
|
0.88
(1.29)
|
Title | Patient Reported Outcomes (PRO): Dyspnea Severity |
---|---|
Description | Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales |
Time Frame | 12 months |
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. The analysis excludes subjects who are truly lost to follow-up. |
Arm/Group Title | Absorb BVS | XIENCE |
---|---|---|
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1080 | 568 |
Mean (Standard Deviation) [score on a scale] |
0.94
(1.26)
|
0.99
(1.30)
|
Title | Landmark Analysis on TLF and Components |
---|---|
Description | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 3-4 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1202 | 610 |
Count of Participants [Participants] |
38
2.9%
|
16
2.3%
|
Title | Landmark Analysis on TLF and Components |
---|---|
Description | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Time Frame | 3-5 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT set. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1108 | 580 |
Count of Participants [Participants] |
60
4.5%
|
38
5.5%
|
Title | Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 3-4 years |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1180 | 607 |
Definite/Probable |
1
0.1%
|
1
0.1%
|
Definite |
1
0.1%
|
1
0.1%
|
Probable |
0
0%
|
0
0%
|
Title | Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) |
---|---|
Description | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
Time Frame | 3-5 years |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. 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 BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. |
Measure Participants | 1059 | 556 |
Definite/Probable |
1
0.1%
|
2
0.3%
|
Definite |
1
0.1%
|
2
0.3%
|
Probable |
0
0%
|
0
0%
|
Adverse Events
Time Frame | 5 years | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Absorb BVS | XIENCE | ||
Arm/Group Description | Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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. 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. | Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition 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 Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition 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. | ||
All Cause Mortality |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 85/1322 (6.4%) | 44/686 (6.4%) | ||
Serious Adverse Events |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 801/1322 (60.6%) | 398/686 (58%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 7/1322 (0.5%) | 7/686 (1%) | ||
ANAEMIA OF CHRONIC DISEASE | 0/1322 (0%) | 1/686 (0.1%) | ||
COAGULOPATHY | 0/1322 (0%) | 2/686 (0.3%) | ||
FEBRILE NEUTROPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMORRHAGIC ANAEMIA | 2/1322 (0.2%) | 3/686 (0.4%) | ||
HEPARIN-INDUCED THROMBOCYTOPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
IRON DEFICIENCY ANEMIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LEUKOCYTOSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
LYMPHADENOPATHY | 2/1322 (0.2%) | 0/686 (0%) | ||
MICROCYTIC ANAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
NORMOCHROMIC NORMOCYTIC ANAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
THROMBOCYTOPENIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
Cardiac disorders | ||||
ACUTE CORONARY SYNDROME | 6/1322 (0.5%) | 5/686 (0.7%) | ||
ACUTE LEFT VENTRICULAR FAILURE | 0/1322 (0%) | 1/686 (0.1%) | ||
ACUTE MYOCARDIAL INFARCTION | 49/1322 (3.7%) | 21/686 (3.1%) | ||
ANGINA PECTORIS | 161/1322 (12.2%) | 87/686 (12.7%) | ||
ANGINA UNSTABLE | 68/1322 (5.1%) | 28/686 (4.1%) | ||
AORTIC VALVE DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
AORTIC VALVE STENOSIS | 6/1322 (0.5%) | 2/686 (0.3%) | ||
ARRHYTHMIA | 1/1322 (0.1%) | 2/686 (0.3%) | ||
ARTERIOSCLEROSIS CORONARY ARTERY | 2/1322 (0.2%) | 0/686 (0%) | ||
ARTERIOSPASM CORONARY | 1/1322 (0.1%) | 0/686 (0%) | ||
ATRIAL FIBRILLATION | 52/1322 (3.9%) | 21/686 (3.1%) | ||
ATRIAL FLUTTER | 6/1322 (0.5%) | 2/686 (0.3%) | ||
ATRIAL TACHYCARDIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ATRIOVENTRICULAR BLOCK | 3/1322 (0.2%) | 0/686 (0%) | ||
ATRIOVENTRICULAR BLOCK COMPLETE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ATRIOVENTRICULAR BLOCK SECOND DEGREE | 4/1322 (0.3%) | 0/686 (0%) | ||
BRADYCARDIA | 9/1322 (0.7%) | 2/686 (0.3%) | ||
BUNDLE BRANCH BLOCK | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC ARREST | 10/1322 (0.8%) | 6/686 (0.9%) | ||
CARDIAC FAILURE | 8/1322 (0.6%) | 4/686 (0.6%) | ||
CARDIAC FAILURE ACUTE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
CARDIAC FAILURE CHRONIC | 2/1322 (0.2%) | 3/686 (0.4%) | ||
CARDIAC FAILURE CONGESTIVE | 32/1322 (2.4%) | 25/686 (3.6%) | ||
CARDIAC TAMPONADE | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIAC VALVE DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
CARDIO-RESPIRATORY ARREST | 2/1322 (0.2%) | 1/686 (0.1%) | ||
CARDIOGENIC SHOCK | 1/1322 (0.1%) | 3/686 (0.4%) | ||
CARDIOMYOPATHY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CARDIORENAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
CHRONIC LEFT VENTRICULAR FAILURE | 1/1322 (0.1%) | 0/686 (0%) | ||
CONDUCTION DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
CONGESTIVE CARDIOMYOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
CORONARY ARTERY DISEASE | 38/1322 (2.9%) | 24/686 (3.5%) | ||
CORONARY ARTERY DISSECTION | 22/1322 (1.7%) | 12/686 (1.7%) | ||
CORONARY ARTERY EMBOLISM | 2/1322 (0.2%) | 2/686 (0.3%) | ||
CORONARY ARTERY OCCLUSION | 4/1322 (0.3%) | 2/686 (0.3%) | ||
CORONARY ARTERY PERFORATION | 5/1322 (0.4%) | 3/686 (0.4%) | ||
CORONARY ARTERY STENOSIS | 20/1322 (1.5%) | 13/686 (1.9%) | ||
CORONARY OSTIAL STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
DRESSLER'S SYNDROME | 0/1322 (0%) | 2/686 (0.3%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 4/1322 (0.3%) | 5/686 (0.7%) | ||
INTRACARDIAC THROMBUS | 1/1322 (0.1%) | 0/686 (0%) | ||
ISCHAEMIC CARDIOMYOPATHY | 3/1322 (0.2%) | 1/686 (0.1%) | ||
LEFT VENTRICULAR DYSFUNCTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MITRAL VALVE INCOMPETENCE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
MYOCARDIAL INFARCTION | 52/1322 (3.9%) | 23/686 (3.4%) | ||
MYOCARDIAL ISCHAEMIA | 3/1322 (0.2%) | 0/686 (0%) | ||
PALPITATIONS | 1/1322 (0.1%) | 0/686 (0%) | ||
PERICARDIAL EFFUSION | 5/1322 (0.4%) | 1/686 (0.1%) | ||
PERICARDITIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PRINZMETAL ANGINA | 2/1322 (0.2%) | 0/686 (0%) | ||
SICK SINUS SYNDROME | 6/1322 (0.5%) | 3/686 (0.4%) | ||
SINUS ARRHYTHMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
SINUS BRADYCARDIA | 1/1322 (0.1%) | 0/686 (0%) | ||
SUPRAVENTRICULAR TACHYCARDIA | 5/1322 (0.4%) | 2/686 (0.3%) | ||
TACHYCARDIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
TORSADE DE POINTES | 1/1322 (0.1%) | 0/686 (0%) | ||
VENTRICULAR ARRHYTHMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
VENTRICULAR EXTRASYSTOLES | 3/1322 (0.2%) | 0/686 (0%) | ||
VENTRICULAR FIBRILLATION | 5/1322 (0.4%) | 0/686 (0%) | ||
VENTRICULAR TACHYCARDIA | 8/1322 (0.6%) | 3/686 (0.4%) | ||
Congenital, familial and genetic disorders | ||||
CYSTIC LYMPHANGIOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PULMONARY ARTERIOVENOUS FISTULA | 0/1322 (0%) | 1/686 (0.1%) | ||
Ear and labyrinth disorders | ||||
VERTIGO | 5/1322 (0.4%) | 1/686 (0.1%) | ||
Eye disorders | ||||
AMAUROSIS FUGAX | 1/1322 (0.1%) | 0/686 (0%) | ||
CATARACT | 0/1322 (0%) | 3/686 (0.4%) | ||
CATARACT NUCLEAR | 1/1322 (0.1%) | 0/686 (0%) | ||
DIPLOPIA | 1/1322 (0.1%) | 0/686 (0%) | ||
GLAUCOMA | 2/1322 (0.2%) | 0/686 (0%) | ||
MACULAR OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PAPILLOEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
POSTERIOR CAPSULE OPACIFICATION | 1/1322 (0.1%) | 0/686 (0%) | ||
RETINAL DETACHMENT | 1/1322 (0.1%) | 1/686 (0.1%) | ||
RETINAL HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
VISION BLURRED | 1/1322 (0.1%) | 0/686 (0%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL HERNIA | 3/1322 (0.2%) | 3/686 (0.4%) | ||
ABDOMINAL HERNIA OBSTRUCTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
ABDOMINAL PAIN | 3/1322 (0.2%) | 3/686 (0.4%) | ||
ABDOMINAL PAIN UPPER | 2/1322 (0.2%) | 3/686 (0.4%) | ||
ABDOMINAL WALL HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ALCOHOLIC PANCREATITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
COELIAC ARTERY STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
COLITIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
COLITIS ISCHAEMIC | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CONSTIPATION | 2/1322 (0.2%) | 0/686 (0%) | ||
CROHN'S DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
DENTAL CARIES | 1/1322 (0.1%) | 0/686 (0%) | ||
DIABETIC GASTROPARESIS | 1/1322 (0.1%) | 0/686 (0%) | ||
DIARRHOEA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
DIVERTICULUM | 0/1322 (0%) | 1/686 (0.1%) | ||
DIVERTICULUM INTESTINAL HAEMORRHAGIC | 2/1322 (0.2%) | 1/686 (0.1%) | ||
DUODENAL ULCER | 1/1322 (0.1%) | 0/686 (0%) | ||
DUODENAL ULCER HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
DYSPHAGIA | 5/1322 (0.4%) | 1/686 (0.1%) | ||
ENTEROVESICAL FISTULA | 1/1322 (0.1%) | 0/686 (0%) | ||
FAECALOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTRIC HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTRIC ULCER | 2/1322 (0.2%) | 2/686 (0.3%) | ||
GASTRIC ULCER HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTRITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTROINTESTINAL ANGIODYSPLASIA | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTROINTESTINAL HAEMORRHAGE | 13/1322 (1%) | 13/686 (1.9%) | ||
GASTROINTESTINAL ULCER HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
GASTROOESOPHAGEAL REFLUX DISEASE | 5/1322 (0.4%) | 0/686 (0%) | ||
HAEMATEMESIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HAEMATOCHEZIA | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMORRHOIDAL HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
HIATUS HERNIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ILEUS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
IMPAIRED GASTRIC EMPTYING | 3/1322 (0.2%) | 1/686 (0.1%) | ||
INGUINAL HERNIA | 2/1322 (0.2%) | 3/686 (0.4%) | ||
INTESTINAL MASS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
INTESTINAL OBSTRUCTION | 0/1322 (0%) | 2/686 (0.3%) | ||
IRRITABLE BOWEL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
LARGE INTESTINE PERFORATION | 0/1322 (0%) | 1/686 (0.1%) | ||
LOWER GASTROINTESTINAL HAEMORRHAGE | 2/1322 (0.2%) | 2/686 (0.3%) | ||
MALLORY-WEISS SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
MELAENA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MOUTH HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
OESOPHAGEAL ACHALASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
OESOPHAGITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PANCREATIC CYST | 0/1322 (0%) | 1/686 (0.1%) | ||
PANCREATITIS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
PANCREATITIS ACUTE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
RECTAL HAEMORRHAGE | 2/1322 (0.2%) | 2/686 (0.3%) | ||
RETROPERITONEAL HAEMORRHAGE | 3/1322 (0.2%) | 0/686 (0%) | ||
SMALL INTESTINAL OBSTRUCTION | 3/1322 (0.2%) | 6/686 (0.9%) | ||
SMALL INTESTINAL PERFORATION | 0/1322 (0%) | 1/686 (0.1%) | ||
UMBILICAL HERNIA | 2/1322 (0.2%) | 0/686 (0%) | ||
UMBILICAL HERNIA, OBSTRUCTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
UPPER GASTROINTESTINAL HAEMORRHAGE | 3/1322 (0.2%) | 4/686 (0.6%) | ||
General disorders | ||||
ABASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ADVERSE DRUG REACTION | 3/1322 (0.2%) | 1/686 (0.1%) | ||
ASTHENIA | 5/1322 (0.4%) | 0/686 (0%) | ||
CARDIAC DEATH | 1/1322 (0.1%) | 0/686 (0%) | ||
CATHETER SITE HAEMATOMA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CATHETER SITE HAEMORRHAGE | 1/1322 (0.1%) | 2/686 (0.3%) | ||
CATHETER SITE PAIN | 0/1322 (0%) | 2/686 (0.3%) | ||
CHEST DISCOMFORT | 10/1322 (0.8%) | 8/686 (1.2%) | ||
CHEST PAIN | 40/1322 (3%) | 18/686 (2.6%) | ||
DEATH | 10/1322 (0.8%) | 6/686 (0.9%) | ||
DEVICE ELECTRICAL FINDING | 0/1322 (0%) | 1/686 (0.1%) | ||
DEVICE FAILURE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DEVICE MALFUNCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
DEVICE OCCLUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
DROWNING | 1/1322 (0.1%) | 0/686 (0%) | ||
DRUG INTOLERANCE | 1/1322 (0.1%) | 0/686 (0%) | ||
DRUG WITHDRAWAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
HERNIA | 0/1322 (0%) | 1/686 (0.1%) | ||
HERNIA OBSTRUCTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
IMPAIRED HEALING | 0/1322 (0%) | 1/686 (0.1%) | ||
MEDICAL DEVICE SITE REACTION | 1/1322 (0.1%) | 0/686 (0%) | ||
MULTI-ORGAN FAILURE | 1/1322 (0.1%) | 2/686 (0.3%) | ||
NON-CARDIAC CHEST PAIN | 84/1322 (6.4%) | 51/686 (7.4%) | ||
OEDEMA PERIPHERAL | 1/1322 (0.1%) | 0/686 (0%) | ||
PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
PELVIC MASS | 0/1322 (0%) | 2/686 (0.3%) | ||
PYREXIA | 6/1322 (0.5%) | 3/686 (0.4%) | ||
SUDDEN CARDIAC DEATH | 0/1322 (0%) | 1/686 (0.1%) | ||
SURGICAL FAILURE | 1/1322 (0.1%) | 0/686 (0%) | ||
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | 3/1322 (0.2%) | 1/686 (0.1%) | ||
THROMBOSIS IN DEVICE | 9/1322 (0.7%) | 6/686 (0.9%) | ||
Hepatobiliary disorders | ||||
BILE DUCT STONE | 2/1322 (0.2%) | 0/686 (0%) | ||
CHOLANGITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLECYSTITIS | 3/1322 (0.2%) | 2/686 (0.3%) | ||
CHOLECYSTITIS ACUTE | 2/1322 (0.2%) | 4/686 (0.6%) | ||
CHOLECYSTITIS CHRONIC | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLELITHIASIS | 7/1322 (0.5%) | 3/686 (0.4%) | ||
GALLBLADDER DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC LESION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
PORTAL VEIN THROMBOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
Immune system disorders | ||||
ALLERGY TO ARTHROPOD STING | 1/1322 (0.1%) | 1/686 (0.1%) | ||
Infections and infestations | ||||
ABDOMINAL ABSCESS | 0/1322 (0%) | 1/686 (0.1%) | ||
ABSCESS NECK | 1/1322 (0.1%) | 0/686 (0%) | ||
APPENDICITIS | 4/1322 (0.3%) | 2/686 (0.3%) | ||
APPENDICITIS PERFORATED | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTHRITIS BACTERIAL | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTHRITIS INFECTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
BACTERAEMIA | 4/1322 (0.3%) | 0/686 (0%) | ||
BACTERIAL INFECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
BACTERIAL SEPSIS | 0/1322 (0%) | 2/686 (0.3%) | ||
BREAST CELLULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
BRONCHITIS | 10/1322 (0.8%) | 6/686 (0.9%) | ||
BRONCHITIS VIRAL | 1/1322 (0.1%) | 0/686 (0%) | ||
CATHETER SITE ABSCESS | 2/1322 (0.2%) | 0/686 (0%) | ||
CATHETER SITE CELLULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
CATHETER SITE INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
CELLULITIS | 11/1322 (0.8%) | 11/686 (1.6%) | ||
CHOLECYSTITIS INFECTIVE | 0/1322 (0%) | 2/686 (0.3%) | ||
CLOSTRIDIAL INFECTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CLOSTRIDIUM DIFFICILE COLITIS | 2/1322 (0.2%) | 2/686 (0.3%) | ||
CYSTITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
DIABETIC FOOT INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
DIVERTICULITIS | 5/1322 (0.4%) | 3/686 (0.4%) | ||
ENDOCARDITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ENTEROCOCCAL SEPSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
ESCHERICHIA BACTERAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
FUNGAL INFECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
GANGRENE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
GASTROENTERITIS | 6/1322 (0.5%) | 3/686 (0.4%) | ||
GASTROENTERITIS VIRAL | 1/1322 (0.1%) | 2/686 (0.3%) | ||
GENITAL INFECTION FEMALE | 1/1322 (0.1%) | 0/686 (0%) | ||
HERPES ZOSTER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HIV INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
IMPLANT SITE INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
INFECTED DERMAL CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
INFECTED SKIN ULCER | 0/1322 (0%) | 1/686 (0.1%) | ||
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | 1/1322 (0.1%) | 0/686 (0%) | ||
INFLUENZA | 3/1322 (0.2%) | 3/686 (0.4%) | ||
KIDNEY INFECTION | 3/1322 (0.2%) | 0/686 (0%) | ||
LOBAR PNEUMONIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LOCALISED INFECTION | 0/1322 (0%) | 3/686 (0.4%) | ||
LUNG ABSCESS | 0/1322 (0%) | 1/686 (0.1%) | ||
MENINGITIS ASEPTIC | 1/1322 (0.1%) | 0/686 (0%) | ||
METAPNEUMOVIRUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
MYCOBACTERIUM ABSCESSUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORAL FUNGAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORCHITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
OSTEOMYELITIS | 3/1322 (0.2%) | 4/686 (0.6%) | ||
PERITONITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
PERITONSILLAR ABSCESS | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA | 25/1322 (1.9%) | 19/686 (2.8%) | ||
PNEUMONIA ADENOVIRAL | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA BACTERIAL | 2/1322 (0.2%) | 0/686 (0%) | ||
PNEUMONIA NECROTISING | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA PRIMARY ATYPICAL | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA STAPHYLOCOCCAL | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL CELLULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL PNEUMONIA | 1/1322 (0.1%) | 0/686 (0%) | ||
POSTOPERATIVE WOUND INFECTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
RESPIRATORY SYNCYTIAL VIRUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
SEPSIS | 14/1322 (1.1%) | 10/686 (1.5%) | ||
SEPSIS SYNDROME | 2/1322 (0.2%) | 0/686 (0%) | ||
SEPTIC ENCEPHALOPATHY | 0/1322 (0%) | 1/686 (0.1%) | ||
SEPTIC SHOCK | 2/1322 (0.2%) | 1/686 (0.1%) | ||
SPINAL CORD INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
STAPHYLOCOCCAL BACTERAEMIA | 0/1322 (0%) | 2/686 (0.3%) | ||
STAPHYLOCOCCAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
UPPER RESPIRATORY TRACT INFECTION | 2/1322 (0.2%) | 0/686 (0%) | ||
URINARY TRACT INFECTION | 9/1322 (0.7%) | 7/686 (1%) | ||
URINARY TRACT INFECTION BACTERIAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
UROSEPSIS | 3/1322 (0.2%) | 4/686 (0.6%) | ||
VIRAL INFECTION | 2/1322 (0.2%) | 0/686 (0%) | ||
VIRAL LABYRINTHITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
WOUND INFECTION | 1/1322 (0.1%) | 2/686 (0.3%) | ||
WOUND INFECTION BACTERIAL | 0/1322 (0%) | 1/686 (0.1%) | ||
WOUND INFECTION STAPHYLOCOCCAL | 0/1322 (0%) | 1/686 (0.1%) | ||
Injury, poisoning and procedural complications | ||||
ACETABULUM FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
ALCOHOL POISONING | 2/1322 (0.2%) | 2/686 (0.3%) | ||
ANAEMIA POSTOPERATIVE | 3/1322 (0.2%) | 2/686 (0.3%) | ||
ANKLE FRACTURE | 1/1322 (0.1%) | 3/686 (0.4%) | ||
BURNS THIRD DEGREE | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC PROCEDURE COMPLICATION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CEREBRAL HAEMORRHAGE TRAUMATIC | 2/1322 (0.2%) | 0/686 (0%) | ||
CLAVICLE FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
COLON INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
CONCUSSION | 1/1322 (0.1%) | 0/686 (0%) | ||
CONTRAST MEDIA ALLERGY | 0/1322 (0%) | 1/686 (0.1%) | ||
CONTUSION | 2/1322 (0.2%) | 0/686 (0%) | ||
CORONARY ARTERY RESTENOSIS | 51/1322 (3.9%) | 15/686 (2.2%) | ||
CRANIOCEREBRAL INJURY | 3/1322 (0.2%) | 0/686 (0%) | ||
CYSTITIS RADIATION | 1/1322 (0.1%) | 0/686 (0%) | ||
DEEP VEIN THROMBOSIS POSTOPERATIVE | 2/1322 (0.2%) | 0/686 (0%) | ||
EXPOSURE TO TOXIC AGENT | 1/1322 (0.1%) | 0/686 (0%) | ||
FALL | 9/1322 (0.7%) | 7/686 (1%) | ||
FEMORAL NECK FRACTURE | 0/1322 (0%) | 2/686 (0.3%) | ||
FEMUR FRACTURE | 3/1322 (0.2%) | 0/686 (0%) | ||
FOOT FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTROINTESTINAL ANASTOMOTIC LEAK | 0/1322 (0%) | 1/686 (0.1%) | ||
HAND FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
HEAD INJURY | 0/1322 (0%) | 1/686 (0.1%) | ||
HIP FRACTURE | 4/1322 (0.3%) | 2/686 (0.3%) | ||
HUMERUS FRACTURE | 0/1322 (0%) | 2/686 (0.3%) | ||
ILIOTIBIAL BAND SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
IN-STENT ARTERIAL RESTENOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 7/1322 (0.5%) | 5/686 (0.7%) | ||
INCISIONAL HERNIA | 3/1322 (0.2%) | 0/686 (0%) | ||
INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
JOINT DISLOCATION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LACERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
LIGAMENT RUPTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
LIMB INJURY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LIMB TRAUMATIC AMPUTATION | 1/1322 (0.1%) | 0/686 (0%) | ||
MENISCUS LESION | 4/1322 (0.3%) | 1/686 (0.1%) | ||
MULTIPLE FRACTURES | 2/1322 (0.2%) | 0/686 (0%) | ||
MULTIPLE INJURIES | 1/1322 (0.1%) | 0/686 (0%) | ||
MUSCLE RUPTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
PELVIC FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
PLAQUE SHIFT | 1/1322 (0.1%) | 3/686 (0.4%) | ||
POST CONCUSSION SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL HAEMATOMA | 1/1322 (0.1%) | 2/686 (0.3%) | ||
POST PROCEDURAL HAEMORRHAGE | 1/1322 (0.1%) | 2/686 (0.3%) | ||
POST PROCEDURAL MYOCARDIAL INFARCTION | 7/1322 (0.5%) | 5/686 (0.7%) | ||
POST PROCEDURAL STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
POST-TRAUMATIC PAIN | 2/1322 (0.2%) | 0/686 (0%) | ||
POSTOPERATIVE ADHESION | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCEDURAL COMPLICATION | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCEDURAL DIZZINESS | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCEDURAL HEADACHE | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCEDURAL HYPOTENSION | 0/1322 (0%) | 1/686 (0.1%) | ||
PROCEDURAL VOMITING | 1/1322 (0.1%) | 0/686 (0%) | ||
RADIUS FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
RESPIRATORY FUME INHALATION DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
RIB FRACTURE | 2/1322 (0.2%) | 2/686 (0.3%) | ||
ROAD TRAFFIC ACCIDENT | 4/1322 (0.3%) | 0/686 (0%) | ||
SEROMA | 1/1322 (0.1%) | 0/686 (0%) | ||
SKULL FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
SNAKE BITE | 1/1322 (0.1%) | 0/686 (0%) | ||
SPINAL COMPRESSION FRACTURE | 4/1322 (0.3%) | 2/686 (0.3%) | ||
SPINAL FRACTURE | 2/1322 (0.2%) | 0/686 (0%) | ||
SPLENIC RUPTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
STERNAL FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
SUBDURAL HAEMATOMA | 6/1322 (0.5%) | 3/686 (0.4%) | ||
TENDON INJURY | 0/1322 (0%) | 1/686 (0.1%) | ||
TENDON RUPTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
THERMAL BURN | 1/1322 (0.1%) | 0/686 (0%) | ||
THORACIC VERTEBRAL FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
TIBIA FRACTURE | 0/1322 (0%) | 2/686 (0.3%) | ||
TRAUMATIC HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
TRAUMATIC HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
ULNA FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
UPPER LIMB FRACTURE | 2/1322 (0.2%) | 0/686 (0%) | ||
URINARY RETENTION POSTOPERATIVE | 3/1322 (0.2%) | 0/686 (0%) | ||
VASCULAR GRAFT OCCLUSION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
VASCULAR PSEUDOANEURYSM | 7/1322 (0.5%) | 3/686 (0.4%) | ||
WOUND | 1/1322 (0.1%) | 0/686 (0%) | ||
WOUND EVISCERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
WOUND HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
WRIST FRACTURE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
Investigations | ||||
BIOPSY LUNG | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD CREATINE INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD CREATINE PHOSPHOKINASE MB INCREASED | 2/1322 (0.2%) | 0/686 (0%) | ||
BLOOD CREATININE INCREASED | 3/1322 (0.2%) | 0/686 (0%) | ||
BLOOD PRESSURE INCREASED | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BLOOD PRESSURE SYSTOLIC INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIAC ENZYMES INCREASED | 4/1322 (0.3%) | 1/686 (0.1%) | ||
CARDIAC STRESS TEST ABNORMAL | 1/1322 (0.1%) | 2/686 (0.3%) | ||
COMPUTERISED TOMOGRAM ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
COMPUTERISED TOMOGRAM THORAX ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
EJECTION FRACTION DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
ELECTROCARDIOGRAM ST SEGMENT ELEVATION | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMOGLOBIN DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
HEART RATE INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
OXYGEN CONSUMPTION INCREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
TROPONIN INCREASED | 2/1322 (0.2%) | 0/686 (0%) | ||
WHITE BLOOD CELL COUNT INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
Metabolism and nutrition disorders | ||||
DEHYDRATION | 7/1322 (0.5%) | 5/686 (0.7%) | ||
DIABETES MELLITUS | 0/1322 (0%) | 1/686 (0.1%) | ||
DIABETIC KETOACIDOSIS | 5/1322 (0.4%) | 1/686 (0.1%) | ||
FAILURE TO THRIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
FLUID OVERLOAD | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPERGLYCAEMIA | 6/1322 (0.5%) | 2/686 (0.3%) | ||
HYPERKALAEMIA | 0/1322 (0%) | 2/686 (0.3%) | ||
HYPOGLYCAEMIA | 4/1322 (0.3%) | 0/686 (0%) | ||
HYPOKALAEMIA | 3/1322 (0.2%) | 1/686 (0.1%) | ||
HYPOMAGNESAEMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPONATRAEMIA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
HYPOVOLAEMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
LACTIC ACIDOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
METABOLIC ACIDOSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OBESITY | 6/1322 (0.5%) | 3/686 (0.4%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 5/1322 (0.4%) | 3/686 (0.4%) | ||
ARTHRITIS | 4/1322 (0.3%) | 2/686 (0.3%) | ||
BACK PAIN | 3/1322 (0.2%) | 4/686 (0.6%) | ||
BURSITIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CHONDROCALCINOSIS PYROPHOSPHATE | 1/1322 (0.1%) | 0/686 (0%) | ||
COSTOCHONDRITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
DUPUYTREN'S CONTRACTURE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
EXOSTOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
FLANK PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
FRACTURE NONUNION | 1/1322 (0.1%) | 0/686 (0%) | ||
INTERVERTEBRAL DISC PROTRUSION | 9/1322 (0.7%) | 2/686 (0.3%) | ||
JOINT EFFUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
LUMBAR SPINAL STENOSIS | 7/1322 (0.5%) | 2/686 (0.3%) | ||
MUSCULAR WEAKNESS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MUSCULOSKELETAL CHEST PAIN | 4/1322 (0.3%) | 0/686 (0%) | ||
MUSCULOSKELETAL DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
MUSCULOSKELETAL PAIN | 1/1322 (0.1%) | 3/686 (0.4%) | ||
NECK PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
OSTEOARTHRITIS | 26/1322 (2%) | 14/686 (2%) | ||
OSTEOPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
OSTEOPOROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PAIN IN EXTREMITY | 4/1322 (0.3%) | 2/686 (0.3%) | ||
PAIN IN JAW | 1/1322 (0.1%) | 0/686 (0%) | ||
RHABDOMYOLYSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
RHEUMATOID ARTHRITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ROTATOR CUFF SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
SACROILIITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
SPINAL OSTEOARTHRITIS | 3/1322 (0.2%) | 2/686 (0.3%) | ||
SPONDYLITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
SPONDYLOLISTHESIS | 3/1322 (0.2%) | 2/686 (0.3%) | ||
TENDINOUS CONTRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
VERTEBRAL FORAMINAL STENOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
ACUTE MYELOID LEUKAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
ACUTE MYELOID LEUKAEMIA RECURRENT | 1/1322 (0.1%) | 0/686 (0%) | ||
ADENOCARCINOMA | 2/1322 (0.2%) | 1/686 (0.1%) | ||
ADENOCARCINOMA PANCREAS | 1/1322 (0.1%) | 0/686 (0%) | ||
B-CELL LYMPHOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
B-CELL LYMPHOMA STAGE IV | 1/1322 (0.1%) | 0/686 (0%) | ||
BASAL CELL CARCINOMA | 1/1322 (0.1%) | 2/686 (0.3%) | ||
BENIGN OVARIAN TUMOUR | 1/1322 (0.1%) | 0/686 (0%) | ||
BILE DUCT CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
BLADDER CANCER | 3/1322 (0.2%) | 1/686 (0.1%) | ||
BLADDER CANCER RECURRENT | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BLADDER CANCER STAGE IV | 1/1322 (0.1%) | 0/686 (0%) | ||
BLADDER NEOPLASM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BRAIN NEOPLASM | 0/1322 (0%) | 1/686 (0.1%) | ||
BREAST CANCER | 5/1322 (0.4%) | 0/686 (0%) | ||
BREAST CANCER STAGE III | 1/1322 (0.1%) | 0/686 (0%) | ||
CERVIX CARCINOMA | 0/1322 (0%) | 1/686 (0.1%) | ||
CHRONIC LYMPHOCYTIC LEUKAEMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
COLON ADENOMA | 2/1322 (0.2%) | 2/686 (0.3%) | ||
COLON CANCER | 2/1322 (0.2%) | 2/686 (0.3%) | ||
DIFFUSE LARGE B-CELL LYMPHOMA | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTRIC CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
GLIOBLASTOMA | 0/1322 (0%) | 2/686 (0.3%) | ||
HEAD AND NECK CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
HEAD AND NECK CANCER METASTATIC | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC CANCER METASTATIC | 0/1322 (0%) | 1/686 (0.1%) | ||
HEPATIC NEOPLASM MALIGNANT | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPOPHARYNGEAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
LEUKAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
LEUKAEMIA RECURRENT | 1/1322 (0.1%) | 0/686 (0%) | ||
LIP AND/OR ORAL CAVITY CANCER | 0/1322 (0%) | 1/686 (0.1%) | ||
LUNG ADENOCARCINOMA | 3/1322 (0.2%) | 0/686 (0%) | ||
LUNG CANCER METASTATIC | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LUNG NEOPLASM | 2/1322 (0.2%) | 0/686 (0%) | ||
LUNG NEOPLASM MALIGNANT | 6/1322 (0.5%) | 0/686 (0%) | ||
LUNG SQUAMOUS CELL CARCINOMA STAGE III | 1/1322 (0.1%) | 0/686 (0%) | ||
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED | 2/1322 (0.2%) | 0/686 (0%) | ||
LYMPHOMA | 4/1322 (0.3%) | 0/686 (0%) | ||
MALIGNANT MELANOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
MENINGIOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LIVER | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LUNG | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LYMPH NODES | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO SPINE | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTATIC MALIGNANT MELANOMA | 3/1322 (0.2%) | 0/686 (0%) | ||
METASTATIC NEOPLASM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MULTIPLE MYELOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
NEOPLASM MALIGNANT | 2/1322 (0.2%) | 0/686 (0%) | ||
NON-HODGKIN'S LYMPHOMA | 0/1322 (0%) | 1/686 (0.1%) | ||
NON-SMALL CELL LUNG CANCER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OESOPHAGEAL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ORAL NEOPLASM | 0/1322 (0%) | 1/686 (0.1%) | ||
OROPHARYNGEAL CANCER STAGE UNSPECIFIED | 0/1322 (0%) | 1/686 (0.1%) | ||
OVARIAN CANCER METASTATIC | 1/1322 (0.1%) | 0/686 (0%) | ||
OVARIAN EPITHELIAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
PANCREATIC CARCINOMA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PERICARDIAL EFFUSION MALIGNANT | 1/1322 (0.1%) | 0/686 (0%) | ||
PROSTATE CANCER | 11/1322 (0.8%) | 3/686 (0.4%) | ||
RECTAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL CANCER | 0/1322 (0%) | 1/686 (0.1%) | ||
RENAL CELL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL NEOPLASM | 1/1322 (0.1%) | 0/686 (0%) | ||
SINONASAL PAPILLOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
SKIN CANCER | 2/1322 (0.2%) | 0/686 (0%) | ||
SMALL CELL LUNG CANCER LIMITED STAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
SMALL CELL LUNG CANCER STAGE UNSPECIFIED | 1/1322 (0.1%) | 0/686 (0%) | ||
SQUAMOUS CELL CARCINOMA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
SQUAMOUS CELL CARCINOMA OF SKIN | 0/1322 (0%) | 1/686 (0.1%) | ||
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | 1/1322 (0.1%) | 0/686 (0%) | ||
TRANSITIONAL CELL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
URETERIC CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
UTERINE CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
VULVAL CANCER STAGE 0 | 1/1322 (0.1%) | 0/686 (0%) | ||
Nervous system disorders | ||||
ALTERED STATE OF CONSCIOUSNESS | 1/1322 (0.1%) | 0/686 (0%) | ||
APHASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ARACHNOIDITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
AUTONOMIC NERVOUS SYSTEM IMBALANCE | 1/1322 (0.1%) | 0/686 (0%) | ||
CAROTID ARTERY DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
CAROTID ARTERY STENOSIS | 11/1322 (0.8%) | 7/686 (1%) | ||
CARPAL TUNNEL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
CENTRAL NERVOUS SYSTEM LESION | 1/1322 (0.1%) | 0/686 (0%) | ||
CEREBELLAR INFARCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
CEREBRAL HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
CEREBRAL INFARCTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CEREBROVASCULAR ACCIDENT | 19/1322 (1.4%) | 15/686 (2.2%) | ||
CEREBROVASCULAR DISORDER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CERVICOBRACHIAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
COMPLICATED MIGRAINE | 2/1322 (0.2%) | 0/686 (0%) | ||
CONVULSION | 3/1322 (0.2%) | 1/686 (0.1%) | ||
DIABETIC NEUROPATHY | 0/1322 (0%) | 1/686 (0.1%) | ||
DIZZINESS | 6/1322 (0.5%) | 1/686 (0.1%) | ||
DYSARTHRIA | 2/1322 (0.2%) | 0/686 (0%) | ||
EMBOLIC STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
ENCEPHALOPATHY | 2/1322 (0.2%) | 2/686 (0.3%) | ||
GUILLAIN-BARRE SYNDROME | 2/1322 (0.2%) | 0/686 (0%) | ||
HAEMORRHAGE INTRACRANIAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HAEMORRHAGIC STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
HEADACHE | 2/1322 (0.2%) | 3/686 (0.4%) | ||
HEMIPARESIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HEMIPLEGIC MIGRAINE | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC ENCEPHALOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPOAESTHESIA | 1/1322 (0.1%) | 3/686 (0.4%) | ||
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | 2/1322 (0.2%) | 0/686 (0%) | ||
ISCHAEMIC STROKE | 5/1322 (0.4%) | 3/686 (0.4%) | ||
LATERAL MEDULLARY SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
LOSS OF CONSCIOUSNESS | 1/1322 (0.1%) | 0/686 (0%) | ||
LUMBAR RADICULOPATHY | 2/1322 (0.2%) | 1/686 (0.1%) | ||
METABOLIC ENCEPHALOPATHY | 2/1322 (0.2%) | 0/686 (0%) | ||
MIGRAINE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MYELOMALACIA | 1/1322 (0.1%) | 0/686 (0%) | ||
NEUROLOGICAL SYMPTOM | 1/1322 (0.1%) | 0/686 (0%) | ||
NYSTAGMUS | 1/1322 (0.1%) | 0/686 (0%) | ||
PARAESTHESIA | 4/1322 (0.3%) | 1/686 (0.1%) | ||
POLYNEUROPATHY ALCOHOLIC | 1/1322 (0.1%) | 0/686 (0%) | ||
POST-TRAUMATIC HEADACHE | 0/1322 (0%) | 1/686 (0.1%) | ||
PRESYNCOPE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
RADICULITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
RADICULITIS CERVICAL | 1/1322 (0.1%) | 0/686 (0%) | ||
SPONDYLITIC MYELOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBARACHNOID HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SUBDURAL HYGROMA | 2/1322 (0.2%) | 0/686 (0%) | ||
SYNCOPE | 24/1322 (1.8%) | 13/686 (1.9%) | ||
THALAMIC INFARCTION | 3/1322 (0.2%) | 0/686 (0%) | ||
THROMBOTIC STROKE | 0/1322 (0%) | 1/686 (0.1%) | ||
TRANSIENT ISCHAEMIC ATTACK | 11/1322 (0.8%) | 6/686 (0.9%) | ||
UNRESPONSIVE TO STIMULI | 1/1322 (0.1%) | 0/686 (0%) | ||
URAEMIC ENCEPHALOPATHY | 0/1322 (0%) | 1/686 (0.1%) | ||
VERTEBRAL ARTERY OCCLUSION | 0/1322 (0%) | 1/686 (0.1%) | ||
VITH NERVE PARALYSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
Psychiatric disorders | ||||
ACUTE STRESS DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT | 0/1322 (0%) | 1/686 (0.1%) | ||
ALCOHOL ABUSE | 1/1322 (0.1%) | 0/686 (0%) | ||
ALCOHOL WITHDRAWAL SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
ANXIETY | 2/1322 (0.2%) | 1/686 (0.1%) | ||
BIPOLAR DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
COMPLETED SUICIDE | 0/1322 (0%) | 1/686 (0.1%) | ||
CONFUSIONAL STATE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DELIRIUM | 0/1322 (0%) | 1/686 (0.1%) | ||
DELIRIUM TREMENS | 0/1322 (0%) | 1/686 (0.1%) | ||
DEPRESSION SUICIDAL | 1/1322 (0.1%) | 0/686 (0%) | ||
HALLUCINATION, VISUAL | 0/1322 (0%) | 1/686 (0.1%) | ||
INTENTIONAL SELF-INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
MAJOR DEPRESSION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MENTAL STATUS CHANGES | 5/1322 (0.4%) | 2/686 (0.3%) | ||
PANIC ATTACK | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SUICIDAL IDEATION | 0/1322 (0%) | 2/686 (0.3%) | ||
Renal and urinary disorders | ||||
CALCULUS URETERIC | 1/1322 (0.1%) | 3/686 (0.4%) | ||
HAEMATURIA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
HYDRONEPHROSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
NEPHROLITHIASIS | 7/1322 (0.5%) | 7/686 (1%) | ||
RENAL ARTERY STENOSIS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
RENAL DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL FAILURE | 5/1322 (0.4%) | 4/686 (0.6%) | ||
RENAL FAILURE ACUTE | 12/1322 (0.9%) | 12/686 (1.7%) | ||
RENAL FAILURE CHRONIC | 2/1322 (0.2%) | 3/686 (0.4%) | ||
RENAL IMPAIRMENT | 0/1322 (0%) | 1/686 (0.1%) | ||
RENAL TUBULAR NECROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
STRESS URINARY INCONTINENCE | 1/1322 (0.1%) | 0/686 (0%) | ||
URINARY RETENTION | 4/1322 (0.3%) | 1/686 (0.1%) | ||
Reproductive system and breast disorders | ||||
BENIGN PROSTATIC HYPERPLASIA | 3/1322 (0.2%) | 3/686 (0.4%) | ||
FALLOPIAN TUBE CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
PELVIC HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
UTERINE POLYP | 1/1322 (0.1%) | 0/686 (0%) | ||
VAGINAL HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
VULVA CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE PULMONARY OEDEMA | 0/1322 (0%) | 4/686 (0.6%) | ||
ACUTE RESPIRATORY FAILURE | 16/1322 (1.2%) | 7/686 (1%) | ||
ASPIRATION | 1/1322 (0.1%) | 0/686 (0%) | ||
ASTHMA | 2/1322 (0.2%) | 0/686 (0%) | ||
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 28/1322 (2.1%) | 10/686 (1.5%) | ||
DYSPHONIA | 1/1322 (0.1%) | 0/686 (0%) | ||
DYSPNOEA | 33/1322 (2.5%) | 13/686 (1.9%) | ||
DYSPNOEA EXERTIONAL | 5/1322 (0.4%) | 3/686 (0.4%) | ||
EPISTAXIS | 2/1322 (0.2%) | 0/686 (0%) | ||
HAEMOPTYSIS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
HYPERVENTILATION | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPOXIA | 2/1322 (0.2%) | 2/686 (0.3%) | ||
INTERSTITIAL LUNG DISEASE | 1/1322 (0.1%) | 0/686 (0%) | ||
MEDIASTINAL MASS | 0/1322 (0%) | 1/686 (0.1%) | ||
NASAL POLYPS | 0/1322 (0%) | 1/686 (0.1%) | ||
NON-CARDIOGENIC PULMONARY OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ORGANISING PNEUMONIA | 0/1322 (0%) | 1/686 (0.1%) | ||
PLEURAL EFFUSION | 4/1322 (0.3%) | 3/686 (0.4%) | ||
PLEURITIC PAIN | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PNEUMONIA ASPIRATION | 0/1322 (0%) | 4/686 (0.6%) | ||
PNEUMONITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMOTHORAX | 2/1322 (0.2%) | 5/686 (0.7%) | ||
PULMONARY EMBOLISM | 9/1322 (0.7%) | 7/686 (1%) | ||
PULMONARY OEDEMA | 3/1322 (0.2%) | 1/686 (0.1%) | ||
RESPIRATORY ARREST | 2/1322 (0.2%) | 0/686 (0%) | ||
RESPIRATORY FAILURE | 13/1322 (1%) | 8/686 (1.2%) | ||
TRACHEAL STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
DIABETIC FOOT | 2/1322 (0.2%) | 0/686 (0%) | ||
RASH | 1/1322 (0.1%) | 0/686 (0%) | ||
SKIN ULCER | 4/1322 (0.3%) | 1/686 (0.1%) | ||
Surgical and medical procedures | ||||
AORTIC ANEURYSM REPAIR | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLECYSTECTOMY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
COLOSTOMY | 0/1322 (0%) | 1/686 (0.1%) | ||
CORONARY ARTERY BYPASS | 1/1322 (0.1%) | 0/686 (0%) | ||
HIP ARTHROPLASTY | 3/1322 (0.2%) | 0/686 (0%) | ||
INGUINAL HERNIA REPAIR | 0/1322 (0%) | 1/686 (0.1%) | ||
KNEE ARTHROPLASTY | 1/1322 (0.1%) | 0/686 (0%) | ||
LEG AMPUTATION | 0/1322 (0%) | 1/686 (0.1%) | ||
MEDICAL DEVICE REMOVAL | 0/1322 (0%) | 1/686 (0.1%) | ||
NEPHRECTOMY | 1/1322 (0.1%) | 0/686 (0%) | ||
SPINAL FUSION SURGERY | 1/1322 (0.1%) | 0/686 (0%) | ||
TENDON OPERATION | 0/1322 (0%) | 1/686 (0.1%) | ||
TRANSURETHRAL PROSTATECTOMY | 0/1322 (0%) | 1/686 (0.1%) | ||
Vascular disorders | ||||
ACCELERATED HYPERTENSION | 3/1322 (0.2%) | 1/686 (0.1%) | ||
AORTIC ANEURYSM | 6/1322 (0.5%) | 2/686 (0.3%) | ||
AORTIC DISSECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
AORTIC INTRAMURAL HAEMATOMA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
AORTIC STENOSIS | 4/1322 (0.3%) | 5/686 (0.7%) | ||
ARTERIAL SPASM | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTERIOSCLEROSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD PRESSURE INADEQUATELY CONTROLLED | 1/1322 (0.1%) | 0/686 (0%) | ||
CIRCULATORY COLLAPSE | 0/1322 (0%) | 1/686 (0.1%) | ||
DEEP VEIN THROMBOSIS | 11/1322 (0.8%) | 4/686 (0.6%) | ||
FEMORAL ARTERIAL STENOSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPERTENSION | 8/1322 (0.6%) | 2/686 (0.3%) | ||
HYPERTENSIVE CRISIS | 3/1322 (0.2%) | 5/686 (0.7%) | ||
HYPOTENSION | 5/1322 (0.4%) | 4/686 (0.6%) | ||
ILIAC ARTERY STENOSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
INTERMITTENT CLAUDICATION | 8/1322 (0.6%) | 7/686 (1%) | ||
MALIGNANT HYPERTENSION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORTHOSTATIC HYPOTENSION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 3/1322 (0.2%) | 8/686 (1.2%) | ||
PERIPHERAL ISCHAEMIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PERIPHERAL VASCULAR DISORDER | 7/1322 (0.5%) | 6/686 (0.9%) | ||
SUBCLAVIAN ARTERY OCCLUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBCLAVIAN ARTERY STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBCLAVIAN STEAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
THROMBOSIS | 2/1322 (0.2%) | 0/686 (0%) | ||
VASOSPAM | 1/1322 (0.1%) | 0/686 (0%) | ||
VENOUS INSUFFICIENCY | 1/1322 (0.1%) | 0/686 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Absorb BVS | XIENCE | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1174/1322 (88.8%) | 601/686 (87.6%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 21/1322 (1.6%) | 16/686 (2.3%) | ||
ANAEMIA OF CHRONIC DISEASE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
COAGULOPATHY | 0/1322 (0%) | 2/686 (0.3%) | ||
FEBRILE NEUTROPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMORRHAGIC ANAEMIA | 2/1322 (0.2%) | 4/686 (0.6%) | ||
HAEMORRHAGIC DIATHESIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
HEPARIN-INDUCED THROMBOCYTOPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
IRON DEFICIENCY ANAEMIA | 3/1322 (0.2%) | 1/686 (0.1%) | ||
LEUKOCYTOSIS | 5/1322 (0.4%) | 2/686 (0.3%) | ||
LYMPHADENITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
LYMPHADENOPATHY | 2/1322 (0.2%) | 0/686 (0%) | ||
MICROCYTIC ANAEMIA | 2/1322 (0.2%) | 0/686 (0%) | ||
NORMOCHROMIC NORMOCYTIC ANAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
SPLENIC INFARCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
THROMBOCYTOPENIA | 2/1322 (0.2%) | 2/686 (0.3%) | ||
Cardiac disorders | ||||
ACUTE CORONARY SYNDROME | 6/1322 (0.5%) | 5/686 (0.7%) | ||
ACUTE LEFT VENTRICULAR FAILURE | 0/1322 (0%) | 1/686 (0.1%) | ||
ACUTE MYOCARDIAL INFARCTION | 49/1322 (3.7%) | 22/686 (3.2%) | ||
ANGINA PECTORIS | 381/1322 (28.8%) | 202/686 (29.4%) | ||
ANGINA UNSTABLE | 77/1322 (5.8%) | 29/686 (4.2%) | ||
AORTIC VALVE DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
AORTIC VALVE INCOMPETENCE | 2/1322 (0.2%) | 0/686 (0%) | ||
AORTIC VALVE STENOSIS | 8/1322 (0.6%) | 2/686 (0.3%) | ||
ARRHYTHMIA | 1/1322 (0.1%) | 3/686 (0.4%) | ||
ARTERIOSCLEROSIS CORONARY ARTERY | 4/1322 (0.3%) | 0/686 (0%) | ||
ARTERIOSPASM CORONARY | 4/1322 (0.3%) | 4/686 (0.6%) | ||
ATRIAL FIBRILLATION | 95/1322 (7.2%) | 42/686 (6.1%) | ||
ATRIAL FLUTTER | 11/1322 (0.8%) | 3/686 (0.4%) | ||
ATRIAL HYPERTROPHY | 0/1322 (0%) | 1/686 (0.1%) | ||
ATRIAL TACHYCARDIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ATRIAL THROMBOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ATRIOVENTRICULAR BLOCK | 6/1322 (0.5%) | 0/686 (0%) | ||
ATRIOVENTRICULAR BLOCK COMPLETE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ATRIOVENTRICULAR BLOCK SECOND DEGREE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
BRADYCARDIA | 31/1322 (2.3%) | 13/686 (1.9%) | ||
BUNDLE BRANCH BLOCK | 0/1322 (0%) | 1/686 (0.1%) | ||
BUNDLE BRANCH BLOCK LEFT | 0/1322 (0%) | 1/686 (0.1%) | ||
BUNDLE BRANCH BLOCK RIGHT | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CARDIAC ARREST | 10/1322 (0.8%) | 6/686 (0.9%) | ||
CARDIAC FAILURE | 8/1322 (0.6%) | 4/686 (0.6%) | ||
CARDIAC FAILURE ACUTE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
CARDIAC FAILURE CHRONIC | 2/1322 (0.2%) | 3/686 (0.4%) | ||
CARDIAC FAILURE CONGESTIVE | 39/1322 (3%) | 30/686 (4.4%) | ||
CARDIAC FLUTTER | 2/1322 (0.2%) | 1/686 (0.1%) | ||
CARDIAC TAMPONADE | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIAC VALVE DISEASE | 2/1322 (0.2%) | 0/686 (0%) | ||
CARDIO-RESPIRATORY ARREST | 2/1322 (0.2%) | 1/686 (0.1%) | ||
CARDIOGENIC SHOCK | 1/1322 (0.1%) | 3/686 (0.4%) | ||
CARDIOMEGALY | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIOMYOPATHY | 1/1322 (0.1%) | 2/686 (0.3%) | ||
CARDIORENAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
CHRONIC LEFT VENTRICULAR FAILURE | 1/1322 (0.1%) | 0/686 (0%) | ||
CONDUCTION DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
CONGESTIVE CARDIOMYOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
CORONARY ARTERY DISEASE | 44/1322 (3.3%) | 28/686 (4.1%) | ||
CORONARY ARTERY DISSECTION | 85/1322 (6.4%) | 56/686 (8.2%) | ||
CORONARY ARTERY EMBOLISM | 3/1322 (0.2%) | 4/686 (0.6%) | ||
CORONARY ARTERY OCCLUSION | 5/1322 (0.4%) | 2/686 (0.3%) | ||
CORONARY ARTERY PERFORATION | 7/1322 (0.5%) | 3/686 (0.4%) | ||
CORONARY ARTERY STENOSIS | 23/1322 (1.7%) | 14/686 (2%) | ||
CORONARY NO-REFLOW PHENOMENON | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CORONARY OSTIAL STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
CYANOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
DIASTOLIC DYSFUNCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
DRESSLER'S SYNDROME | 0/1322 (0%) | 3/686 (0.4%) | ||
EXTRASYSTOLES | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HEART VALVE INCOMPETENCE | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPERTROPHIC CARDIOMYOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 4/1322 (0.3%) | 5/686 (0.7%) | ||
INTRACARDIAC THROMBUS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ISCHAEMIC CARDIOMYOPATHY | 4/1322 (0.3%) | 2/686 (0.3%) | ||
LEFT VENTRICULAR DYSFUNCTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LEFT VENTRICULAR HYPERTROPHY | 1/1322 (0.1%) | 0/686 (0%) | ||
MITRAL VALVE INCOMPETENCE | 8/1322 (0.6%) | 1/686 (0.1%) | ||
MYOCARDIAL INFARCTION | 54/1322 (4.1%) | 24/686 (3.5%) | ||
MYOCARDIAL ISCHAEMIA | 6/1322 (0.5%) | 1/686 (0.1%) | ||
NODAL ARRHYTHMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
NODAL RHYTHM | 1/1322 (0.1%) | 0/686 (0%) | ||
PALPITATIONS | 32/1322 (2.4%) | 17/686 (2.5%) | ||
PERICARDIAL EFFUSION | 6/1322 (0.5%) | 3/686 (0.4%) | ||
PERICARDITIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PRINZMETAL ANGINA | 2/1322 (0.2%) | 0/686 (0%) | ||
SICK SINUS SYNDROME | 6/1322 (0.5%) | 4/686 (0.6%) | ||
SINUS ARREST | 1/1322 (0.1%) | 0/686 (0%) | ||
SINUS ARRHYTHMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
SINUS BRADYCARDIA | 3/1322 (0.2%) | 3/686 (0.4%) | ||
SINUS TACHYCARDIA | 2/1322 (0.2%) | 0/686 (0%) | ||
SUPRAVENTRICULAR EXTRASYSTOLES | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SUPRAVENTRICULAR TACHYCARDIA | 12/1322 (0.9%) | 5/686 (0.7%) | ||
TACHYCARDIA | 12/1322 (0.9%) | 6/686 (0.9%) | ||
TORSADE DE POINTES | 1/1322 (0.1%) | 0/686 (0%) | ||
TRICUSPID VALVE INCOMPETENCE | 2/1322 (0.2%) | 0/686 (0%) | ||
VENTRICULAR ARRHYTHMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
VENTRICULAR EXTRASYSTOLES | 6/1322 (0.5%) | 0/686 (0%) | ||
VENTRICULAR FIBRILLATION | 6/1322 (0.5%) | 0/686 (0%) | ||
VENTRICULAR TACHYCARDIA | 14/1322 (1.1%) | 6/686 (0.9%) | ||
Congenital, familial and genetic disorders | ||||
ARTERIOVENOUS MALFORMATION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CYSTIC LYMPHANGIOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
MYOTONIC DYSTROPHY | 1/1322 (0.1%) | 0/686 (0%) | ||
PULMONARY ARTERIOVENOUS FISTULA | 0/1322 (0%) | 1/686 (0.1%) | ||
Ear and labyrinth disorders | ||||
DEAFNESS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
EAR PAIN | 0/1322 (0%) | 2/686 (0.3%) | ||
EUSTACHIAN TUBE OBSTRUCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
MIXED DEAFNESS | 1/1322 (0.1%) | 0/686 (0%) | ||
TINNITUS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
TYMPANIC MEMBRANE PERFORATION | 1/1322 (0.1%) | 0/686 (0%) | ||
VERTIGO | 13/1322 (1%) | 7/686 (1%) | ||
Endocrine disorders | ||||
ADRENAL MASS | 1/1322 (0.1%) | 0/686 (0%) | ||
GOITRE | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPERTHYROIDISM | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPOGONADISM | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPOTHYROIDISM | 6/1322 (0.5%) | 1/686 (0.1%) | ||
THYROID CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
Eye disorders | ||||
AGE-RELATED MACULAR DEGENERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
AMAUROSIS FUGAX | 1/1322 (0.1%) | 0/686 (0%) | ||
CATARACT | 7/1322 (0.5%) | 8/686 (1.2%) | ||
CATARACT NUCLEAR | 1/1322 (0.1%) | 0/686 (0%) | ||
CONJUNCTIVAL HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
CONJUNCTIVITIS | 2/1322 (0.2%) | 2/686 (0.3%) | ||
DIABETIC RETINOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
DIPLOPIA | 1/1322 (0.1%) | 0/686 (0%) | ||
EYE PRURITUS | 1/1322 (0.1%) | 0/686 (0%) | ||
EYE SWELLING | 0/1322 (0%) | 1/686 (0.1%) | ||
GAZE PALSY | 1/1322 (0.1%) | 0/686 (0%) | ||
GLAUCOMA | 4/1322 (0.3%) | 0/686 (0%) | ||
MACULAR FIBROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
MACULAR OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PAPILLOEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
POSTERIOR CAPSULE OPACIFICATION | 1/1322 (0.1%) | 0/686 (0%) | ||
RETINAL DETACHMENT | 2/1322 (0.2%) | 1/686 (0.1%) | ||
RETINAL HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SCLERAL DISCOLOURATION | 1/1322 (0.1%) | 0/686 (0%) | ||
SCLERAL HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
VISION BLURRED | 5/1322 (0.4%) | 1/686 (0.1%) | ||
VISUAL IMPAIRMENT | 2/1322 (0.2%) | 0/686 (0%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL DISCOMFORT | 5/1322 (0.4%) | 4/686 (0.6%) | ||
ABDOMINAL DISTENSION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ABDOMINAL HERNIA | 3/1322 (0.2%) | 3/686 (0.4%) | ||
ABDOMINAL HERNIA OBSTRUCTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
ABDOMINAL MASS | 0/1322 (0%) | 1/686 (0.1%) | ||
ABDOMINAL PAIN | 13/1322 (1%) | 13/686 (1.9%) | ||
ABDOMINAL PAIN LOWER | 1/1322 (0.1%) | 0/686 (0%) | ||
ABDOMINAL PAIN UPPER | 8/1322 (0.6%) | 7/686 (1%) | ||
ABDOMINAL WALL HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ALCOHOLIC PANCREATITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
BARRETT'S OESOPHAGUS | 3/1322 (0.2%) | 0/686 (0%) | ||
COELIAC ARTERY STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
COELIAC DISEASE | 0/1322 (0%) | 1/686 (0.1%) | ||
COLITIS | 4/1322 (0.3%) | 3/686 (0.4%) | ||
COLITIS ISCHAEMIC | 1/1322 (0.1%) | 1/686 (0.1%) | ||
COLONIC POLYP | 3/1322 (0.2%) | 1/686 (0.1%) | ||
CONSTIPATION | 11/1322 (0.8%) | 2/686 (0.3%) | ||
CROHN'S DISEASE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
DENTAL CARIES | 1/1322 (0.1%) | 0/686 (0%) | ||
DIABETIC GASTROPARESIS | 1/1322 (0.1%) | 0/686 (0%) | ||
DIARRHOEA | 18/1322 (1.4%) | 7/686 (1%) | ||
DIVERTICULUM | 3/1322 (0.2%) | 1/686 (0.1%) | ||
DIVERTICULUM INTESTINAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DIVERTICULUM INTESTINAL HAEMORRHAGIC | 2/1322 (0.2%) | 1/686 (0.1%) | ||
DRY MOUTH | 1/1322 (0.1%) | 0/686 (0%) | ||
DUODENAL ULCER | 1/1322 (0.1%) | 0/686 (0%) | ||
DUODENAL ULCER HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
DUODENITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
DYSPEPSIA | 15/1322 (1.1%) | 4/686 (0.6%) | ||
DYSPHAGIA | 10/1322 (0.8%) | 2/686 (0.3%) | ||
ENTEROVESICAL FISTULA | 1/1322 (0.1%) | 0/686 (0%) | ||
EROSIVE OESOPHAGITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ERUCTATION | 0/1322 (0%) | 1/686 (0.1%) | ||
FAECAL INCONTINENCE | 1/1322 (0.1%) | 0/686 (0%) | ||
FAECALOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
FAECES DISCOLOURED | 1/1322 (0.1%) | 1/686 (0.1%) | ||
FLATULENCE | 2/1322 (0.2%) | 0/686 (0%) | ||
FOOD POISONING | 1/1322 (0.1%) | 0/686 (0%) | ||
FUNCTIONAL GASTROINTESTINAL DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTRIC HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTRIC ULCER | 2/1322 (0.2%) | 4/686 (0.6%) | ||
GASTRIC ULCER HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTRITIS | 6/1322 (0.5%) | 3/686 (0.4%) | ||
GASTRITIS EROSIVE | 3/1322 (0.2%) | 0/686 (0%) | ||
GASTROINTESTINAL ANGIODYSPLASIA | 1/1322 (0.1%) | 0/686 (0%) | ||
GASTROINTESTINAL DISORDER | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTROINTESTINAL HAEMORRHAGE | 16/1322 (1.2%) | 15/686 (2.2%) | ||
GASTROINTESTINAL PAIN | 0/1322 (0%) | 1/686 (0.1%) | ||
GASTROINTESTINAL ULCER HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
GASTROOESOPHAGEAL REFLUX DISEASE | 23/1322 (1.7%) | 8/686 (1.2%) | ||
HAEMATEMESIS | 2/1322 (0.2%) | 2/686 (0.3%) | ||
HAEMATOCHEZIA | 4/1322 (0.3%) | 0/686 (0%) | ||
HAEMORRHOIDAL HAEMORRHAGE | 4/1322 (0.3%) | 1/686 (0.1%) | ||
HAEMORRHOIDS | 1/1322 (0.1%) | 0/686 (0%) | ||
HIATUS HERNIA | 9/1322 (0.7%) | 4/686 (0.6%) | ||
HYPOAESTHESIA ORAL | 1/1322 (0.1%) | 0/686 (0%) | ||
ILEUS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
IMPAIRED GASTRIC EMPTYING | 3/1322 (0.2%) | 1/686 (0.1%) | ||
INFREQUENT BOWEL MOVEMENTS | 1/1322 (0.1%) | 0/686 (0%) | ||
INGUINAL HERNIA | 4/1322 (0.3%) | 6/686 (0.9%) | ||
INTESTINAL MASS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
INTESTINAL OBSTRUCTION | 0/1322 (0%) | 2/686 (0.3%) | ||
IRRITABLE BOWEL SYNDROME | 2/1322 (0.2%) | 0/686 (0%) | ||
LARGE INTESTINE PERFORATION | 0/1322 (0%) | 1/686 (0.1%) | ||
LOWER GASTROINTESTINAL HAEMORRHAGE | 3/1322 (0.2%) | 2/686 (0.3%) | ||
MALLORY-WEISS SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
MELAENA | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MOUTH HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
MOUTH ULCERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
NAUSEA | 19/1322 (1.4%) | 13/686 (1.9%) | ||
OESOPHAGEAL ACHALASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
OESOPHAGEAL FOOD IMPACTION | 1/1322 (0.1%) | 0/686 (0%) | ||
OESOPHAGEAL PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
OESOPHAGEAL SPASM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OESOPHAGEAL ULCER | 1/1322 (0.1%) | 0/686 (0%) | ||
OESOPHAGITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
PANCREATIC CYST | 1/1322 (0.1%) | 3/686 (0.4%) | ||
PANCREATITIS | 1/1322 (0.1%) | 3/686 (0.4%) | ||
PANCREATITIS ACUTE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
PANCREATITIS CHRONIC | 1/1322 (0.1%) | 0/686 (0%) | ||
PEPTIC ULCER | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCTALGIA | 1/1322 (0.1%) | 0/686 (0%) | ||
RECTAL HAEMORRHAGE | 8/1322 (0.6%) | 8/686 (1.2%) | ||
RECTAL PROLAPSE | 0/1322 (0%) | 1/686 (0.1%) | ||
RETROPERITONEAL HAEMATOMA | 2/1322 (0.2%) | 0/686 (0%) | ||
RETROPERITONEAL HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
SMALL INTESTINAL OBSTRUCTION | 3/1322 (0.2%) | 6/686 (0.9%) | ||
SMALL INTESTINAL PERFORATION | 0/1322 (0%) | 1/686 (0.1%) | ||
STOMATITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
TONGUE CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
TONGUE HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
TOOTH SOCKET HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
UMBILICAL HERNIA | 4/1322 (0.3%) | 2/686 (0.3%) | ||
UMBILICAL HERNIA, OBSTRUCTIVE | 2/1322 (0.2%) | 0/686 (0%) | ||
UPPER GASTROINTESTINAL HAEMORRHAGE | 3/1322 (0.2%) | 4/686 (0.6%) | ||
VOMITING | 13/1322 (1%) | 10/686 (1.5%) | ||
General disorders | ||||
ABASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ADVERSE DRUG REACTION | 74/1322 (5.6%) | 42/686 (6.1%) | ||
ASTHENIA | 12/1322 (0.9%) | 4/686 (0.6%) | ||
BREAST COMPLICATION ASSOCIATED WITH DEVICE | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC DEATH | 1/1322 (0.1%) | 0/686 (0%) | ||
CATHETER SITE HAEMATOMA | 30/1322 (2.3%) | 14/686 (2%) | ||
CATHETER SITE HAEMORRHAGE | 22/1322 (1.7%) | 14/686 (2%) | ||
CATHETER SITE PAIN | 29/1322 (2.2%) | 15/686 (2.2%) | ||
CATHETER SITE RASH | 0/1322 (0%) | 1/686 (0.1%) | ||
CATHETER SITE RELATED REACTION | 9/1322 (0.7%) | 4/686 (0.6%) | ||
CATHETER SITE SWELLING | 5/1322 (0.4%) | 2/686 (0.3%) | ||
CHEST DISCOMFORT | 87/1322 (6.6%) | 34/686 (5%) | ||
CHEST PAIN | 79/1322 (6%) | 49/686 (7.1%) | ||
CHILLS | 0/1322 (0%) | 1/686 (0.1%) | ||
CYST | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DEATH | 10/1322 (0.8%) | 6/686 (0.9%) | ||
DEVICE ELECTRICAL FINDING | 0/1322 (0%) | 1/686 (0.1%) | ||
DEVICE FAILURE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DEVICE MALFUNCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
DEVICE OCCLUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
DISCOMFORT | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DROWNING | 1/1322 (0.1%) | 0/686 (0%) | ||
DRUG INTOLERANCE | 2/1322 (0.2%) | 0/686 (0%) | ||
DRUG WITHDRAWAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
FACE OEDEMA | 0/1322 (0%) | 1/686 (0.1%) | ||
FATIGUE | 50/1322 (3.8%) | 20/686 (2.9%) | ||
FEELING COLD | 0/1322 (0%) | 1/686 (0.1%) | ||
GAIT DISTURBANCE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
GENERALISED OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
HERNIA | 0/1322 (0%) | 1/686 (0.1%) | ||
HERNIA OBSTRUCTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
HERNIA PAIN | 0/1322 (0%) | 1/686 (0.1%) | ||
IMPAIRED HEALING | 0/1322 (0%) | 2/686 (0.3%) | ||
IMPLANT SITE HAEMORRHAGE | 1/1322 (0.1%) | 0/686 (0%) | ||
IMPLANT SITE PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
INFLUENZA LIKE ILLNESS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
LOCAL SWELLING | 2/1322 (0.2%) | 0/686 (0%) | ||
MALAISE | 3/1322 (0.2%) | 1/686 (0.1%) | ||
MASS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MEDICAL DEVICE SITE REACTION | 1/1322 (0.1%) | 0/686 (0%) | ||
MULTI-ORGAN FAILURE | 1/1322 (0.1%) | 2/686 (0.3%) | ||
NON-CARDIAC CHEST PAIN | 271/1322 (20.5%) | 122/686 (17.8%) | ||
OEDEMA | 2/1322 (0.2%) | 0/686 (0%) | ||
OEDEMA PERIPHERAL | 25/1322 (1.9%) | 10/686 (1.5%) | ||
PAIN | 9/1322 (0.7%) | 6/686 (0.9%) | ||
PELVIC MASS | 0/1322 (0%) | 2/686 (0.3%) | ||
PYREXIA | 9/1322 (0.7%) | 3/686 (0.4%) | ||
SPINAL PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
SUDDEN CARDIAC DEATH | 0/1322 (0%) | 1/686 (0.1%) | ||
SURGICAL FAILURE | 1/1322 (0.1%) | 0/686 (0%) | ||
SWELLING | 1/1322 (0.1%) | 0/686 (0%) | ||
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | 3/1322 (0.2%) | 1/686 (0.1%) | ||
THROMBOSIS IN DEVICE | 14/1322 (1.1%) | 6/686 (0.9%) | ||
Hepatobiliary disorders | ||||
BILE DUCT STONE | 2/1322 (0.2%) | 0/686 (0%) | ||
BILIARY COLIC | 0/1322 (0%) | 1/686 (0.1%) | ||
CHOLANGITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLECYSTITIS | 4/1322 (0.3%) | 2/686 (0.3%) | ||
CHOLECYSTITIS ACUTE | 2/1322 (0.2%) | 4/686 (0.6%) | ||
CHOLECYSTITIS CHRONIC | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLELITHIASIS | 12/1322 (0.9%) | 6/686 (0.9%) | ||
GALLBLADDER DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC LESION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
HEPATIC STEATOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATOMEGALY | 0/1322 (0%) | 1/686 (0.1%) | ||
ISCHAEMIC HEPATITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PORTAL VEIN THROMBOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
Immune system disorders | ||||
ALLERGY TO ARTHROPOD STING | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ANAPHYLACTIC REACTION | 1/1322 (0.1%) | 0/686 (0%) | ||
CONTRAST MEDIA ALLERGY | 2/1322 (0.2%) | 2/686 (0.3%) | ||
DRUG HYPERSENSITIVITY | 5/1322 (0.4%) | 4/686 (0.6%) | ||
FOOD ALLERGY | 2/1322 (0.2%) | 0/686 (0%) | ||
HYPERSENSITIVITY | 0/1322 (0%) | 2/686 (0.3%) | ||
SEASONAL ALLERGY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
Infections and infestations | ||||
ABDOMINAL ABSCESS | 0/1322 (0%) | 1/686 (0.1%) | ||
ABDOMINAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
ABSCESS NECK | 1/1322 (0.1%) | 0/686 (0%) | ||
ACUTE SINUSITIS | 3/1322 (0.2%) | 1/686 (0.1%) | ||
ACUTE TONSILLITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
APPENDICITIS | 4/1322 (0.3%) | 2/686 (0.3%) | ||
APPENDICITIS PERFORATED | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTERIOVENOUS GRAFT SITE INFECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
ARTHRITIS BACTERIAL | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTHRITIS INFECTIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
BACTERAEMIA | 4/1322 (0.3%) | 0/686 (0%) | ||
BACTERIAL DISEASE CARRIER | 0/1322 (0%) | 1/686 (0.1%) | ||
BACTERIAL INFECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
BACTERIAL SEPSIS | 0/1322 (0%) | 2/686 (0.3%) | ||
BREAST ABSCESS | 0/1322 (0%) | 1/686 (0.1%) | ||
BREAST CELLULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
BRONCHITIS | 34/1322 (2.6%) | 21/686 (3.1%) | ||
BRONCHITIS VIRAL | 1/1322 (0.1%) | 0/686 (0%) | ||
BRONCHOPNEUMONIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CARBUNCLE | 0/1322 (0%) | 1/686 (0.1%) | ||
CATHETER SITE ABSCESS | 2/1322 (0.2%) | 0/686 (0%) | ||
CATHETER SITE CELLULITIS | 3/1322 (0.2%) | 0/686 (0%) | ||
CATHETER SITE INFECTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CELLULITIS | 15/1322 (1.1%) | 14/686 (2%) | ||
CHOLECYSTITIS INFECTIVE | 0/1322 (0%) | 2/686 (0.3%) | ||
CLOSTRIDIAL INFECTION | 4/1322 (0.3%) | 1/686 (0.1%) | ||
CLOSTRIDIUM DIFFICILE COLITIS | 3/1322 (0.2%) | 3/686 (0.4%) | ||
CYSTITIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
DIABETIC FOOT INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
DIVERTICULITIS | 5/1322 (0.4%) | 3/686 (0.4%) | ||
EAR INFECTION | 3/1322 (0.2%) | 0/686 (0%) | ||
ENDOCARDITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ENTEROCOCCAL SEPSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
ESCHERICHIA BACTERAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
ESCHERICHIA URINARY TRACT INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
EYELID INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
FOLLICULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
FUNGAL INFECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
FURUNCLE | 1/1322 (0.1%) | 0/686 (0%) | ||
GANGRENE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
GASTROENTERITIS | 10/1322 (0.8%) | 3/686 (0.4%) | ||
GASTROENTERITIS VIRAL | 4/1322 (0.3%) | 3/686 (0.4%) | ||
GENITAL INFECTION FEMALE | 1/1322 (0.1%) | 0/686 (0%) | ||
GROIN ABSCESS | 1/1322 (0.1%) | 0/686 (0%) | ||
HELICOBACTER INFECTION | 2/1322 (0.2%) | 0/686 (0%) | ||
HEPATITIS C | 2/1322 (0.2%) | 0/686 (0%) | ||
HERPES ZOSTER | 7/1322 (0.5%) | 3/686 (0.4%) | ||
HERPES ZOSTER OPHTHALMIC | 1/1322 (0.1%) | 0/686 (0%) | ||
HIV INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
IMPLANT SITE INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
INFECTED DERMAL CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
INFECTED SKIN ULCER | 0/1322 (0%) | 1/686 (0.1%) | ||
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | 1/1322 (0.1%) | 0/686 (0%) | ||
INFLUENZA | 8/1322 (0.6%) | 8/686 (1.2%) | ||
KIDNEY INFECTION | 4/1322 (0.3%) | 0/686 (0%) | ||
LARYNGITIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
LOBAR PNEUMONIA | 3/1322 (0.2%) | 1/686 (0.1%) | ||
LOCALISED INFECTION | 0/1322 (0%) | 3/686 (0.4%) | ||
LUNG ABSCESS | 0/1322 (0%) | 1/686 (0.1%) | ||
MENINGITIS ASEPTIC | 1/1322 (0.1%) | 0/686 (0%) | ||
METAPNEUMOVIRUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
MYCOBACTERIUM ABSCESSUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
NASOPHARYNGITIS | 6/1322 (0.5%) | 5/686 (0.7%) | ||
ONYCHOMYCOSIS | 2/1322 (0.2%) | 0/686 (0%) | ||
ORAL FUNGAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORCHITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
OSTEOMYELITIS | 3/1322 (0.2%) | 4/686 (0.6%) | ||
OTITIS EXTERNA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OTITIS MEDIA | 1/1322 (0.1%) | 0/686 (0%) | ||
OTITIS MEDIA ACUTE | 1/1322 (0.1%) | 0/686 (0%) | ||
PARONYCHIA | 2/1322 (0.2%) | 0/686 (0%) | ||
PERITONITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
PERITONSILLAR ABSCESS | 1/1322 (0.1%) | 0/686 (0%) | ||
PHARYNGITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PHARYNGITIS STREPTOCOCCAL | 0/1322 (0%) | 1/686 (0.1%) | ||
PILONIDAL CYST | 0/1322 (0%) | 1/686 (0.1%) | ||
PNEUMONIA | 33/1322 (2.5%) | 27/686 (3.9%) | ||
PNEUMONIA ADENOVIRAL | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA BACTERIAL | 2/1322 (0.2%) | 0/686 (0%) | ||
PNEUMONIA NECROTISING | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA PRIMARY ATYPICAL | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMONIA STAPHYLOCOCCAL | 2/1322 (0.2%) | 0/686 (0%) | ||
POST PROCEDURAL CELLULITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL INFECTION | 3/1322 (0.2%) | 0/686 (0%) | ||
POST PROCEDURAL PNEUMONIA | 1/1322 (0.1%) | 0/686 (0%) | ||
POSTOPERATIVE WOUND INFECTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PROSTATE INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
PYELONEPHRITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
RESPIRATORY SYNCYTIAL VIRUS INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
RESPIRATORY TRACT INFECTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SEPSIS | 15/1322 (1.1%) | 10/686 (1.5%) | ||
SEPSIS SYNDROME | 2/1322 (0.2%) | 0/686 (0%) | ||
SEPTIC ENCEPHALOPATHY | 0/1322 (0%) | 1/686 (0.1%) | ||
SEPTIC SHOCK | 2/1322 (0.2%) | 1/686 (0.1%) | ||
SINUSITIS | 11/1322 (0.8%) | 10/686 (1.5%) | ||
SPINAL CORD INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
STAPHYLOCOCCAL BACTERAEMIA | 0/1322 (0%) | 2/686 (0.3%) | ||
STAPHYLOCOCCAL INFECTION | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBCUTANEOUS ABSCESS | 1/1322 (0.1%) | 0/686 (0%) | ||
TINEA PEDIS | 1/1322 (0.1%) | 0/686 (0%) | ||
TOOTH ABSCESS | 2/1322 (0.2%) | 2/686 (0.3%) | ||
UPPER RESPIRATORY TRACT INFECTION | 25/1322 (1.9%) | 6/686 (0.9%) | ||
URINARY TRACT INFECTION | 32/1322 (2.4%) | 23/686 (3.4%) | ||
URINARY TRACT INFECTION BACTERIAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
UROSEPSIS | 3/1322 (0.2%) | 4/686 (0.6%) | ||
VIRAL INFECTION | 4/1322 (0.3%) | 3/686 (0.4%) | ||
VIRAL LABYRINTHITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
VIRAL UPPER RESPIRATORY TRACT INFECTION | 1/1322 (0.1%) | 2/686 (0.3%) | ||
WOUND INFECTION | 2/1322 (0.2%) | 3/686 (0.4%) | ||
WOUND INFECTION BACTERIAL | 0/1322 (0%) | 1/686 (0.1%) | ||
WOUND INFECTION STAPHYLOCOCCAL | 1/1322 (0.1%) | 2/686 (0.3%) | ||
Injury, poisoning and procedural complications | ||||
ACCIDENT | 0/1322 (0%) | 1/686 (0.1%) | ||
ACCIDENTAL OVERDOSE | 2/1322 (0.2%) | 0/686 (0%) | ||
ACETABULUM FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
ALCOHOL POISONING | 3/1322 (0.2%) | 2/686 (0.3%) | ||
ANAEMIA POSTOPERATIVE | 5/1322 (0.4%) | 3/686 (0.4%) | ||
ANIMAL BITE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
ANKLE FRACTURE | 1/1322 (0.1%) | 4/686 (0.6%) | ||
ANXIETY POSTOPERATIVE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ARTHROPOD BITE | 2/1322 (0.2%) | 0/686 (0%) | ||
ARTHROPOD STING | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ASBESTOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
AVULSION FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
BURNS THIRD DEGREE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC PROCEDURE COMPLICATION | 4/1322 (0.3%) | 4/686 (0.6%) | ||
CATHETER SITE HAEMATOMA | 10/1322 (0.8%) | 8/686 (1.2%) | ||
CEREBRAL HAEMORRHAGE TRAUMATIC | 2/1322 (0.2%) | 0/686 (0%) | ||
CLAVICLE FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
COLON INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
CONCUSSION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CONTRAST MEDIA ALLERGY | 0/1322 (0%) | 1/686 (0.1%) | ||
CONTUSION | 25/1322 (1.9%) | 6/686 (0.9%) | ||
CORNEAL ABRASION | 0/1322 (0%) | 1/686 (0.1%) | ||
CORONARY ARTERY RESTENOSIS | 51/1322 (3.9%) | 15/686 (2.2%) | ||
CRANIOCEREBRAL INJURY | 3/1322 (0.2%) | 1/686 (0.1%) | ||
CYSTITIS RADIATION | 1/1322 (0.1%) | 0/686 (0%) | ||
DEEP VEIN THROMBOSIS POSTOPERATIVE | 2/1322 (0.2%) | 0/686 (0%) | ||
DRUG ADMINISTRATION ERROR | 1/1322 (0.1%) | 0/686 (0%) | ||
EXCORIATION | 2/1322 (0.2%) | 0/686 (0%) | ||
EXPOSURE TO TOXIC AGENT | 2/1322 (0.2%) | 0/686 (0%) | ||
FACIAL BONES FRACTURE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
FALL | 28/1322 (2.1%) | 20/686 (2.9%) | ||
FEMORAL NECK FRACTURE | 0/1322 (0%) | 2/686 (0.3%) | ||
FEMUR FRACTURE | 3/1322 (0.2%) | 0/686 (0%) | ||
FOOT FRACTURE | 4/1322 (0.3%) | 1/686 (0.1%) | ||
FOREIGN BODY | 0/1322 (0%) | 1/686 (0.1%) | ||
GASTROINTESTINAL ANASTOMOTIC LEAK | 0/1322 (0%) | 1/686 (0.1%) | ||
HAEMATURIA TRAUMATIC | 1/1322 (0.1%) | 0/686 (0%) | ||
HAND FRACTURE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HEAD INJURY | 1/1322 (0.1%) | 2/686 (0.3%) | ||
HIP FRACTURE | 4/1322 (0.3%) | 2/686 (0.3%) | ||
HUMERUS FRACTURE | 3/1322 (0.2%) | 2/686 (0.3%) | ||
ILIOTIBIAL BAND SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
IN-STENT ARTERIAL RESTENOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
IN-STENT CORONARY ARTERY RESTENOSIS | 8/1322 (0.6%) | 6/686 (0.9%) | ||
INCISION SITE PRURITUS | 0/1322 (0%) | 1/686 (0.1%) | ||
INCISIONAL HERNIA | 3/1322 (0.2%) | 0/686 (0%) | ||
INJURY | 2/1322 (0.2%) | 0/686 (0%) | ||
JOINT DISLOCATION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
JOINT INJURY | 2/1322 (0.2%) | 0/686 (0%) | ||
LACERATION | 7/1322 (0.5%) | 4/686 (0.6%) | ||
LIGAMENT RUPTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
LIGAMENT SPRAIN | 1/1322 (0.1%) | 6/686 (0.9%) | ||
LIMB INJURY | 3/1322 (0.2%) | 4/686 (0.6%) | ||
LIMB TRAUMATIC AMPUTATION | 1/1322 (0.1%) | 0/686 (0%) | ||
LOWER LIMB FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
MENISCUS LESION | 8/1322 (0.6%) | 4/686 (0.6%) | ||
MOUTH INJURY | 0/1322 (0%) | 1/686 (0.1%) | ||
MULTIPLE FRACTURES | 2/1322 (0.2%) | 0/686 (0%) | ||
MULTIPLE INJURIES | 1/1322 (0.1%) | 0/686 (0%) | ||
MUSCLE RUPTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
MUSCLE STRAIN | 2/1322 (0.2%) | 1/686 (0.1%) | ||
PELVIC FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
PERIORBITAL HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PLAQUE SHIFT | 4/1322 (0.3%) | 6/686 (0.9%) | ||
POST CONCUSSION SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL CONSTIPATION | 0/1322 (0%) | 1/686 (0.1%) | ||
POST PROCEDURAL DISCOMFORT | 0/1322 (0%) | 1/686 (0.1%) | ||
POST PROCEDURAL HAEMATOMA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
POST PROCEDURAL HAEMORRHAGE | 6/1322 (0.5%) | 4/686 (0.6%) | ||
POST PROCEDURAL MYOCARDIAL INFARCTION | 12/1322 (0.9%) | 7/686 (1%) | ||
POST PROCEDURAL STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
POST PROCEDURAL SWELLING | 0/1322 (0%) | 1/686 (0.1%) | ||
POST-TRAUMATIC NECK SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
POST-TRAUMATIC PAIN | 4/1322 (0.3%) | 1/686 (0.1%) | ||
POSTOPERATIVE ADHESION | 1/1322 (0.1%) | 0/686 (0%) | ||
POSTOPERATIVE FEVER | 1/1322 (0.1%) | 0/686 (0%) | ||
PROCEDURAL COMPLICATION | 2/1322 (0.2%) | 0/686 (0%) | ||
PROCEDURAL DIZZINESS | 1/1322 (0.1%) | 2/686 (0.3%) | ||
PROCEDURAL HEADACHE | 5/1322 (0.4%) | 2/686 (0.3%) | ||
PROCEDURAL HYPERTENSION | 10/1322 (0.8%) | 4/686 (0.6%) | ||
PROCEDURAL HYPOTENSION | 13/1322 (1%) | 7/686 (1%) | ||
PROCEDURAL NAUSEA | 8/1322 (0.6%) | 4/686 (0.6%) | ||
PROCEDURAL PAIN | 3/1322 (0.2%) | 3/686 (0.4%) | ||
PROCEDURAL VOMITING | 3/1322 (0.2%) | 0/686 (0%) | ||
RADIUS FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
RESPIRATORY FUME INHALATION DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
RIB FRACTURE | 4/1322 (0.3%) | 3/686 (0.4%) | ||
ROAD TRAFFIC ACCIDENT | 10/1322 (0.8%) | 2/686 (0.3%) | ||
SCAPULA FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
SEROMA | 1/1322 (0.1%) | 0/686 (0%) | ||
SKULL FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
SNAKE BITE | 1/1322 (0.1%) | 0/686 (0%) | ||
SOFT TISSUE INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
SPINAL COMPRESSION FRACTURE | 6/1322 (0.5%) | 2/686 (0.3%) | ||
SPINAL FRACTURE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
SPLENIC RUPTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
STERNAL FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
SUBDURAL HAEMATOMA | 6/1322 (0.5%) | 4/686 (0.6%) | ||
SUTURE RELATED COMPLICATION | 0/1322 (0%) | 1/686 (0.1%) | ||
TENDON INJURY | 0/1322 (0%) | 2/686 (0.3%) | ||
TENDON RUPTURE | 1/1322 (0.1%) | 2/686 (0.3%) | ||
THERMAL BURN | 1/1322 (0.1%) | 0/686 (0%) | ||
THORACIC VERTEBRAL FRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
TIBIA FRACTURE | 0/1322 (0%) | 4/686 (0.6%) | ||
TOXICITY TO VARIOUS AGENTS | 0/1322 (0%) | 1/686 (0.1%) | ||
TRAUMATIC HAEMATOMA | 5/1322 (0.4%) | 2/686 (0.3%) | ||
TRAUMATIC HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
ULNA FRACTURE | 0/1322 (0%) | 1/686 (0.1%) | ||
UPPER LIMB FRACTURE | 4/1322 (0.3%) | 0/686 (0%) | ||
URINARY RETENTION POSTOPERATIVE | 5/1322 (0.4%) | 1/686 (0.1%) | ||
VASCULAR ACCESS COMPLICATION | 1/1322 (0.1%) | 0/686 (0%) | ||
VASCULAR GRAFT OCCLUSION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
VASCULAR PSEUDOANEURYSM | 10/1322 (0.8%) | 6/686 (0.9%) | ||
WOUND | 1/1322 (0.1%) | 0/686 (0%) | ||
WOUND EVISCERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
WOUND HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
WRIST FRACTURE | 3/1322 (0.2%) | 1/686 (0.1%) | ||
Investigations | ||||
ALANINE AMINOTRANSFERASE INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
ANGIOGRAM | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTERIOGRAM CORONARY ABNORMAL | 1/1322 (0.1%) | 2/686 (0.3%) | ||
BIOPSY LUNG | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD ALKALINE PHOSPHATASE INCREASED | 3/1322 (0.2%) | 0/686 (0%) | ||
BLOOD CREATINE INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD CREATINE PHOSPHOKINASE INCREASED | 12/1322 (0.9%) | 8/686 (1.2%) | ||
BLOOD CREATINE PHOSPHOKINASE MB INCREASED | 153/1322 (11.6%) | 72/686 (10.5%) | ||
BLOOD CREATININE INCREASED | 5/1322 (0.4%) | 2/686 (0.3%) | ||
BLOOD GLUCOSE DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD GLUCOSE INCREASED | 4/1322 (0.3%) | 1/686 (0.1%) | ||
BLOOD HOMOCYSTEINE INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD IRON DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD MAGNESIUM DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD POTASSIUM DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD PRESSURE DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD PRESSURE INCREASED | 12/1322 (0.9%) | 4/686 (0.6%) | ||
BLOOD PRESSURE ORTHOSTATIC ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD PRESSURE SYSTOLIC INCREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD TESTOSTERONE DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD THYROID STIMULATING HORMONE DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD TRIGLYCERIDES INCREASED | 3/1322 (0.2%) | 0/686 (0%) | ||
BLOOD URIC ACID INCREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD URINE PRESENT | 1/1322 (0.1%) | 0/686 (0%) | ||
BONE DENSITY ABNORMAL | 0/1322 (0%) | 1/686 (0.1%) | ||
BREATH SOUNDS ABNORMAL | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC ENZYMES INCREASED | 104/1322 (7.9%) | 45/686 (6.6%) | ||
CARDIAC MURMUR | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIAC STRESS TEST ABNORMAL | 9/1322 (0.7%) | 3/686 (0.4%) | ||
CAROTID BRUIT | 7/1322 (0.5%) | 3/686 (0.4%) | ||
CATHETERISATION CARDIAC | 0/1322 (0%) | 1/686 (0.1%) | ||
CLOSTRIDIUM TEST POSITIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
COMPUTERISED TOMOGRAM ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
COMPUTERISED TOMOGRAM THORAX ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
ECHOCARDIOGRAM ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
EJECTION FRACTION ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
EJECTION FRACTION DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
ELECTROCARDIOGRAM ABNORMAL | 0/1322 (0%) | 1/686 (0.1%) | ||
ELECTROCARDIOGRAM CHANGE | 4/1322 (0.3%) | 1/686 (0.1%) | ||
ELECTROCARDIOGRAM QT PROLONGED | 0/1322 (0%) | 1/686 (0.1%) | ||
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL | 0/1322 (0%) | 1/686 (0.1%) | ||
ELECTROCARDIOGRAM ST SEGMENT ELEVATION | 8/1322 (0.6%) | 0/686 (0%) | ||
ELECTROCARDIOGRAM ST-T CHANGE | 1/1322 (0.1%) | 0/686 (0%) | ||
FEMORAL BRUIT | 0/1322 (0%) | 1/686 (0.1%) | ||
GLOMERULAR FILTRATION RATE DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
GLYCOSYLATED HAEMOGLOBIN INCREASED | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HAEMOGLOBIN DECREASED | 3/1322 (0.2%) | 0/686 (0%) | ||
HEART RATE DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
HEART RATE INCREASED | 4/1322 (0.3%) | 0/686 (0%) | ||
HEART RATE IRREGULAR | 1/1322 (0.1%) | 2/686 (0.3%) | ||
HELICOBACTER TEST POSITIVE | 0/1322 (0%) | 1/686 (0.1%) | ||
HEPATIC ENZYME INCREASED | 4/1322 (0.3%) | 1/686 (0.1%) | ||
LIPIDS ABNORMAL | 0/1322 (0%) | 1/686 (0.1%) | ||
LIVER FUNCTION TEST ABNORMAL | 2/1322 (0.2%) | 4/686 (0.6%) | ||
METABOLIC FUNCTION TEST ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
OCCULT BLOOD POSITIVE | 2/1322 (0.2%) | 0/686 (0%) | ||
OXYGEN CONSUMPTION INCREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
PROSTATIC SPECIFIC ANTIGEN INCREASED | 2/1322 (0.2%) | 0/686 (0%) | ||
RED BLOOD CELL COUNT DECREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
RED BLOOD CELL SEDIMENTATION RATE INCREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
RENAL FUNCTION TEST ABNORMAL | 2/1322 (0.2%) | 0/686 (0%) | ||
THYROID FUNCTION TEST ABNORMAL | 1/1322 (0.1%) | 0/686 (0%) | ||
TROPONIN I INCREASED | 24/1322 (1.8%) | 10/686 (1.5%) | ||
TROPONIN INCREASED | 50/1322 (3.8%) | 20/686 (2.9%) | ||
TROPONIN T INCREASED | 0/1322 (0%) | 1/686 (0.1%) | ||
URINE LEUKOCYTE ESTERASE POSITIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
VITAMIN B12 DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
VITAMIN D DECREASED | 1/1322 (0.1%) | 1/686 (0.1%) | ||
WEIGHT DECREASED | 3/1322 (0.2%) | 1/686 (0.1%) | ||
WEIGHT INCREASED | 4/1322 (0.3%) | 0/686 (0%) | ||
WHITE BLOOD CELL COUNT INCREASED | 2/1322 (0.2%) | 0/686 (0%) | ||
Metabolism and nutrition disorders | ||||
DECREASED APPETITE | 1/1322 (0.1%) | 0/686 (0%) | ||
DEHYDRATION | 11/1322 (0.8%) | 11/686 (1.6%) | ||
DIABETES MELLITUS | 9/1322 (0.7%) | 3/686 (0.4%) | ||
DIABETES MELLITUS INADEQUATE CONTROL | 1/1322 (0.1%) | 0/686 (0%) | ||
DIABETIC KETOACIDOSIS | 5/1322 (0.4%) | 1/686 (0.1%) | ||
FAILURE TO THRIVE | 1/1322 (0.1%) | 0/686 (0%) | ||
FLUID OVERLOAD | 2/1322 (0.2%) | 2/686 (0.3%) | ||
FLUID RETENTION | 1/1322 (0.1%) | 0/686 (0%) | ||
GOUT | 5/1322 (0.4%) | 2/686 (0.3%) | ||
HYPERGLYCAEMIA | 14/1322 (1.1%) | 7/686 (1%) | ||
HYPERKALAEMIA | 4/1322 (0.3%) | 5/686 (0.7%) | ||
HYPERLIPIDAEMIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HYPERURICAEMIA | 2/1322 (0.2%) | 0/686 (0%) | ||
HYPOALBUMINAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPOCALCAEMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPOGLYCAEMIA | 10/1322 (0.8%) | 3/686 (0.4%) | ||
HYPOKALAEMIA | 15/1322 (1.1%) | 11/686 (1.6%) | ||
HYPOMAGNESAEMIA | 5/1322 (0.4%) | 3/686 (0.4%) | ||
HYPONATRAEMIA | 8/1322 (0.6%) | 5/686 (0.7%) | ||
HYPOVOLAEMIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
IMPAIRED FASTING GLUCOSE | 1/1322 (0.1%) | 0/686 (0%) | ||
LACTIC ACIDOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
METABOLIC ACIDOSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OBESITY | 6/1322 (0.5%) | 3/686 (0.4%) | ||
TYPE 2 DIABETES MELLITUS | 5/1322 (0.4%) | 4/686 (0.6%) | ||
VITAMIN B COMPLEX DEFICIENCY | 1/1322 (0.1%) | 0/686 (0%) | ||
VITAMIN D DEFICIENCY | 0/1322 (0%) | 2/686 (0.3%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 27/1322 (2%) | 16/686 (2.3%) | ||
ARTHRITIS | 8/1322 (0.6%) | 5/686 (0.7%) | ||
ARTHROFIBROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
BACK PAIN | 55/1322 (4.2%) | 28/686 (4.1%) | ||
BONE LESION | 0/1322 (0%) | 1/686 (0.1%) | ||
BONE PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
BURSITIS | 4/1322 (0.3%) | 4/686 (0.6%) | ||
CERVICAL SPINAL STENOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
CHONDROCALCINOSIS PYROPHOSPHATE | 1/1322 (0.1%) | 0/686 (0%) | ||
COSTOCHONDRITIS | 6/1322 (0.5%) | 1/686 (0.1%) | ||
DUPUYTREN'S CONTRACTURE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
EXOSTOSIS | 0/1322 (0%) | 2/686 (0.3%) | ||
FLANK PAIN | 1/1322 (0.1%) | 3/686 (0.4%) | ||
FOOT DEFORMITY | 0/1322 (0%) | 1/686 (0.1%) | ||
FRACTURE NONUNION | 1/1322 (0.1%) | 0/686 (0%) | ||
INTERVERTEBRAL DISC DEGENERATION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
INTERVERTEBRAL DISC PROTRUSION | 9/1322 (0.7%) | 2/686 (0.3%) | ||
JOINT EFFUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
JOINT STIFFNESS | 1/1322 (0.1%) | 0/686 (0%) | ||
JOINT SWELLING | 4/1322 (0.3%) | 1/686 (0.1%) | ||
LIMB DISCOMFORT | 3/1322 (0.2%) | 2/686 (0.3%) | ||
LUMBAR SPINAL STENOSIS | 7/1322 (0.5%) | 2/686 (0.3%) | ||
MOBILITY DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
MUSCLE SPASMS | 10/1322 (0.8%) | 1/686 (0.1%) | ||
MUSCULAR WEAKNESS | 6/1322 (0.5%) | 4/686 (0.6%) | ||
MUSCULOSKELETAL CHEST PAIN | 21/1322 (1.6%) | 7/686 (1%) | ||
MUSCULOSKELETAL DISCOMFORT | 5/1322 (0.4%) | 2/686 (0.3%) | ||
MUSCULOSKELETAL DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
MUSCULOSKELETAL PAIN | 18/1322 (1.4%) | 16/686 (2.3%) | ||
MYALGIA | 12/1322 (0.9%) | 8/686 (1.2%) | ||
MYOSITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
NECK PAIN | 7/1322 (0.5%) | 5/686 (0.7%) | ||
OSTEOARTHRITIS | 30/1322 (2.3%) | 18/686 (2.6%) | ||
OSTEOPENIA | 1/1322 (0.1%) | 0/686 (0%) | ||
OSTEOPOROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PAIN IN EXTREMITY | 40/1322 (3%) | 15/686 (2.2%) | ||
PAIN IN JAW | 7/1322 (0.5%) | 1/686 (0.1%) | ||
PERIARTHRITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PLANTAR FASCIITIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
POLYMYALGIA RHEUMATICA | 0/1322 (0%) | 2/686 (0.3%) | ||
RHABDOMYOLYSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
RHEUMATOID ARTHRITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
ROTATOR CUFF SYNDROME | 8/1322 (0.6%) | 4/686 (0.6%) | ||
SACROILIITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
SPINAL OSTEOARTHRITIS | 6/1322 (0.5%) | 4/686 (0.6%) | ||
SPONDYLITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
SPONDYLOLISTHESIS | 3/1322 (0.2%) | 2/686 (0.3%) | ||
SYNOVIAL CYST | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SYSTEMIC LUPUS ERYTHEMATOSUS | 0/1322 (0%) | 1/686 (0.1%) | ||
TENDINOUS CONTRACTURE | 1/1322 (0.1%) | 0/686 (0%) | ||
TENDONITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
TENOSYNOVITIS STENOSANS | 0/1322 (0%) | 1/686 (0.1%) | ||
TRIGGER FINGER | 1/1322 (0.1%) | 0/686 (0%) | ||
VERTEBRAL FORAMINAL STENOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
ACOUSTIC NEUROMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ACUTE MYELOID LEUKAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
ACUTE MYELOID LEUKAEMIA RECURRENT | 1/1322 (0.1%) | 0/686 (0%) | ||
ADENOCARCINOMA | 2/1322 (0.2%) | 1/686 (0.1%) | ||
ADENOCARCINOMA PANCREAS | 1/1322 (0.1%) | 0/686 (0%) | ||
B-CELL LYMPHOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
B-CELL LYMPHOMA STAGE IV | 1/1322 (0.1%) | 0/686 (0%) | ||
BASAL CELL CARCINOMA | 6/1322 (0.5%) | 7/686 (1%) | ||
BENIGN BREAST NEOPLASM | 0/1322 (0%) | 1/686 (0.1%) | ||
BENIGN OVARIAN TUMOUR | 1/1322 (0.1%) | 0/686 (0%) | ||
BILE DUCT CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
BLADDER CANCER | 3/1322 (0.2%) | 1/686 (0.1%) | ||
BLADDER CANCER RECURRENT | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BLADDER CANCER STAGE IV | 1/1322 (0.1%) | 0/686 (0%) | ||
BLADDER NEOPLASM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BRAIN NEOPLASM | 0/1322 (0%) | 1/686 (0.1%) | ||
BREAST CANCER | 5/1322 (0.4%) | 0/686 (0%) | ||
BREAST CANCER STAGE III | 1/1322 (0.1%) | 0/686 (0%) | ||
CERVIX CARCINOMA | 0/1322 (0%) | 1/686 (0.1%) | ||
CHRONIC LYMPHOCYTIC LEUKAEMIA | 0/1322 (0%) | 1/686 (0.1%) | ||
COLON ADENOMA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
COLON CANCER | 3/1322 (0.2%) | 2/686 (0.3%) | ||
DIFFUSE LARGE B-CELL LYMPHOMA | 2/1322 (0.2%) | 0/686 (0%) | ||
GASTRIC CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
GLIOBLASTOMA | 0/1322 (0%) | 2/686 (0.3%) | ||
HAEMANGIOMA OF SPLEEN | 0/1322 (0%) | 1/686 (0.1%) | ||
HEAD AND NECK CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
HEAD AND NECK CANCER METASTATIC | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC CANCER METASTATIC | 0/1322 (0%) | 1/686 (0.1%) | ||
HEPATIC NEOPLASM MALIGNANT | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPOPHARYNGEAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
LARYNGEAL CANCER | 0/1322 (0%) | 1/686 (0.1%) | ||
LEUKAEMIA | 1/1322 (0.1%) | 0/686 (0%) | ||
LEUKAEMIA RECURRENT | 1/1322 (0.1%) | 0/686 (0%) | ||
LIP AND/OR ORAL CAVITY CANCER | 0/1322 (0%) | 1/686 (0.1%) | ||
LIPOMA | 2/1322 (0.2%) | 0/686 (0%) | ||
LUNG ADENOCARCINOMA | 3/1322 (0.2%) | 0/686 (0%) | ||
LUNG CANCER METASTATIC | 1/1322 (0.1%) | 2/686 (0.3%) | ||
LUNG NEOPLASM | 5/1322 (0.4%) | 6/686 (0.9%) | ||
LUNG NEOPLASM MALIGNANT | 7/1322 (0.5%) | 0/686 (0%) | ||
LUNG SQUAMOUS CELL CARCINOMA STAGE III | 1/1322 (0.1%) | 0/686 (0%) | ||
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED | 2/1322 (0.2%) | 0/686 (0%) | ||
LYMPHOMA | 4/1322 (0.3%) | 0/686 (0%) | ||
MALIGNANT MELANOMA | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MELANOCYTIC NAEVUS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MENINGIOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LIVER | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LUNG | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO LYMPH NODES | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTASES TO SPINE | 1/1322 (0.1%) | 0/686 (0%) | ||
METASTATIC MALIGNANT MELANOMA | 3/1322 (0.2%) | 0/686 (0%) | ||
METASTATIC NEOPLASM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
MULTIPLE MYELOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
NEOPLASM MALIGNANT | 2/1322 (0.2%) | 0/686 (0%) | ||
NEURILEMMOMA MALIGNANT | 1/1322 (0.1%) | 0/686 (0%) | ||
NON-HODGKIN'S LYMPHOMA | 0/1322 (0%) | 1/686 (0.1%) | ||
NON-SMALL CELL LUNG CANCER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
OESOPHAGEAL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
ORAL NEOPLASM | 0/1322 (0%) | 1/686 (0.1%) | ||
OROPHARYNGEAL CANCER STAGE UNSPECIFIED | 0/1322 (0%) | 1/686 (0.1%) | ||
OVARIAN CANCER METASTATIC | 1/1322 (0.1%) | 0/686 (0%) | ||
OVARIAN EPITHELIAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
PANCREATIC CARCINOMA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PERICARDIAL EFFUSION MALIGNANT | 1/1322 (0.1%) | 0/686 (0%) | ||
PROSTATE CANCER | 11/1322 (0.8%) | 4/686 (0.6%) | ||
PROSTATE CANCER RECURRENT | 1/1322 (0.1%) | 0/686 (0%) | ||
RECTAL CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL CANCER | 0/1322 (0%) | 1/686 (0.1%) | ||
RENAL CELL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL HAEMANGIOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL NEOPLASM | 1/1322 (0.1%) | 0/686 (0%) | ||
SEBORRHOEIC KERATOSIS | 2/1322 (0.2%) | 0/686 (0%) | ||
SINONASAL PAPILLOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
SKIN CANCER | 3/1322 (0.2%) | 0/686 (0%) | ||
SKIN PAPILLOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
SMALL CELL LUNG CANCER LIMITED STAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
SMALL CELL LUNG CANCER STAGE UNSPECIFIED | 1/1322 (0.1%) | 0/686 (0%) | ||
SQUAMOUS CELL CARCINOMA | 5/1322 (0.4%) | 3/686 (0.4%) | ||
SQUAMOUS CELL CARCINOMA OF SKIN | 0/1322 (0%) | 1/686 (0.1%) | ||
THYROID NEOPLASM | 1/1322 (0.1%) | 2/686 (0.3%) | ||
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | 1/1322 (0.1%) | 0/686 (0%) | ||
TRANSITIONAL CELL CARCINOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
URETERIC CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
UTERINE CANCER | 1/1322 (0.1%) | 0/686 (0%) | ||
UTERINE LEIOMYOMA | 0/1322 (0%) | 1/686 (0.1%) | ||
VULVAL CANCER STAGE 0 | 1/1322 (0.1%) | 0/686 (0%) | ||
Nervous system disorders | ||||
ALTERED STATE OF CONSCIOUSNESS | 1/1322 (0.1%) | 0/686 (0%) | ||
AMNESIA | 4/1322 (0.3%) | 2/686 (0.3%) | ||
APHASIA | 0/1322 (0%) | 1/686 (0.1%) | ||
ARACHNOIDITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
ATAXIA | 1/1322 (0.1%) | 0/686 (0%) | ||
AUTONOMIC NERVOUS SYSTEM IMBALANCE | 1/1322 (0.1%) | 0/686 (0%) | ||
BALANCE DISORDER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
BURNING SENSATION | 1/1322 (0.1%) | 0/686 (0%) | ||
CAROTID ARTERY DISEASE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
CAROTID ARTERY STENOSIS | 15/1322 (1.1%) | 9/686 (1.3%) | ||
CARPAL TUNNEL SYNDROME | 4/1322 (0.3%) | 2/686 (0.3%) | ||
CAUDA EQUINA SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
CENTRAL NERVOUS SYSTEM LESION | 1/1322 (0.1%) | 0/686 (0%) | ||
CEREBELLAR INFARCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
CEREBRAL HAEMORRHAGE | 0/1322 (0%) | 1/686 (0.1%) | ||
CEREBRAL INFARCTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CEREBROVASCULAR ACCIDENT | 20/1322 (1.5%) | 15/686 (2.2%) | ||
CEREBROVASCULAR DISORDER | 1/1322 (0.1%) | 1/686 (0.1%) | ||
CERVICOBRACHIAL SYNDROME | 1/1322 (0.1%) | 1/686 (0.1%) | ||
COMPLICATED MIGRAINE | 2/1322 (0.2%) | 0/686 (0%) | ||
CONVULSION | 4/1322 (0.3%) | 2/686 (0.3%) | ||
CUBITAL TUNNEL SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
DEMENTIA | 0/1322 (0%) | 1/686 (0.1%) | ||
DIABETIC NEUROPATHY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DIZZINESS | 58/1322 (4.4%) | 27/686 (3.9%) | ||
DIZZINESS EXERTIONAL | 2/1322 (0.2%) | 0/686 (0%) | ||
DIZZINESS POSTURAL | 7/1322 (0.5%) | 0/686 (0%) | ||
DYSAESTHESIA | 1/1322 (0.1%) | 0/686 (0%) | ||
DYSARTHRIA | 4/1322 (0.3%) | 0/686 (0%) | ||
DYSGEUSIA | 1/1322 (0.1%) | 0/686 (0%) | ||
EMBOLIC STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
ENCEPHALOPATHY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ESSENTIAL TREMOR | 1/1322 (0.1%) | 0/686 (0%) | ||
GUILLAIN-BARRE SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMORRHAGE INTRACRANIAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HAEMORRHAGIC STROKE | 1/1322 (0.1%) | 0/686 (0%) | ||
HEAD DISCOMFORT | 1/1322 (0.1%) | 0/686 (0%) | ||
HEAD TITUBATION | 1/1322 (0.1%) | 0/686 (0%) | ||
HEADACHE | 28/1322 (2.1%) | 19/686 (2.8%) | ||
HEMIPARESIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HEMIPLEGIC MIGRAINE | 1/1322 (0.1%) | 0/686 (0%) | ||
HEPATIC ENCEPHALOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPOAESTHESIA | 13/1322 (1%) | 8/686 (1.2%) | ||
HYPOXIC-ISCHAEMIC ENCEPHALOPATHYv | 2/1322 (0.2%) | 0/686 (0%) | ||
IIIRD NERVE PARALYSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
INTENTION TREMOR | 0/1322 (0%) | 1/686 (0.1%) | ||
ISCHAEMIC STROKE | 6/1322 (0.5%) | 3/686 (0.4%) | ||
LACUNAR INFARCTION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
LATERAL MEDULLARY SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
LETHARGY | 2/1322 (0.2%) | 0/686 (0%) | ||
LOSS OF CONSCIOUSNESS | 2/1322 (0.2%) | 0/686 (0%) | ||
LUMBAR RADICULOPATHY | 2/1322 (0.2%) | 2/686 (0.3%) | ||
MEMORY IMPAIRMENT | 6/1322 (0.5%) | 0/686 (0%) | ||
MENTAL IMPAIRMENT | 1/1322 (0.1%) | 0/686 (0%) | ||
METABOLIC ENCEPHALOPATHY | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MIGRAINE | 3/1322 (0.2%) | 1/686 (0.1%) | ||
MYELOMALACIA | 1/1322 (0.1%) | 0/686 (0%) | ||
NERVE COMPRESSION | 1/1322 (0.1%) | 2/686 (0.3%) | ||
NEURALGIA | 0/1322 (0%) | 1/686 (0.1%) | ||
NEUROLOGICAL SYMPTOM | 1/1322 (0.1%) | 2/686 (0.3%) | ||
NEUROPATHY PERIPHERAL | 1/1322 (0.1%) | 0/686 (0%) | ||
NYSTAGMUS | 2/1322 (0.2%) | 0/686 (0%) | ||
PARAESTHESIA | 8/1322 (0.6%) | 4/686 (0.6%) | ||
POLYNEUROPATHY ALCOHOLIC | 1/1322 (0.1%) | 0/686 (0%) | ||
POST-TRAUMATIC HEADACHE | 0/1322 (0%) | 2/686 (0.3%) | ||
PRESYNCOPE | 26/1322 (2%) | 8/686 (1.2%) | ||
RADICULITIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
RADICULITIS CERVICAL | 1/1322 (0.1%) | 0/686 (0%) | ||
SCIATICA | 4/1322 (0.3%) | 2/686 (0.3%) | ||
SENSORY DISTURBANCE | 1/1322 (0.1%) | 0/686 (0%) | ||
SOMNOLENCE | 3/1322 (0.2%) | 0/686 (0%) | ||
SPEECH DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
SPONDYLITIC MYELOPATHY | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBARACHNOID HAEMORRHAGE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SUBDURAL HYGROMA | 2/1322 (0.2%) | 0/686 (0%) | ||
SYNCOPE | 40/1322 (3%) | 22/686 (3.2%) | ||
THALAMIC INFARCTION | 3/1322 (0.2%) | 0/686 (0%) | ||
THROMBOTIC STROKE | 0/1322 (0%) | 1/686 (0.1%) | ||
TRANSIENT GLOBAL AMNESIA | 2/1322 (0.2%) | 0/686 (0%) | ||
TRANSIENT ISCHAEMIC ATTACK | 17/1322 (1.3%) | 8/686 (1.2%) | ||
TREMOR | 4/1322 (0.3%) | 2/686 (0.3%) | ||
UNRESPONSIVE TO STIMULI | 1/1322 (0.1%) | 0/686 (0%) | ||
URAEMIC ENCEPHALOPATHY | 0/1322 (0%) | 1/686 (0.1%) | ||
VERTEBRAL ARTERY OCCLUSION | 0/1322 (0%) | 1/686 (0.1%) | ||
VITH NERVE PARALYSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
Psychiatric disorders | ||||
ACUTE STRESS DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT | 0/1322 (0%) | 1/686 (0.1%) | ||
AFFECTIVE DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
ALCOHOL ABUSE | 1/1322 (0.1%) | 1/686 (0.1%) | ||
ALCOHOL PROBLEM | 1/1322 (0.1%) | 0/686 (0%) | ||
ALCOHOL WITHDRAWAL SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
ANXIETY | 20/1322 (1.5%) | 7/686 (1%) | ||
ANXIETY DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
BIPOLAR DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
BIPOLAR I DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
COMPLETED SUICIDE | 0/1322 (0%) | 1/686 (0.1%) | ||
CONFUSIONAL STATE | 4/1322 (0.3%) | 2/686 (0.3%) | ||
DELIRIUM | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DELIRIUM TREMENS | 0/1322 (0%) | 1/686 (0.1%) | ||
DEPRESSED MOOD | 1/1322 (0.1%) | 0/686 (0%) | ||
DEPRESSION | 17/1322 (1.3%) | 3/686 (0.4%) | ||
DEPRESSION SUICIDAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
HALLUCINATION | 0/1322 (0%) | 1/686 (0.1%) | ||
HALLUCINATION, VISUAL | 0/1322 (0%) | 1/686 (0.1%) | ||
INSOMNIA | 4/1322 (0.3%) | 3/686 (0.4%) | ||
INTENTIONAL SELF-INJURY | 1/1322 (0.1%) | 0/686 (0%) | ||
MAJOR DEPRESSION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
MENTAL STATUS CHANGES | 6/1322 (0.5%) | 2/686 (0.3%) | ||
OBSESSIVE-COMPULSIVE DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
PANIC ATTACK | 2/1322 (0.2%) | 1/686 (0.1%) | ||
STRESS | 1/1322 (0.1%) | 0/686 (0%) | ||
SUICIDAL IDEATION | 0/1322 (0%) | 2/686 (0.3%) | ||
Renal and urinary disorders | ||||
BLADDER DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
CALCULUS URETERIC | 1/1322 (0.1%) | 3/686 (0.4%) | ||
CYSTITIS HAEMORRHAGIC | 2/1322 (0.2%) | 0/686 (0%) | ||
CYSTITIS INTERSTITIAL | 1/1322 (0.1%) | 0/686 (0%) | ||
DYSURIA | 4/1322 (0.3%) | 0/686 (0%) | ||
HAEMATURIA | 13/1322 (1%) | 11/686 (1.6%) | ||
HYDRONEPHROSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
HYPERTONIC BLADDER | 1/1322 (0.1%) | 0/686 (0%) | ||
MICROALBUMINURIA | 1/1322 (0.1%) | 0/686 (0%) | ||
NEPHROLITHIASIS | 18/1322 (1.4%) | 10/686 (1.5%) | ||
NOCTURIA | 1/1322 (0.1%) | 0/686 (0%) | ||
POLLAKIURIA | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL ARTERY STENOSIS | 1/1322 (0.1%) | 3/686 (0.4%) | ||
RENAL CYST | 4/1322 (0.3%) | 2/686 (0.3%) | ||
RENAL DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
RENAL FAILURE | 8/1322 (0.6%) | 5/686 (0.7%) | ||
RENAL FAILURE ACUTE | 17/1322 (1.3%) | 14/686 (2%) | ||
RENAL FAILURE CHRONIC | 3/1322 (0.2%) | 5/686 (0.7%) | ||
RENAL IMPAIRMENT | 1/1322 (0.1%) | 2/686 (0.3%) | ||
RENAL TUBULAR NECROSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
STRESS URINARY INCONTINENCE | 1/1322 (0.1%) | 0/686 (0%) | ||
URETHRAL STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
URINARY HESITATION | 1/1322 (0.1%) | 0/686 (0%) | ||
URINARY INCONTINENCE | 2/1322 (0.2%) | 0/686 (0%) | ||
URINARY RETENTION | 12/1322 (0.9%) | 3/686 (0.4%) | ||
URINE FLOW DECREASED | 1/1322 (0.1%) | 0/686 (0%) | ||
Reproductive system and breast disorders | ||||
BENIGN PROSTATIC HYPERPLASIA | 7/1322 (0.5%) | 5/686 (0.7%) | ||
BREAST CALCIFICATIONS | 1/1322 (0.1%) | 0/686 (0%) | ||
BREAST MASS | 2/1322 (0.2%) | 0/686 (0%) | ||
BREAST PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
DYSFUNCTIONAL UTERINE BLEEDING | 1/1322 (0.1%) | 0/686 (0%) | ||
EPIDIDYMAL CYST | 0/1322 (0%) | 1/686 (0.1%) | ||
FALLOPIAN TUBE CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
FEMALE GENITAL TRACT FISTULA | 1/1322 (0.1%) | 0/686 (0%) | ||
HAEMATOSPERMIA | 3/1322 (0.2%) | 0/686 (0%) | ||
MENORRHAGIA | 0/1322 (0%) | 2/686 (0.3%) | ||
PELVIC HAEMATOMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PENILE HAEMORRHAGE | 2/1322 (0.2%) | 0/686 (0%) | ||
POLYCYSTIC OVARIES | 1/1322 (0.1%) | 0/686 (0%) | ||
PROSTATITIS | 2/1322 (0.2%) | 0/686 (0%) | ||
PROSTATOMEGALY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
SEXUAL DYSFUNCTION | 1/1322 (0.1%) | 0/686 (0%) | ||
SPERMATOCELE | 1/1322 (0.1%) | 0/686 (0%) | ||
TESTICULAR PAIN | 1/1322 (0.1%) | 0/686 (0%) | ||
UTERINE POLYP | 1/1322 (0.1%) | 0/686 (0%) | ||
VAGINAL HAEMORRHAGE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
VULVA CYST | 1/1322 (0.1%) | 0/686 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE PULMONARY OEDEMA | 0/1322 (0%) | 4/686 (0.6%) | ||
ACUTE RESPIRATORY FAILURE | 18/1322 (1.4%) | 7/686 (1%) | ||
ALLERGIC GRANULOMATOUS ANGIITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
ASPIRATION | 1/1322 (0.1%) | 0/686 (0%) | ||
ASTHMA | 6/1322 (0.5%) | 4/686 (0.6%) | ||
ATELECTASIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
BRONCHIAL HYPERREACTIVITY | 0/1322 (0%) | 1/686 (0.1%) | ||
BRONCHITIS CHRONIC | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOKING | 1/1322 (0.1%) | 0/686 (0%) | ||
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 35/1322 (2.6%) | 15/686 (2.2%) | ||
COUGH | 21/1322 (1.6%) | 12/686 (1.7%) | ||
DYSPHONIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
DYSPNOEA | 126/1322 (9.5%) | 55/686 (8%) | ||
DYSPNOEA EXERTIONAL | 51/1322 (3.9%) | 33/686 (4.8%) | ||
DYSPNOEA PAROXYSMAL NOCTURNAL | 0/1322 (0%) | 1/686 (0.1%) | ||
EMPHYSEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
EPISTAXIS | 26/1322 (2%) | 15/686 (2.2%) | ||
HAEMOPTYSIS | 2/1322 (0.2%) | 5/686 (0.7%) | ||
HYPERVENTILATION | 0/1322 (0%) | 1/686 (0.1%) | ||
HYPOXIA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
INTERSTITIAL LUNG DISEASE | 1/1322 (0.1%) | 0/686 (0%) | ||
MEDIASTINAL MASS | 0/1322 (0%) | 1/686 (0.1%) | ||
NASAL POLYPS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
NASAL SEPTUM ULCERATION | 0/1322 (0%) | 1/686 (0.1%) | ||
NON-CARDIOGENIC PULMONARY OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
OBSTRUCTIVE AIRWAYS DISORDER | 0/1322 (0%) | 1/686 (0.1%) | ||
ORGANISING PNEUMONIA | 0/1322 (0%) | 1/686 (0.1%) | ||
OROPHARYNGEAL PAIN | 4/1322 (0.3%) | 3/686 (0.4%) | ||
ORTHOPNOEA | 3/1322 (0.2%) | 0/686 (0%) | ||
PHARYNGEAL OEDEMA | 1/1322 (0.1%) | 0/686 (0%) | ||
PLEURAL EFFUSION | 9/1322 (0.7%) | 6/686 (0.9%) | ||
PLEURITIC PAIN | 4/1322 (0.3%) | 2/686 (0.3%) | ||
PNEUMONIA ASPIRATION | 0/1322 (0%) | 4/686 (0.6%) | ||
PNEUMONITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
PNEUMOTHORAX | 2/1322 (0.2%) | 6/686 (0.9%) | ||
PRODUCTIVE COUGH | 0/1322 (0%) | 1/686 (0.1%) | ||
PULMONARY CONGESTION | 0/1322 (0%) | 1/686 (0.1%) | ||
PULMONARY EMBOLISM | 9/1322 (0.7%) | 7/686 (1%) | ||
PULMONARY FIBROSIS | 0/1322 (0%) | 2/686 (0.3%) | ||
PULMONARY HYPERTENSION | 1/1322 (0.1%) | 0/686 (0%) | ||
PULMONARY OEDEMA | 3/1322 (0.2%) | 2/686 (0.3%) | ||
RESPIRATORY ALKALOSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
RESPIRATORY ARREST | 2/1322 (0.2%) | 0/686 (0%) | ||
RESPIRATORY DISORDER | 1/1322 (0.1%) | 0/686 (0%) | ||
RESPIRATORY FAILURE | 14/1322 (1.1%) | 8/686 (1.2%) | ||
RHINITIS ALLERGIC | 3/1322 (0.2%) | 0/686 (0%) | ||
RHINORRHOEA | 1/1322 (0.1%) | 0/686 (0%) | ||
SINUS CONGESTION | 2/1322 (0.2%) | 1/686 (0.1%) | ||
SLEEP APNOEA SYNDROME | 8/1322 (0.6%) | 6/686 (0.9%) | ||
THROAT TIGHTNESS | 2/1322 (0.2%) | 0/686 (0%) | ||
TRACHEAL STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
UPPER RESPIRATORY TRACT CONGESTION | 1/1322 (0.1%) | 0/686 (0%) | ||
UPPER-AIRWAY COUGH SYNDROME | 0/1322 (0%) | 1/686 (0.1%) | ||
WHEEZING | 2/1322 (0.2%) | 0/686 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
ACTINIC KERATOSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
ANGIOEDEMA | 2/1322 (0.2%) | 1/686 (0.1%) | ||
DECUBITUS ULCER | 3/1322 (0.2%) | 1/686 (0.1%) | ||
DERMATITIS | 0/1322 (0%) | 1/686 (0.1%) | ||
DERMATITIS ATOPIC | 1/1322 (0.1%) | 0/686 (0%) | ||
DERMATITIS CONTACT | 2/1322 (0.2%) | 0/686 (0%) | ||
DIABETIC FOOT | 3/1322 (0.2%) | 0/686 (0%) | ||
DRUG ERUPTION | 0/1322 (0%) | 2/686 (0.3%) | ||
ECCHYMOSIS | 3/1322 (0.2%) | 0/686 (0%) | ||
ECZEMA | 2/1322 (0.2%) | 0/686 (0%) | ||
ERYTHEMA | 2/1322 (0.2%) | 0/686 (0%) | ||
HYPERHIDROSIS | 5/1322 (0.4%) | 1/686 (0.1%) | ||
HYPERKERATOSIS | 0/1322 (0%) | 2/686 (0.3%) | ||
INCREASED TENDENCY TO BRUISE | 9/1322 (0.7%) | 5/686 (0.7%) | ||
INGROWING NAIL | 0/1322 (0%) | 1/686 (0.1%) | ||
LICHENOID KERATOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
LIVEDO RETICULARIS | 1/1322 (0.1%) | 0/686 (0%) | ||
NIGHT SWEATS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PRECANCEROUS SKIN LESION | 1/1322 (0.1%) | 0/686 (0%) | ||
PRURITUS | 4/1322 (0.3%) | 2/686 (0.3%) | ||
PRURITUS ALLERGIC | 0/1322 (0%) | 1/686 (0.1%) | ||
PSORIASIS | 1/1322 (0.1%) | 0/686 (0%) | ||
RASH | 15/1322 (1.1%) | 8/686 (1.2%) | ||
RASH GENERALISED | 2/1322 (0.2%) | 1/686 (0.1%) | ||
RASH PRURITIC | 2/1322 (0.2%) | 1/686 (0.1%) | ||
SEBORRHOEIC DERMATITIS | 1/1322 (0.1%) | 0/686 (0%) | ||
SKIN LESION | 2/1322 (0.2%) | 0/686 (0%) | ||
SKIN ULCER | 5/1322 (0.4%) | 3/686 (0.4%) | ||
SWELLING FACE | 2/1322 (0.2%) | 0/686 (0%) | ||
URTICARIA | 4/1322 (0.3%) | 0/686 (0%) | ||
Surgical and medical procedures | ||||
AORTIC ANEURYSM REPAIR | 1/1322 (0.1%) | 0/686 (0%) | ||
CARDIAC ABLATION | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC PACEMAKER BATTERY REPLACEMENT | 0/1322 (0%) | 1/686 (0.1%) | ||
CARDIAC PACEMAKER REPLACEMENT | 1/1322 (0.1%) | 0/686 (0%) | ||
CHOLECYSTECTOMY | 1/1322 (0.1%) | 1/686 (0.1%) | ||
COLOSTOMY | 0/1322 (0%) | 1/686 (0.1%) | ||
CORONARY ARTERY BYPASS | 1/1322 (0.1%) | 0/686 (0%) | ||
DENTAL IMPLANTATION | 1/1322 (0.1%) | 0/686 (0%) | ||
HERNIA HIATUS REPAIR | 1/1322 (0.1%) | 0/686 (0%) | ||
HIP ARTHROPLASTY | 3/1322 (0.2%) | 0/686 (0%) | ||
INGUINAL HERNIA REPAIR | 0/1322 (0%) | 1/686 (0.1%) | ||
KNEE ARTHROPLASTY | 1/1322 (0.1%) | 0/686 (0%) | ||
LEG AMPUTATION | 0/1322 (0%) | 1/686 (0.1%) | ||
MEDICAL DEVICE REMOVAL | 0/1322 (0%) | 1/686 (0.1%) | ||
NEPHRECTOMY | 1/1322 (0.1%) | 0/686 (0%) | ||
SINUS OPERATION | 1/1322 (0.1%) | 0/686 (0%) | ||
SPINAL FUSION SURGERY | 1/1322 (0.1%) | 0/686 (0%) | ||
TENDON OPERATION | 0/1322 (0%) | 1/686 (0.1%) | ||
THERAPY CESSATION | 1/1322 (0.1%) | 0/686 (0%) | ||
TONSILLECTOMY | 0/1322 (0%) | 1/686 (0.1%) | ||
TOOTH EXTRACTION | 0/1322 (0%) | 1/686 (0.1%) | ||
TRANSURETHRAL PROSTATECTOMY | 0/1322 (0%) | 1/686 (0.1%) | ||
Vascular disorders | ||||
ACCELERATED HYPERTENSION | 4/1322 (0.3%) | 1/686 (0.1%) | ||
AORTIC ANEURYSM | 8/1322 (0.6%) | 3/686 (0.4%) | ||
AORTIC DISSECTION | 0/1322 (0%) | 1/686 (0.1%) | ||
AORTIC INTRAMURAL HAEMATOMA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
AORTIC STENOSIS | 4/1322 (0.3%) | 5/686 (0.7%) | ||
ARTERIAL SPASM | 1/1322 (0.1%) | 0/686 (0%) | ||
ARTERIOSCLEROSIS | 0/1322 (0%) | 1/686 (0.1%) | ||
ARTERIOVENOUS FISTULA | 1/1322 (0.1%) | 0/686 (0%) | ||
BLEEDING VARICOSE VEIN | 1/1322 (0.1%) | 0/686 (0%) | ||
BLOOD PRESSURE FLUCTUATION | 0/1322 (0%) | 1/686 (0.1%) | ||
BLOOD PRESSURE INADEQUATELY CONTROLLED | 1/1322 (0.1%) | 0/686 (0%) | ||
CIRCULATORY COLLAPSE | 0/1322 (0%) | 1/686 (0.1%) | ||
DEEP VEIN THROMBOSIS | 12/1322 (0.9%) | 8/686 (1.2%) | ||
ESSENTIAL HYPERTENSION | 1/1322 (0.1%) | 1/686 (0.1%) | ||
FEMORAL ARTERIAL STENOSIS | 2/1322 (0.2%) | 1/686 (0.1%) | ||
FEMORAL ARTERY OCCLUSION | 0/1322 (0%) | 1/686 (0.1%) | ||
FLUSHING | 0/1322 (0%) | 1/686 (0.1%) | ||
HAEMATOMA | 8/1322 (0.6%) | 1/686 (0.1%) | ||
HAEMORRHAGE | 2/1322 (0.2%) | 1/686 (0.1%) | ||
HOT FLUSH | 1/1322 (0.1%) | 0/686 (0%) | ||
HYPERTENSION | 60/1322 (4.5%) | 24/686 (3.5%) | ||
HYPERTENSIVE CRISIS | 7/1322 (0.5%) | 7/686 (1%) | ||
HYPOTENSION | 38/1322 (2.9%) | 13/686 (1.9%) | ||
ILIAC ARTERY OCCLUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
ILIAC ARTERY STENOSIS | 1/1322 (0.1%) | 1/686 (0.1%) | ||
INTERMITTENT CLAUDICATION | 14/1322 (1.1%) | 10/686 (1.5%) | ||
LABILE HYPERTENSION | 1/1322 (0.1%) | 0/686 (0%) | ||
MALIGNANT HYPERTENSION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORTHOSTATIC HYPERTENSION | 1/1322 (0.1%) | 0/686 (0%) | ||
ORTHOSTATIC HYPOTENSION | 8/1322 (0.6%) | 3/686 (0.4%) | ||
PALLOR | 1/1322 (0.1%) | 0/686 (0%) | ||
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 5/1322 (0.4%) | 10/686 (1.5%) | ||
PERIPHERAL COLDNESS | 2/1322 (0.2%) | 0/686 (0%) | ||
PERIPHERAL ISCHAEMIA | 1/1322 (0.1%) | 1/686 (0.1%) | ||
PERIPHERAL VASCULAR DISORDER | 8/1322 (0.6%) | 6/686 (0.9%) | ||
POOR PERIPHERAL CIRCULATION | 1/1322 (0.1%) | 0/686 (0%) | ||
RAYNAUD'S PHENOMENON | 1/1322 (0.1%) | 0/686 (0%) | ||
REPERFUSION INJURY | 5/1322 (0.4%) | 2/686 (0.3%) | ||
SUBCLAVIAN ARTERY OCCLUSION | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBCLAVIAN ARTERY STENOSIS | 1/1322 (0.1%) | 0/686 (0%) | ||
SUBCLAVIAN STEAL SYNDROME | 1/1322 (0.1%) | 0/686 (0%) | ||
THROMBOPHLEBITIS SUPERFICIAL | 1/1322 (0.1%) | 1/686 (0.1%) | ||
THROMBOSIS | 3/1322 (0.2%) | 0/686 (0%) | ||
VARICOSE VEIN | 1/1322 (0.1%) | 0/686 (0%) | ||
VASOSPASM | 1/1322 (0.1%) | 0/686 (0%) | ||
VENOUS INSUFFICIENCY | 1/1322 (0.1%) | 0/686 (0%) | ||
WEGENER'S GRANULOMATOSIS | 1/1322 (0.1%) | 0/686 (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 | Latania Chura / Project Manager |
---|---|
Organization | Abbott Vascular |
Phone | 503.935.3002 |
latania.chura@abbott.com |
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