Absorb IV Randomized Controlled Trial

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT02173379
Collaborator
(none)
2,604
120
2
93.8
21.7
0.2

Study Details

Study Description

Brief Summary

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Condition or Disease Intervention/Treatment Phase
  • Device: Absorb BVS
  • Device: XIENCE
N/A

Detailed Description

ABSORB IV:
A. Primary Objective:
  • To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

  • To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:
  • To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

  • To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.

Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
2604 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Apr 25, 2022
Actual Study Completion Date :
Apr 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Absorb BVS

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System

Device: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Active Comparator: XIENCE

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)

Device: XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition Stent lengths: 8, 12, 15, 18, 23, and 28 mm For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Target Lesion Failure (TLF) [30 days]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Secondary Outcome Measures

  1. TLF at 1-year, Non-inferiority Against the Control [1 year]

    One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.

  2. Angina at 1-year, Non-inferiority Against the Control [1 year]

    Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.

  3. Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) [In-hospital (≤ 7days)]

    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

  4. Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) [In-hospital (≤ 7days)]

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).

  5. Number of Death (Cardiac, Vascular, Non-cardiovascular) [In-hospital (≤ 7 days post index procedure)]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular) [30 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  7. Number of Death (Cardiac, Vascular, Non-cardiovascular) [90 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  8. Number of Death (Cardiac, Vascular, Non-cardiovascular) [180 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  9. Number of Death (Cardiac, Vascular, Non-cardiovascular) [270 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  10. Number of Death (Cardiac, Vascular, Non-cardiovascular) [1 year]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  11. Number of Death (Cardiac, Vascular, Non-cardiovascular) [2 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  12. Number of Death (Cardiac, Vascular, Non-cardiovascular) [5 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  13. Number of Participants With Myocardial Infarction (MI) [In-hospital (≤ 7 days post index procedure)]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  14. Number of Participants With Myocardial Infarction (MI) [30 days]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  15. Number of Participants With Myocardial Infarction (MI) [90 days]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  16. Number of Participants With Myocardial Infarction (MI) [180 days]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  17. Number of Participants With Myocardial Infarction (MI) [270 days]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  18. Number of Participants With Myocardial Infarction (MI) [1 year]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  19. Number of Participants With Myocardial Infarction (MI) [2 years]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  20. Number of Participants With Myocardial Infarction (MI) [3 years]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  21. Number of Participants With Myocardial Infarction (MI) [4 years]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  22. Number of Participants With Myocardial Infarction (MI) [5 years]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  23. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [In-hospital (≤ 7 days post index procedure)]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  24. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [30 days]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  25. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [90 days]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  26. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [180 days]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  27. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [270 days]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  28. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [1 year]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  29. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [2 year]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  30. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [3 years]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  31. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [4 years]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  32. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [5 years]

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  33. Number of Participants With Target Lesion Revascularization (TLR) [In-hospital (≤ 7 days post index procedure)]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  34. Number of Participants With Target Lesion Revascularization (TLR) [30 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  35. Number of Participants withTarget Lesion Revascularization (TLR) [90 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  36. Number of Participants With Target Lesion Revascularization (TLR) [180 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  37. Number of Participants With Target Lesion Revascularization (TLR) [270 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  38. Number of Participants With Target Lesion Revascularization (TLR) [1 year]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  39. Number of Participants With Target Lesion Revascularization (TLR) [2 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  40. Number of Participants With Target Lesion Revascularization (TLR) [3 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  41. Number of Participants With Target Lesion Revascularization (TLR) [4 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  42. Number of Participants With Target Lesion Revascularization (TLR) [5 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

  43. Number of Participants With Ischemia Driven TLR (ID-TLR) [In-hospital (≤ 7 days post index procedure)]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  44. Number of Participants With Ischemia Driven TLR (ID-TLR) [30 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  45. Number of Participants With Ischemia Driven TLR (ID-TLR) [90 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  46. Number of Participants With Ischemia Driven TLR (ID-TLR) [180 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  47. Number of Participants With Ischemia Driven TLR (ID-TLR) [270 days]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  48. Number of Participants With Ischemia Driven TLR (ID-TLR) [1 year]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  49. Number of Participants With Ischemia Driven TLR (ID-TLR) [2 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  50. Number of Participants With Ischemia Driven TLR (ID-TLR) [3 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  51. Number of Participants With Ischemia Driven TLR (ID-TLR) [4 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  52. Number of Participants With Ischemia Driven TLR (ID-TLR) [5 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

  53. Number of Participants With Target Vessel Revascularization (TVR) [In-hospital (≤ 7 days post index procedure)]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  54. Number of Participants With Target Vessel Revascularization (TVR) [30 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  55. Number of Participants With Target Vessel Revascularization (TVR) [90 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  56. Number of Participants With Target Vessel Revascularization (TVR) [180 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR

  57. Number of Participants With Target Vessel Revascularization (TVR) [270 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  58. Number of Participants With Target Vessel Revascularization (TVR) [1 year]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  59. Number of Participants With Target Vessel Revascularization (TVR) [2 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  60. Number of Participants With Target Vessel Revascularization (TVR) [3 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  61. Number of Participants With Target Vessel Revascularization (TVR) [4 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  62. Number of Participants With Target Vessel Revascularization (TVR) [5 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  63. Number of Participants With ID-TVR Excluding TLR [In-hospital (≤ 7 days post index procedure)]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  64. Number of Participants With ID-TVR Excluding TLR [30 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  65. Number of Participants With ID-TVR Excluding TLR [90 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  66. Number of Participants With ID-TVR Excluding TLR [180 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  67. Number of Participants With ID-TVR Excluding TLR [270 days]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  68. Number of Participants With ID-TVR Excluding TLR [1 year]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  69. Number of Participants With ID-TVR Excluding TLR [2 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  70. Number of Participants With ID-TVR Excluding TLR [3 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  71. Number of Participants With ID-TVR Excluding TLR [4 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  72. Number of Participants With ID-TVR Excluding TLR [5 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR

  73. Number of Participants With All Coronary Revascularization [In-hospital (≤ 7 days post index procedure)]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  74. Number of Participants With All Coronary Revascularization [30 days]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  75. Number of Participants With All Coronary Revascularization [90 days]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  76. Number of Participants With All Coronary Revascularization [180 days]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  77. Number of Participants With All Coronary Revascularization [270 days]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  78. Number of Participants With All Coronary Revascularization [1 year]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  79. Number of Participants With All Coronary Revascularization [2 years]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  80. Number of Participants With All Coronary Revascularization [3 years]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  81. Number of Participants With All Coronary Revascularization [4 years]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  82. Number of Participants With All Coronary Revascularization [5 years]

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  83. Number of Participants Experienced All Death/All MI [In-hospital (≤ 7 days post index procedure)]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  84. Number of Participants Experienced All Death/All MI [30 days]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  85. Number of Participants Experienced All Death/All MI [90 days]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  86. Number of Participants Experienced All Death/All MI [180 days]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  87. Number of Participants Experienced All Death/All MI [270 days]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  88. Number of Participants Experienced All Death/All MI [1 year]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  89. Number of Participants Experienced All Death/All MI [2 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  90. Number of Participants Experienced All Death/All MI [3 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  91. Number of Participants Experienced All Death/All MI [4 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  92. Number of Participants Experienced All Death/All MI [5 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  93. Number of Participants Experienced Cardiac Death/All MI [In-hospital (≤ 7 days post index procedure)]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  94. Number of Participants Experienced Cardiac Death/All MI [30 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  95. Number of Participants Experienced Cardiac Death/All MI [90 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  96. Number of Participants Experienced Cardiac Death/All MI [180 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  97. Number of Participants Experienced Cardiac Death/All MI [270 days]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  98. Number of Participants Experienced Cardiac Death/All MI [1 year]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  99. Number of Participants Experienced Cardiac Death/All MI [2 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  100. Number of Participants Experienced Cardiac Death/All MI [3 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  101. Number of Participants Experienced Cardiac Death/All MI [4 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  102. Number of Participants Experienced Cardiac Death/All MI [5 years]

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  103. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [In-hospital (≤ 7 days post index procedure)]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  104. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [30 days]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  105. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [90 days]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  106. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [180 days]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  107. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [270 days]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  108. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [1 year]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  109. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [2 years]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  110. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [3 years]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  111. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [4 years]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  112. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [5 years]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  113. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [In-hospital (≤ 7 days post index procedure)]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  114. Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) [30 days]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  115. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [90 days]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  116. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [180 days]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  117. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [270 days]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  118. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [1 year]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  119. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [2 years]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  120. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [3 years]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  121. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [4 years]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  122. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [5 years]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  123. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) [In-hospital (≤ 7 days post index procedure)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  124. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [30 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  125. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [90 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  126. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [180 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  127. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [270 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  128. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [1 year]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  129. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [2 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  130. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [3 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  131. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [4 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  132. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [5 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  133. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [In-hospital (≤ 7 days post index procedure)]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  134. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [30 days]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  135. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [90 days]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  136. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [180 days]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  137. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [270 days]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  138. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [1 year]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  139. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [2 years]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  140. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [3 years]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  141. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [4 years]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  142. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [5 years]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  143. Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) [0 - 24 hours post stent implantation]

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  144. Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) [>24 hours - 30 days post stent implantation]

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  145. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [30 days - 1 year post stent implantation]

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  146. Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) [0 to 730 Days]

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained

  147. Number of Participants With Rehospitalization [30 days]

    Coronary artery disease (CAD) related Cardiovascular, non-CAD related Non-cardiovascular related

  148. Number of Participants With Rehospitalization [90 days]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  149. Number of Participants With Rehospitalization [180 days]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  150. Number of Participants With Rehospitalization [270 days]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  151. Number of Participants With Rehospitalization [1 year]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  152. Number of Participants With Rehospitalization [2 years]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  153. Number of Participants With Rehospitalization [3 years]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  154. Number of Participants With Rehospitalization [4 years]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  155. Number of Participants With Rehospitalization [5 years]

    CAD related Cardiovascular, non-CAD related Non-cardiovascular related

  156. Number of Participants With Repeat Coronary Arteriography [In-hospital (≤ 7 days post index procedure)]

  157. Number of Participants With Repeat Coronary Arteriography [30 days]

  158. Number of Participants With Repeat Coronary Arteriography [90 days]

  159. Number of Participants With Repeat Coronary Arteriography [180 days]

  160. Number of Participants With Repeat Coronary Arteriography [270 days]

  161. Number of Participants With Repeat Coronary Arteriography [1 year]

  162. Number of Participants With Repeat Coronary Arteriography [2 years]

  163. Number of Participants With Repeat Coronary Arteriography [3 years]

  164. Number of Participants With Repeat Coronary Arteriography [4 years]

  165. Number of Participants With Repeat Coronary Arteriography [5 years]

  166. Landmark Analysis on MACE and TVF and Their Components [3-4 years]

  167. Landmark Analysis on MACE and TVF and Their Components [3-5 years]

  168. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-4 years]

  169. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-5 years]

  170. Number of Participants With Target Lesion Failure (TLF) [1 year]

    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

Other Outcome Measures

  1. Patient Reported Outcomes [Baseline]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  2. Patient Reported Outcomes [1 month]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  3. Patient Reported Outcomes [6 months]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  4. Patient Reported Outcomes [1 year]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  5. Patient Reported Outcomes [3 years]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  6. Patient Reported Outcomes (PRO) [5 years]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

  7. Landmark Analysis on TLF and Components [3-4 years]

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  8. Landmark Analysis on TLF and Components [3-5 years]

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
General Inclusion Criteria:
  1. Subject must be at least 18 years of age.

  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

  3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:

  4. Unstable angina or NSTEMI within 2 weeks of the index procedure.

  5. STEMI > 72 hours ≤ 2 weeks prior to the index procedure.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

  1. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

(Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)

  1. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

  2. 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.

  3. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.

  4. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

  1. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).

  2. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.

  3. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:
  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.

  2. 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.

  3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.

  4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.

  5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:

  6. Subject requires coumadin or any other agent for chronic oral anticoagulation.

  7. Subject is likely to become hemodynamically unstable due to their arrhythmia.

  8. Subject has poor survival prognosis due to their arrhythmia.

  9. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.

  10. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.

  11. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.

  12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

  13. At the time of screening, the subject has a malignancy that is not in remission.

  14. 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.

  15. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.

  16. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).

  17. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

  18. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.

  19. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.

  20. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.

  21. 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.).

  22. 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.

  23. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.

  24. 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.

  25. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

  26. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):

  2. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.

  3. TIMI flow grade <3 (per visual estimation).

  4. Any angiographic complication (e.g. distal embolization, side branch closure).

  5. Any dissection NHLBI grade D-F.

  6. Any chest pain lasting > 5 minutes.

  7. Any ST-segment depression or elevation lasting > 5 minutes.

  8. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).

  9. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).

  10. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).

  11. Lesion involving a bifurcation with a:

  12. side branch ≥ 2 mm in diameter, or

  13. side branch with either an ostial or non-ostial lesion with diameter stenosis

50%, or

  1. side branch requiring dilatation

  2. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or

XIENCE stent:
  1. Extreme angulation (≥ 90°) proximal to or within the target lesion.

  2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.

  3. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.

  4. Lesion or vessel involves a myocardial bridge.

  5. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.

  6. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233
2 Chandler Regional Medical Center Chandler Arizona United States 85224
3 Mercy Gilbert Medical Center Gilbert Arizona United States 85297
4 Scottsdale Healthcare Scottsdale Arizona United States 85258
5 Arkansas Heart Hospital Little Rock Arkansas United States 72211
6 John Muir Health Concord Concord California United States 94520
7 Washington Hospital Fremont California United States 94538
8 Scripps Memorial Hospital La Jolla La Jolla California United States 92037
9 Cedars-Sinai Medical Center Los Angeles California United States 90048
10 Univ Of California Davis Med Ctr Sacramento California United States 95817
11 Sharp Memorial Hospital San Diego California United States 92123
12 Stanford Hospital and Clinics Stanford California United States 94305
13 Little Company Of Mary Hospital Torrance California United States 90503
14 Medical Center of the Rockies Loveland Colorado United States 80538
15 Yale-New Haven Hospital New Haven Connecticut United States 06510
16 Morton Plant Hospital Clearwater Florida United States 33756
17 Holy Cross Hospital Fort Lauderdale Florida United States 33308
18 Baptist Medical Center Jacksonville Jacksonville Florida United States 32207
19 UF Health Jacksonville Jacksonville Florida United States 32209
20 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
21 Tampa General Hospital Tampa Florida United States 33606
22 Emory University Hospital Midtown Atlanta Georgia United States 30308
23 Emory University Hospital Atlanta Georgia United States 30322
24 Northwestern Memorial Hospital Chicago Illinois United States 60611
25 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
26 St. John's Hospital Springfield Illinois United States 62769
27 Elkhart General Hospital Elkhart Indiana United States 46514
28 Franciscan St Francis Health Indianapolis Indiana United States 46237
29 Baptist Health Lexington Lexington Kentucky United States 40503
30 University Of Kentucky Hospital Lexington Kentucky United States 40506
31 Jewish Hospital Louisville Kentucky United States 40202
32 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
33 Eastern Maine Medical Center Bangor Maine United States 04401
34 MedStar Union Memorial Hospital Baltimore Maryland United States 21218
35 Boston Medical Center Boston Massachusetts United States 02118
36 St. Joseph Mercy Hospital Ann Arbor Michigan United States 48197
37 Harper University Hospital Detroit Michigan United States 48201
38 St John Hospital & Medical Center Detroit Michigan United States 48236
39 Northern Michigan Hospital Petoskey Michigan United States 49770
40 William Beaumont Hospital Royal Oak Michigan United States 48073
41 North Mississippi Medical Center Tupelo Mississippi United States 38801
42 Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP Columbia Missouri United States 65201
43 Barnes Jewish Hospital Saint Louis Missouri United States 63110
44 Mercy Hospital Springfield Springfield Missouri United States 65804
45 St. Patrick Hospital Missoula Montana United States 59802
46 Nebraska Heart Institute Heart Hosp. Lincoln Nebraska United States 68526
47 CHI Health Bergan Mercy Omaha Nebraska United States 68124
48 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
49 Cooper University Hospital Camden New Jersey United States 08103
50 Our Lady of Lourdes Medical Center Camden New Jersey United States 08103
51 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
52 Montefiore Medical Center Bronx New York United States 10467
53 NewYork-Presbyterian/Queens Flushing New York United States 11355
54 NYP Weill Cornell Medical Center New York New York United States 10021
55 Mount Sinai Medical Center New York New York United States 10029
56 Columbia University Medical Center New York New York United States 10032
57 Rochester General Hospital Rochester New York United States 14621
58 Stony Brook University Medical Center Stony Brook New York United States 11794
59 St. Joseph's Hospital Health Center Syracuse New York United States 13203
60 Carolinas Medical Center-Northeast Charlotte North Carolina United States 28203
61 Carolinas Medical Center Charlotte North Carolina United States 28203
62 Novant Health Heart & Vascular Institute/Presbyterian Hospital Charlotte North Carolina United States 28204
63 Carolinas Medical Center-Pineville Charlotte North Carolina United States 28210
64 Rex Hospital, Inc. Raleigh North Carolina United States 27607
65 WakeMed Raleigh North Carolina United States 27610
66 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27103
67 Aultman Hospital Canton Ohio United States 44710
68 The Christ Hospital Cincinnati Ohio United States 45219
69 Cleveland Clinic Cleveland Ohio United States 44195
70 Ohio State University Medical Center Columbus Ohio United States 43210
71 Mercy St. Vincent Medical Center Toledo Ohio United States 43608
72 Genesis Hospital Zanesville Ohio United States 43701
73 Integris Baptist Medical Center, Inc. Oklahoma City Oklahoma United States 73112
74 Providence St. Vincent Medical Center Portland Oregon United States 97225
75 Holy Spirit Hospital Camp Hill Pennsylvania United States 17011
76 Geisinger Medical Center Danville Pennsylvania United States 17822
77 Doylestown Hospital Doylestown Pennsylvania United States 18901
78 Pinnacle Health Hospitals Harrisburg Pennsylvania United States 17105-8700
79 Forbes Hospital Monroeville Pennsylvania United States 15146
80 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
81 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
82 Upmc Presbyterian Pittsburgh Pennsylvania United States 15213
83 St. Joseph Medical Center Reading Pennsylvania United States 19605
84 Rhode Island Hospital Providence Rhode Island United States 02903
85 The Miriam Hospital Providence Rhode Island United States 02906
86 Anmed Health Medical Center Anderson South Carolina United States 29621
87 Providence Hospital Columbia South Carolina United States 29204
88 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
89 Vanderbilt University Medical Center Nashville Tennessee United States 37232
90 Northwest Texas Healthcare System Amarillo Texas United States 79106
91 Seton Medical Center Austin Texas United States 78705
92 Baylor Heart and Vascular Hospital Dallas Texas United States 75226
93 Houston Methodist Hospital Houston Texas United States 77030
94 East Texas Medical Center Tyler Texas United States 75701
95 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24014
96 Winchester Medical Center Winchester Virginia United States 22601
97 Providence Reg Med Ctr Everett Everett Washington United States 98201
98 Medstar Health Research Institute/ Medstar Washington Hospital Center Northwest Washington United States 20010
99 Liverpool Hospital Liverpool New South Wales Australia 2170
100 The Prince Charles Hospital Brisbane Queensland Australia 4032
101 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
102 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
103 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
104 Royal Perth Hospital Perth Western Australia Australia 6001
105 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
106 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
107 Hopital du Sacre-Coeur de Montreal Montreal Quebec Canada H4J 1C5
108 CHUM-Hotel Dieu Montréal Quebec Canada
109 Universitatsklinikum Freiburg Freiburg Baden-Württemberg Germany 79106
110 Universitätsklinikum Ulm Ulm Baden-Württemberg Germany 89081
111 Kliniken Oberallgau gGmbH Immenstadt Bavaria Germany 87509
112 Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH Kempten-Allgau Bavaria Germany 87439
113 Immanuel Klinikum Bernau Herzzentrum Brandenburg Bernau Berlin Germany 16321
114 University Giessen Giessen Hesse Germany 35392
115 Klinikum Oldenburg Oldenburg Lower Saxony Germany 26133
116 Universitatsklinikum Bonn Bonn North Rhine-Westphalia Germany 53105
117 Elisabeth-Krankenhaus Essen North Rhine-Westphalia Germany 45138
118 Johannes Gutenberg-Universitaet Mainz Rhineland-Palatinate Germany 55131
119 Segeberger Kliniken GmbH - Herzzentrum Bad Segeberg Schleswig-Holstein Germany 23795
120 National Heart Centre, Singapore, Pte, Ltd. Singapore Singapore 169609

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Chair: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
  • Principal Investigator: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
  • Principal Investigator: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH
  • Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02173379
Other Study ID Numbers:
  • 10-392 C
First Posted:
Jun 25, 2014
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022

Study Results

Participant Flow

Recruitment Details A total of 2604 subjects were randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 1-year follow-up visit occurred on March 31, 2018. The database was then cleaned and locked, and data extraction for the 2-year analysis occurred on June 04, 2019.
Pre-assignment Detail The last 2-year follow-up visit occurred on 16 April, 2019.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Period Title: Overall Study
STARTED 1296 1308
COMPLETED 1205 1231
NOT COMPLETED 91 77

Baseline Characteristics

Arm/Group Title Absorb BVS XIENCE Total
Arm/Group Description Subjects receiving public) Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) Total of all reporting groups
Overall Participants 1296 1308 2604
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
63.1
(10.1)
62.2
(10.3)
62.65
(10.2)
Sex: Female, Male (Count of Participants)
Female
369
28.5%
361
27.6%
730
28%
Male
927
71.5%
947
72.4%
1874
72%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
40
3.1%
29
2.2%
69
2.6%
Not Hispanic or Latino
0
0%
0
0%
0
0%
Unknown or Not Reported
1256
96.9%
1279
97.8%
2535
97.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
4
0.3%
8
0.6%
12
0.5%
Asian
30
2.3%
36
2.8%
66
2.5%
Native Hawaiian or Other Pacific Islander
11
0.8%
4
0.3%
15
0.6%
Black or African American
71
5.5%
61
4.7%
132
5.1%
White
1135
87.6%
1160
88.7%
2295
88.1%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
45
3.5%
39
3%
84
3.2%
Region of Enrollment (participants) [Number]
Canada
28
2.2%
26
2%
54
2.1%
United States
1021
78.8%
1041
79.6%
2062
79.2%
Australia
80
6.2%
68
5.2%
148
5.7%
Germany
164
12.7%
171
13.1%
335
12.9%
Singapore
3
0.2%
2
0.2%
5
0.2%
Prior Coronary Intervention (Count of Participants)
Count of Participants [Participants]
390
30.1%
435
33.3%
825
31.7%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Description Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
64
4.9%
48
3.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are: H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE < ∆TLF.
Type of Statistical Test Non-Inferiority
Comments One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.
Statistical Test of Hypothesis p-Value 0.0244
Comments
Method Farrington-Manning
Comments
2. Secondary Outcome
Title TLF at 1-year, Non-inferiority Against the Control
Description One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
98
7.6%
82
6.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments
Type of Statistical Test Non-Inferiority
Comments One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Statistical Test of Hypothesis p-Value 0.0006
Comments
Method Farrington-Manning
Comments
3. Secondary Outcome
Title Angina at 1-year, Non-inferiority Against the Control
Description Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1249 1261
Count of Participants [Participants]
253
19.5%
259
19.8%
4. Secondary Outcome
Title Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
Description Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Time Frame In-hospital (≤ 7days)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1303
Measure Target lesions 1424 1450
Number [Percentage of target lesions]
94.6
99.0
5. Secondary Outcome
Title Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
Description Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Time Frame In-hospital (≤ 7days)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1303
Count of Participants [Participants]
1203
92.8%
1250
95.6%
6. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
1
0.1%
0
0%
7. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
1
0.1%
1
0.1%
8. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
5
0.4%
5
0.4%
9. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
7
0.5%
8
0.6%
10. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
10
0.8%
11
0.8%
11. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
16
1.2%
14
1.1%
12. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
22
1.7%
22
1.7%
13. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
14. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
15. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
16. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
50
3.9%
43
3.3%
17. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
58
4.5%
47
3.6%
18. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
66
5.1%
50
3.8%
19. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
70
5.4%
56
4.3%
20. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
75
5.8%
62
4.7%
21. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
80
6.2%
65
5%
22. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
104
8%
86
6.6%
23. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
24. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
25. Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
26. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
50
3.9%
43
3.3%
27. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
57
4.4%
47
3.6%
28. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
63
4.9%
48
3.7%
29. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
67
5.2%
53
4.1%
30. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
71
5.5%
56
4.3%
31. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
75
5.8%
58
4.4%
32. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 2 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
94
7.3%
72
5.5%
33. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
34. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
35. Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
36. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
8
0.6%
1
0.1%
37. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
14
1.1%
3
0.2%
38. Secondary Outcome
Title Number of Participants withTarget Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
16
1.2%
4
0.3%
39. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
23
1.8%
11
0.8%
40. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
33
2.5%
15
1.1%
41. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
38
2.9%
24
1.8%
42. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
69
5.3%
36
2.8%
43. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
44. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
45. Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
46. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
8
0.6%
1
0.1%
47. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
13
1%
3
0.2%
48. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
15
1.2%
4
0.3%
49. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
22
1.7%
11
0.8%
50. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
32
2.5%
15
1.1%
51. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
37
2.9%
24
1.8%
52. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
66
5.1%
36
2.8%
53. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
54. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
55. Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
56. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
3
0.2%
0
0%
57. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
5
0.4%
1
0.1%
58. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
10
0.8%
6
0.5%
59. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
14
1.1%
14
1.1%
60. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
19
1.5%
16
1.2%
61. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
22
1.7%
18
1.4%
62. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
42
3.2%
36
2.8%
63. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
64. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
65. Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
66. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
3
0.2%
0
0%
67. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
5
0.4%
1
0.1%
68. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
10
0.8%
6
0.5%
69. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
14
1.1%
14
1.1%
70. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
19
1.5%
16
1.2%
71. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
22
1.7%
18
1.4%
72. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
40
3.1%
35
2.7%
73. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
74. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
75. Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. TVR includes all TVR, excluding TLR
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
76. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
10
0.8%
4
0.3%
77. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
19
1.5%
8
0.6%
78. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
28
2.2%
15
1.1%
79. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
41
3.2%
30
2.3%
80. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
54
4.2%
39
3%
81. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
63
4.9%
50
3.8%
82. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
114
8.8%
86
6.6%
83. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
84. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
85. Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
86. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
51
3.9%
43
3.3%
87. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
59
4.6%
48
3.7%
88. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
69
5.3%
55
4.2%
89. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
74
5.7%
64
4.9%
90. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
80
6.2%
72
5.5%
91. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
89
6.9%
78
6%
92. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
116
9%
106
8.1%
93. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
94. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
95. Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
96. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
51
3.9%
43
3.3%
97. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
59
4.6%
47
3.6%
98. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
67
5.2%
53
4.1%
99. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
71
5.5%
61
4.7%
100. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
77
5.9%
68
5.2%
101. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
83
6.4%
72
5.5%
102. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
107
8.3%
96
7.3%
103. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
104. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
105. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
106. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
57
4.4%
44
3.4%
107. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
64
4.9%
48
3.7%
108. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
71
5.5%
53
4.1%
109. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
77
5.9%
64
4.9%
110. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
90
6.9%
71
5.4%
111. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
98
7.6%
82
6.3%
112. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
137
10.6%
105
8%
113. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
114. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
115. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
116. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
57
4.4%
44
3.4%
117. Secondary Outcome
Title Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
65
5%
48
3.7%
118. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
74
5.7%
55
4.2%
119. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
80
6.2%
67
5.1%
120. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
93
7.2%
77
5.9%
121. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
102
7.9%
88
6.7%
122. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
145
11.2%
119
9.1%
123. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
124. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
125. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
126. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
57
4.4%
44
3.4%
127. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
66
5.1%
48
3.7%
128. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
77
5.9%
59
4.5%
129. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
86
6.6%
75
5.7%
130. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
101
7.8%
86
6.6%
131. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
111
8.6%
99
7.6%
132. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
160
12.3%
136
10.4%
133. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
134. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
135. Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
136. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1304
Count of Participants [Participants]
57
4.4%
46
3.5%
137. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1303
Count of Participants [Participants]
67
5.2%
53
4.1%
138. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1286 1300
Count of Participants [Participants]
81
6.3%
65
5%
139. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1291
Count of Participants [Participants]
94
7.3%
82
6.3%
140. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1264 1279
Count of Participants [Participants]
110
8.5%
97
7.4%
141. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1272
Count of Participants [Participants]
124
9.6%
112
8.6%
142. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1232 1255
Count of Participants [Participants]
182
14%
158
12.1%
143. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
144. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
145. Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
146. Secondary Outcome
Title Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame 0 - 24 hours post stent implantation

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1291 1305
Definite
3
0.2%
0
0%
Definite/Probable
4
0.3%
0
0%
Probable
1
0.1%
0
0%
147. Secondary Outcome
Title Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)
Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame >24 hours - 30 days post stent implantation

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1287 1301
Definite
4
0.3%
2
0.2%
Definite/Probable
4
0.3%
2
0.2%
Probable
0
0%
0
0%
148. Secondary Outcome
Title Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)
Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame 30 days - 1 year post stent implantation

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1238 1258
Definite
1
0.1%
2
0.2%
Definite/Probable
1
0.1%
2
0.2%
Probable
0
0%
0
0%
149. Secondary Outcome
Title Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)
Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Time Frame 0 to 730 Days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1210 1231
Definite
11
0.8%
6
0.5%
Definite/Probable
12
0.9%
6
0.5%
Probable
1
0.1%
0
0%
150. Secondary Outcome
Title Number of Participants With Rehospitalization
Description Coronary artery disease (CAD) related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1302
Count of Participants [Participants]
65
5%
59
4.5%
151. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1285 1298
Count of Participants [Participants]
111
8.6%
122
9.3%
152. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1283 1290
Count of Participants [Participants]
177
13.7%
177
13.5%
153. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1266 1278
Count of Participants [Participants]
226
17.4%
236
18%
154. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1254 1271
Count of Participants [Participants]
276
21.3%
288
22%
155. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1238 1254
Count of Participants [Participants]
440
34%
445
34%
156. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
157. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
158. Secondary Outcome
Title Number of Participants With Rehospitalization
Description CAD related Cardiovascular, non-CAD related Non-cardiovascular related
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
159. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame In-hospital (≤ 7 days post index procedure)

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1290 1304
Count of Participants [Participants]
4
0.3%
7
0.5%
160. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1288 1301
Count of Participants [Participants]
18
1.4%
21
1.6%
161. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1282 1295
Count of Participants [Participants]
33
2.5%
40
3.1%
162. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 180 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1279 1283
Count of Participants [Participants]
57
4.4%
64
4.9%
163. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 270 days

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1260 1270
Count of Participants [Participants]
71
5.5%
86
6.6%
164. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1242 1260
Count of Participants [Participants]
84
6.5%
102
7.8%
165. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Measure Participants 1218 1236
Count of Participants [Participants]
140
10.8%
160
12.2%
166. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
167. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
168. Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Description
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
169. Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Description
Time Frame 3-4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
170. Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Description
Time Frame 3-5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
171. Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description
Time Frame 3-4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
172. Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description
Time Frame 3-5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
173. Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Description The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
174. Other Pre-specified Outcome
Title Patient Reported Outcomes
Description Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
175. Other Pre-specified Outcome
Title Patient Reported Outcomes
Description Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame 1 month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
176. Other Pre-specified Outcome
Title Patient Reported Outcomes
Description Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
177. Other Pre-specified Outcome
Title Patient Reported Outcomes
Description Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
178. Other Pre-specified Outcome
Title Patient Reported Outcomes
Description Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
179. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO)
Description Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
180. Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
181. Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame 2 years
Adverse Event Reporting Description
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
All Cause Mortality
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 22/1296 (1.7%) 22/1308 (1.7%)
Serious Adverse Events
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 637/1296 (49.2%) 588/1308 (45%)
Blood and lymphatic system disorders
ANAEMIA 4/1296 (0.3%) 5/1308 (0.4%)
HAEMORRHAGIC ANAEMIA 0/1296 (0%) 3/1308 (0.2%)
IRON DEFICIENCY ANAEMIA 2/1296 (0.2%) 4/1308 (0.3%)
NORMOCHROMIC NORMOCYTIC ANAEMIA 1/1296 (0.1%) 0/1308 (0%)
PANCYTOPENIA 0/1296 (0%) 1/1308 (0.1%)
THROMBOCYTOPENIA 1/1296 (0.1%) 0/1308 (0%)
Cardiac disorders
ACUTE CORONARY SYNDROME 8/1296 (0.6%) 3/1308 (0.2%)
ACUTE LEFT VENTRICULAR FAILURE 0/1296 (0%) 1/1308 (0.1%)
ACUTE MYOCARDIAL INFARCTION 16/1296 (1.2%) 24/1308 (1.8%)
ANGINA PECTORIS 94/1296 (7.3%) 74/1308 (5.7%)
ANGINA UNSTABLE 29/1296 (2.2%) 39/1308 (3%)
AORTIC VALVE INCOMPETENCE 1/1296 (0.1%) 0/1308 (0%)
AORTIC VALVE STENOSIS 0/1296 (0%) 1/1308 (0.1%)
ARTERIOSCLEROSIS CORONARY ARTERY 3/1296 (0.2%) 1/1308 (0.1%)
ARTERIOSPASM CORONARY 0/1296 (0%) 1/1308 (0.1%)
ATRIAL FIBRILLATION 19/1296 (1.5%) 9/1308 (0.7%)
ATRIAL FLUTTER 1/1296 (0.1%) 1/1308 (0.1%)
ATRIOVENTRICULAR BLOCK 0/1296 (0%) 1/1308 (0.1%)
ATRIOVENTRICULAR BLOCK COMPLETE 2/1296 (0.2%) 2/1308 (0.2%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE 1/1296 (0.1%) 0/1308 (0%)
BRADYCARDIA 0/1296 (0%) 3/1308 (0.2%)
BUNDLE BRANCH BLOCK LEFT 0/1296 (0%) 1/1308 (0.1%)
CARDIAC ARREST 4/1296 (0.3%) 2/1308 (0.2%)
CARDIAC FAILURE 6/1296 (0.5%) 1/1308 (0.1%)
CARDIAC FAILURE ACUTE 2/1296 (0.2%) 1/1308 (0.1%)
CARDIAC FAILURE CHRONIC 4/1296 (0.3%) 2/1308 (0.2%)
CARDIAC FAILURE CONGESTIVE 11/1296 (0.8%) 10/1308 (0.8%)
CARDIAC PERFORATION 1/1296 (0.1%) 0/1308 (0%)
CARDIO-RESPIRATORY ARREST 0/1296 (0%) 1/1308 (0.1%)
CARDIOGENIC SHOCK 5/1296 (0.4%) 0/1308 (0%)
CARDIOMYOPATHY 0/1296 (0%) 1/1308 (0.1%)
CHRONOTROPIC INCOMPETENCE 0/1296 (0%) 1/1308 (0.1%)
CONGESTIVE CARDIOMYOPATHY 0/1296 (0%) 1/1308 (0.1%)
CORONARY ARTERY DISEASE 26/1296 (2%) 16/1308 (1.2%)
CORONARY ARTERY DISSECTION 40/1296 (3.1%) 17/1308 (1.3%)
CORONARY ARTERY EMBOLISM 1/1296 (0.1%) 0/1308 (0%)
CORONARY ARTERY OCCLUSION 0/1296 (0%) 3/1308 (0.2%)
CORONARY ARTERY PERFORATION 1/1296 (0.1%) 1/1308 (0.1%)
CORONARY ARTERY STENOSIS 7/1296 (0.5%) 3/1308 (0.2%)
HYPERTENSIVE HEART DISEASE 0/1296 (0%) 1/1308 (0.1%)
HYPERTROPHIC CARDIOMYOPATHY 1/1296 (0.1%) 0/1308 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS 1/1296 (0.1%) 0/1308 (0%)
INTRACARDIAC THROMBUS 1/1296 (0.1%) 0/1308 (0%)
ISCHAEMIC CARDIOMYOPATHY 1/1296 (0.1%) 2/1308 (0.2%)
MITRAL VALVE INCOMPETENCE 2/1296 (0.2%) 0/1308 (0%)
MYOCARDIAL INFARCTION 34/1296 (2.6%) 23/1308 (1.8%)
MYOCARDIAL ISCHAEMIA 3/1296 (0.2%) 2/1308 (0.2%)
MYOPERICARDITIS 0/1296 (0%) 1/1308 (0.1%)
PALPITATIONS 1/1296 (0.1%) 1/1308 (0.1%)
PERICARDIAL EFFUSION 1/1296 (0.1%) 0/1308 (0%)
PERICARDITIS 1/1296 (0.1%) 2/1308 (0.2%)
PRINZMETAL ANGINA 1/1296 (0.1%) 1/1308 (0.1%)
SICK SINUS SYNDROME 1/1296 (0.1%) 2/1308 (0.2%)
SUPRAVENTRICULAR TACHYCARDIA 2/1296 (0.2%) 3/1308 (0.2%)
TACHYCARDIA 0/1296 (0%) 1/1308 (0.1%)
VENTRICULAR FIBRILLATION 4/1296 (0.3%) 0/1308 (0%)
VENTRICULAR TACHYCARDIA 2/1296 (0.2%) 4/1308 (0.3%)
Congenital, familial and genetic disorders
CONGENITAL ARTERIAL MALFORMATION 1/1296 (0.1%) 0/1308 (0%)
CORNEAL DYSTROPHY 1/1296 (0.1%) 0/1308 (0%)
PHIMOSIS 0/1296 (0%) 0/1308 (0%)
Ear and labyrinth disorders
VERTIGO 0/1296 (0%) 1/1308 (0.1%)
VERTIGO POSITIONAL 0/1296 (0%) 2/1308 (0.2%)
Endocrine disorders
CARCINOID SYNDROME 0/1296 (0%) 1/1308 (0.1%)
GOITRE 0/1296 (0%) 1/1308 (0.1%)
HYPERPARATHYROIDISM 0/1296 (0%) 1/1308 (0.1%)
THYROID MASS 0/1296 (0%) 1/1308 (0.1%)
Eye disorders
CATARACT 2/1296 (0.2%) 2/1308 (0.2%)
MACULAR FIBROSIS 0/1296 (0%) 1/1308 (0.1%)
RETINAL ARTERY EMBOLISM 0/1296 (0%) 1/1308 (0.1%)
RETINAL DETACHMENT 0/1296 (0%) 1/1308 (0.1%)
TOLOSA-HUNT SYNDROME 0/1296 (0%) 1/1308 (0.1%)
Gastrointestinal disorders
ABDOMINAL PAIN 5/1296 (0.4%) 4/1308 (0.3%)
ABDOMINAL PAIN LOWER 0/1296 (0%) 1/1308 (0.1%)
ASCITES 1/1296 (0.1%) 1/1308 (0.1%)
BARRETT'S OESOPHAGUS 0/1296 (0%) 1/1308 (0.1%)
COLITIS 4/1296 (0.3%) 0/1308 (0%)
COLITIS ISCHAEMIC 0/1296 (0%) 1/1308 (0.1%)
COLITIS ULCERATIVE 1/1296 (0.1%) 0/1308 (0%)
COLONIC POLYP 1/1296 (0.1%) 2/1308 (0.2%)
CONSTIPATION 1/1296 (0.1%) 1/1308 (0.1%)
CROHN'S DISEASE 1/1296 (0.1%) 0/1308 (0%)
DENTAL CARIES 1/1296 (0.1%) 0/1308 (0%)
DIVERTICULITIS INTESTINAL HAEMORRHAGIC 0/1296 (0%) 3/1308 (0.2%)
DIVERTICULUM 1/1296 (0.1%) 0/1308 (0%)
DIVERTICULUM INTESTINAL 0/1296 (0%) 2/1308 (0.2%)
DIVERTICULUM INTESTINAL HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
DUODENAL ULCER 0/1296 (0%) 1/1308 (0.1%)
DUODENAL ULCER PERFORATION 1/1296 (0.1%) 0/1308 (0%)
DYSPEPSIA 1/1296 (0.1%) 0/1308 (0%)
FAECALOMA 0/1296 (0%) 1/1308 (0.1%)
GASTRIC ULCER 1/1296 (0.1%) 1/1308 (0.1%)
GASTRIC ULCER HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
GASTRITIS 2/1296 (0.2%) 4/1308 (0.3%)
GASTRITIS EROSIVE 0/1296 (0%) 1/1308 (0.1%)
GASTRITIS HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
GASTROINTESTINAL HAEMORRHAGE 6/1296 (0.5%) 11/1308 (0.8%)
GASTROINTESTINAL ULCER HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
GASTROOESOPHAGEAL REFLUX DISEASE 3/1296 (0.2%) 3/1308 (0.2%)
GINGIVAL BLEEDING 1/1296 (0.1%) 0/1308 (0%)
HAEMATEMESIS 0/1296 (0%) 1/1308 (0.1%)
HAEMORRHOIDAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
HAEMORRHOIDS 1/1296 (0.1%) 0/1308 (0%)
HIATUS HERNIA 2/1296 (0.2%) 0/1308 (0%)
ILEUS 1/1296 (0.1%) 0/1308 (0%)
IMPAIRED GASTRIC EMPTYING 1/1296 (0.1%) 1/1308 (0.1%)
INGUINAL HERNIA 4/1296 (0.3%) 1/1308 (0.1%)
INTESTINAL MASS 1/1296 (0.1%) 0/1308 (0%)
LOWER GASTROINTESTINAL HAEMORRHAGE 1/1296 (0.1%) 1/1308 (0.1%)
MALLORY-WEISS SYNDROME 0/1296 (0%) 1/1308 (0.1%)
NAUSEA 1/1296 (0.1%) 1/1308 (0.1%)
OESOPHAGEAL STENOSIS 1/1296 (0.1%) 0/1308 (0%)
PANCREATITIS 0/1296 (0%) 3/1308 (0.2%)
PANCREATITIS ACUTE 0/1296 (0%) 3/1308 (0.2%)
PANCREATITIS CHRONIC 0/1296 (0%) 1/1308 (0.1%)
RECTAL HAEMORRHAGE 1/1296 (0.1%) 2/1308 (0.2%)
RETROPERITONEAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
SMALL INTESTINAL OBSTRUCTION 3/1296 (0.2%) 4/1308 (0.3%)
SPIGELIAN HERNIA 0/1296 (0%) 1/1308 (0.1%)
STOMATITIS 1/1296 (0.1%) 0/1308 (0%)
UMBILICAL HERNIA 1/1296 (0.1%) 2/1308 (0.2%)
UPPER GASTROINTESTINAL HAEMORRHAGE 3/1296 (0.2%) 0/1308 (0%)
VOLVULUS 1/1296 (0.1%) 0/1308 (0%)
General disorders
ADVERSE DRUG REACTION 3/1296 (0.2%) 8/1308 (0.6%)
ASTHENIA 0/1296 (0%) 1/1308 (0.1%)
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE 1/1296 (0.1%) 0/1308 (0%)
CATHETER SITE HAEMATOMA 4/1296 (0.3%) 1/1308 (0.1%)
CATHETER SITE NECROSIS 0/1296 (0%) 1/1308 (0.1%)
CHEST DISCOMFORT 6/1296 (0.5%) 7/1308 (0.5%)
CHEST PAIN 23/1296 (1.8%) 22/1308 (1.7%)
COMPLICATION OF DEVICE REMOVAL 1/1296 (0.1%) 0/1308 (0%)
DEATH 1/1296 (0.1%) 4/1308 (0.3%)
DEVICE FAILURE 1/1296 (0.1%) 0/1308 (0%)
DEVICE ISSUE 1/1296 (0.1%) 1/1308 (0.1%)
DEVICE LEAD DAMAGE 0/1296 (0%) 1/1308 (0.1%)
DEVICE MALFUNCTION 1/1296 (0.1%) 0/1308 (0%)
EARLY SATIETY 0/1296 (0%) 1/1308 (0.1%)
FACIAL PAIN 0/1296 (0%) 1/1308 (0.1%)
FATIGUE 2/1296 (0.2%) 0/1308 (0%)
IMPAIRED HEALING 0/1296 (0%) 2/1308 (0.2%)
MEDICAL DEVICE SITE REACTION 1/1296 (0.1%) 0/1308 (0%)
NON-CARDIAC CHEST PAIN 48/1296 (3.7%) 58/1308 (4.4%)
PAIN 0/1296 (0%) 1/1308 (0.1%)
PYREXIA 2/1296 (0.2%) 0/1308 (0%)
THROMBOSIS IN DEVICE 8/1296 (0.6%) 6/1308 (0.5%)
ULCER 0/1296 (0%) 1/1308 (0.1%)
Hepatobiliary disorders
ACUTE HEPATIC FAILURE 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT OBSTRUCTION 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT STONE 0/1296 (0%) 3/1308 (0.2%)
CHOLANGITIS 1/1296 (0.1%) 0/1308 (0%)
CHOLANGITIS ACUTE 1/1296 (0.1%) 0/1308 (0%)
CHOLECYSTITIS 3/1296 (0.2%) 2/1308 (0.2%)
CHOLECYSTITIS ACUTE 1/1296 (0.1%) 1/1308 (0.1%)
CHOLECYSTITIS CHRONIC 0/1296 (0%) 1/1308 (0.1%)
CHOLELITHIASIS 4/1296 (0.3%) 2/1308 (0.2%)
GALLBLADDER DISORDER 1/1296 (0.1%) 1/1308 (0.1%)
HEPATIC CIRRHOSIS 0/1296 (0%) 1/1308 (0.1%)
HEPATIC STEATOSIS 1/1296 (0.1%) 0/1308 (0%)
ISCHAEMIC HEPATITIS 1/1296 (0.1%) 0/1308 (0%)
Immune system disorders
ANAPHYLACTIC REACTION 1/1296 (0.1%) 0/1308 (0%)
DRUG HYPERSENSITIVITY 1/1296 (0.1%) 0/1308 (0%)
Infections and infestations
ABSCESS LIMB 1/1296 (0.1%) 0/1308 (0%)
ABSCESS NECK 1/1296 (0.1%) 0/1308 (0%)
ABSCESS ORAL 0/1296 (0%) 1/1308 (0.1%)
APPENDICITIS 3/1296 (0.2%) 4/1308 (0.3%)
ARTERIOVENOUS GRAFT SITE INFECTION 0/1296 (0%) 1/1308 (0.1%)
ARTHRITIS INFECTIVE 1/1296 (0.1%) 0/1308 (0%)
BACTERIAL SEPSIS 0/1296 (0%) 1/1308 (0.1%)
BRONCHITIS 3/1296 (0.2%) 2/1308 (0.2%)
BRONCHITIS VIRAL 0/1296 (0%) 3/1308 (0.2%)
BRONCHOPNEUMONIA 0/1296 (0%) 1/1308 (0.1%)
CELLULITIS 4/1296 (0.3%) 4/1308 (0.3%)
CHOLECYSTITIS INFECTIVE 0/1296 (0%) 1/1308 (0.1%)
CLOSTRIDIAL INFECTION 1/1296 (0.1%) 2/1308 (0.2%)
CLOSTRIDIUM COLITIS 0/1296 (0%) 1/1308 (0.1%)
DIABETIC FOOT INFECTION 1/1296 (0.1%) 0/1308 (0%)
DIVERTICULITIS 3/1296 (0.2%) 4/1308 (0.3%)
EAR INFECTION 0/1296 (0%) 1/1308 (0.1%)
EMPYEMA 0/1296 (0%) 1/1308 (0.1%)
ESCHERICHIA BACTERAEMIA 1/1296 (0.1%) 0/1308 (0%)
ESCHERICHIA INFECTION 1/1296 (0.1%) 0/1308 (0%)
ESCHERICHIA SEPSIS 0/1296 (0%) 1/1308 (0.1%)
ESCHERICHIA URINARY TRACT INFECTION 0/1296 (0%) 1/1308 (0.1%)
EXTRADURAL ABSCESS 0/1296 (0%) 1/1308 (0.1%)
GANGRENE 1/1296 (0.1%) 0/1308 (0%)
GASTROENTERITIS 1/1296 (0.1%) 6/1308 (0.5%)
INFECTIOUS PLEURAL EFFUSION 1/1296 (0.1%) 0/1308 (0%)
INFLUENZA 2/1296 (0.2%) 2/1308 (0.2%)
LABYRINTHITIS 0/1296 (0%) 1/1308 (0.1%)
LIVER ABSCESS 1/1296 (0.1%) 0/1308 (0%)
LOBAR PNEUMONIA 2/1296 (0.2%) 3/1308 (0.2%)
LUNG INFECTION PSEUDOMONAL 0/1296 (0%) 1/1308 (0.1%)
NECROTISING FASCIITIS 0/1296 (0%) 1/1308 (0.1%)
OSTEOMYELITIS 0/1296 (0%) 1/1308 (0.1%)
PNEUMONIA 13/1296 (1%) 14/1308 (1.1%)
POSTOPERATIVE WOUND INFECTION 1/1296 (0.1%) 0/1308 (0%)
PYELONEPHRITIS 1/1296 (0.1%) 2/1308 (0.2%)
PYELONEPHRITIS ACUTE 1/1296 (0.1%) 0/1308 (0%)
SEPSIS 8/1296 (0.6%) 5/1308 (0.4%)
SEPTIC SHOCK 1/1296 (0.1%) 1/1308 (0.1%)
STAPHYLOCOCCAL SEPSIS 0/1296 (0%) 1/1308 (0.1%)
TOOTH INFECTION 1/1296 (0.1%) 0/1308 (0%)
URINARY TRACT INFECTION 2/1296 (0.2%) 5/1308 (0.4%)
UROSEPSIS 0/1296 (0%) 1/1308 (0.1%)
VIRAL INFECTION 1/1296 (0.1%) 0/1308 (0%)
VIRAL LABYRINTHITIS 1/1296 (0.1%) 0/1308 (0%)
WOUND INFECTION 1/1296 (0.1%) 0/1308 (0%)
WOUND INFECTION BACTERIAL 1/1296 (0.1%) 0/1308 (0%)
Injury, poisoning and procedural complications
ACETABULUM FRACTURE 1/1296 (0.1%) 0/1308 (0%)
ANASTOMOTIC ULCER HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
ANKLE FRACTURE 1/1296 (0.1%) 3/1308 (0.2%)
ARTHROPOD STING 1/1296 (0.1%) 0/1308 (0%)
BACK INJURY 0/1296 (0%) 1/1308 (0.1%)
CARDIAC PROCEDURE COMPLICATION 2/1296 (0.2%) 2/1308 (0.2%)
CATHETER SITE HAEMATOMA 1/1296 (0.1%) 1/1308 (0.1%)
CERVICAL VERTEBRAL FRACTURE 1/1296 (0.1%) 0/1308 (0%)
COMMINUTED FRACTURE 0/1296 (0%) 1/1308 (0.1%)
CONFUSION POSTOPERATIVE 2/1296 (0.2%) 0/1308 (0%)
CORONARY ARTERY RESTENOSIS 31/1296 (2.4%) 19/1308 (1.5%)
FACIAL BONES FRACTURE 1/1296 (0.1%) 0/1308 (0%)
FALL 3/1296 (0.2%) 2/1308 (0.2%)
FEMUR FRACTURE 1/1296 (0.1%) 0/1308 (0%)
FOOT FRACTURE 0/1296 (0%) 1/1308 (0.1%)
FOREARM FRACTURE 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL STOMA COMPLICATION 1/1296 (0.1%) 0/1308 (0%)
HAND FRACTURE 0/1296 (0%) 1/1308 (0.1%)
HEAT EXHAUSTION 1/1296 (0.1%) 0/1308 (0%)
HIP FRACTURE 0/1296 (0%) 1/1308 (0.1%)
IN-STENT ARTERIAL RESTENOSIS 2/1296 (0.2%) 0/1308 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS 6/1296 (0.5%) 7/1308 (0.5%)
INJURY 1/1296 (0.1%) 1/1308 (0.1%)
JOINT DISLOCATION 0/1296 (0%) 2/1308 (0.2%)
LACERATION 2/1296 (0.2%) 0/1308 (0%)
LIGAMENT RUPTURE 1/1296 (0.1%) 0/1308 (0%)
LIMB INJURY 1/1296 (0.1%) 0/1308 (0%)
OVERDOSE 1/1296 (0.1%) 1/1308 (0.1%)
PATELLA FRACTURE 0/1296 (0%) 1/1308 (0.1%)
PELVIC FRACTURE 0/1296 (0%) 1/1308 (0.1%)
PELVIC ORGAN INJURY 0/1296 (0%) 1/1308 (0.1%)
PERIPROSTHETIC FRACTURE 1/1296 (0.1%) 0/1308 (0%)
PLAQUE SHIFT 0/1296 (0%) 1/1308 (0.1%)
POISONING 0/1296 (0%) 1/1308 (0.1%)
POISONING DELIBERATE 0/1296 (0%) 1/1308 (0.1%)
POST PROCEDURAL COMPLICATION 0/1296 (0%) 1/1308 (0.1%)
POST PROCEDURAL MYOCARDIAL INFARCTION 11/1296 (0.8%) 6/1308 (0.5%)
POST-TRAUMATIC PAIN 0/1296 (0%) 3/1308 (0.2%)
POSTOPERATIVE ILEUS 1/1296 (0.1%) 0/1308 (0%)
POSTOPERATIVE RESPIRATORY DISTRESS 1/1296 (0.1%) 0/1308 (0%)
PROCEDURAL HYPERTENSION 0/1296 (0%) 1/1308 (0.1%)
PROCEDURAL PAIN 1/1296 (0.1%) 2/1308 (0.2%)
PROCEDURAL VOMITING 1/1296 (0.1%) 0/1308 (0%)
RADIUS FRACTURE 0/1296 (0%) 1/1308 (0.1%)
RIB FRACTURE 1/1296 (0.1%) 1/1308 (0.1%)
ROAD TRAFFIC ACCIDENT 0/1296 (0%) 1/1308 (0.1%)
SPINAL COMPRESSION FRACTURE 0/1296 (0%) 1/1308 (0.1%)
STAB WOUND 0/1296 (0%) 1/1308 (0.1%)
SUBDURAL HAEMATOMA 0/1296 (0%) 3/1308 (0.2%)
TENDON RUPTURE 2/1296 (0.2%) 0/1308 (0%)
THORACIC VERTEBRAL FRACTURE 0/1296 (0%) 1/1308 (0.1%)
TRAUMATIC HAEMATOMA 0/1296 (0%) 1/1308 (0.1%)
TRAUMATIC INTRACRANIAL HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
TRAUMATIC LUNG INJURY 0/1296 (0%) 1/1308 (0.1%)
URINARY RETENTION POSTOPERATIVE 0/1296 (0%) 1/1308 (0.1%)
VASCULAR GRAFT COMPLICATION 0/1296 (0%) 1/1308 (0.1%)
VASCULAR GRAFT OCCLUSION 0/1296 (0%) 1/1308 (0.1%)
VASCULAR PSEUDOANEURYSM 3/1296 (0.2%) 5/1308 (0.4%)
WOUND DEHISCENCE 0/1296 (0%) 1/1308 (0.1%)
WRIST FRACTURE 0/1296 (0%) 2/1308 (0.2%)
Investigations
ARTERIOGRAM CORONARY 1/1296 (0.1%) 0/1308 (0%)
BLOOD CREATINE PHOSPHOKINASE INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED 1/1296 (0.1%) 1/1308 (0.1%)
BLOOD GLUCOSE DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD GLUCOSE INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD PRESSURE INCREASED 1/1296 (0.1%) 0/1308 (0%)
CARDIAC ENZYMES INCREASED 4/1296 (0.3%) 3/1308 (0.2%)
CARDIAC STRESS TEST ABNORMAL 0/1296 (0%) 1/1308 (0.1%)
EJECTION FRACTION DECREASED 1/1296 (0.1%) 0/1308 (0%)
ELECTROCARDIOGRAM ABNORMAL 2/1296 (0.2%) 0/1308 (0%)
GLYCOSYLATED HAEMOGLOBIN INCREASED 0/1296 (0%) 1/1308 (0.1%)
HAEMOGLOBIN DECREASED 0/1296 (0%) 1/1308 (0.1%)
TRANSAMINASES INCREASED 0/1296 (0%) 1/1308 (0.1%)
TROPONIN INCREASED 4/1296 (0.3%) 2/1308 (0.2%)
Metabolism and nutrition disorders
DEHYDRATION 2/1296 (0.2%) 1/1308 (0.1%)
DIABETES MELLITUS 0/1296 (0%) 1/1308 (0.1%)
DIABETIC KETOACIDOSIS 1/1296 (0.1%) 5/1308 (0.4%)
FAILURE TO THRIVE 1/1296 (0.1%) 0/1308 (0%)
HYPERCALCAEMIA 0/1296 (0%) 1/1308 (0.1%)
HYPERGLYCAEMIA 2/1296 (0.2%) 1/1308 (0.1%)
HYPERKALAEMIA 2/1296 (0.2%) 0/1308 (0%)
HYPOGLYCAEMIA 1/1296 (0.1%) 1/1308 (0.1%)
HYPONATRAEMIA 0/1296 (0%) 1/1308 (0.1%)
HYPOVOLAEMIA 1/1296 (0.1%) 0/1308 (0%)
KETOACIDOSIS 1/1296 (0.1%) 0/1308 (0%)
LACTIC ACIDOSIS 0/1296 (0%) 1/1308 (0.1%)
OBESITY 0/1296 (0%) 1/1308 (0.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 2/1296 (0.2%) 2/1308 (0.2%)
ARTHRITIS 3/1296 (0.2%) 2/1308 (0.2%)
ARTHROPATHY 1/1296 (0.1%) 0/1308 (0%)
BACK PAIN 5/1296 (0.4%) 5/1308 (0.4%)
BURSITIS 0/1296 (0%) 1/1308 (0.1%)
CERVICAL SPINAL STENOSIS 1/1296 (0.1%) 2/1308 (0.2%)
COSTOCHONDRITIS 0/1296 (0%) 1/1308 (0.1%)
FOOT DEFORMITY 2/1296 (0.2%) 0/1308 (0%)
INTERVERTEBRAL DISC DEGENERATION 0/1296 (0%) 1/1308 (0.1%)
INTERVERTEBRAL DISC PROTRUSION 2/1296 (0.2%) 1/1308 (0.1%)
JOINT SWELLING 1/1296 (0.1%) 0/1308 (0%)
LUMBAR SPINAL STENOSIS 3/1296 (0.2%) 3/1308 (0.2%)
MUSCLE SPASMS 1/1296 (0.1%) 1/1308 (0.1%)
MUSCULAR WEAKNESS 2/1296 (0.2%) 1/1308 (0.1%)
MUSCULOSKELETAL CHEST PAIN 1/1296 (0.1%) 3/1308 (0.2%)
MUSCULOSKELETAL PAIN 2/1296 (0.2%) 2/1308 (0.2%)
MYALGIA 0/1296 (0%) 1/1308 (0.1%)
NECK PAIN 2/1296 (0.2%) 0/1308 (0%)
OSTEOARTHRITIS 11/1296 (0.8%) 11/1308 (0.8%)
OSTEOCHONDROSIS 0/1296 (0%) 1/1308 (0.1%)
PAIN IN EXTREMITY 2/1296 (0.2%) 3/1308 (0.2%)
RHABDOMYOLYSIS 2/1296 (0.2%) 0/1308 (0%)
ROTATOR CUFF SYNDROME 1/1296 (0.1%) 3/1308 (0.2%)
SPINAL COLUMN STENOSIS 0/1296 (0%) 2/1308 (0.2%)
SPINAL DISORDER 1/1296 (0.1%) 1/1308 (0.1%)
SPINAL OSTEOARTHRITIS 1/1296 (0.1%) 1/1308 (0.1%)
TENDONITIS 0/1296 (0%) 1/1308 (0.1%)
VERTEBRAL FORAMINAL STENOSIS 0/1296 (0%) 1/1308 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE PROMYELOCYTIC LEUKAEMIA 1/1296 (0.1%) 0/1308 (0%)
ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
B-CELL LYMPHOMA 1/1296 (0.1%) 0/1308 (0%)
B-CELL LYMPHOMA STAGE I 0/1296 (0%) 1/1308 (0.1%)
B-CELL LYMPHOMA STAGE IV 0/1296 (0%) 1/1308 (0.1%)
BASAL CELL CARCINOMA 3/1296 (0.2%) 4/1308 (0.3%)
BENIGN SOFT TISSUE NEOPLASM 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT CANCER 1/1296 (0.1%) 0/1308 (0%)
BLADDER CANCER 1/1296 (0.1%) 0/1308 (0%)
BOWEN'S DISEASE 0/1296 (0%) 1/1308 (0.1%)
BREAST CANCER 1/1296 (0.1%) 1/1308 (0.1%)
BREAST CANCER IN SITU 1/1296 (0.1%) 0/1308 (0%)
BREAST CANCER STAGE II 1/1296 (0.1%) 0/1308 (0%)
COLON ADENOMA 1/1296 (0.1%) 0/1308 (0%)
COLON CANCER 3/1296 (0.2%) 1/1308 (0.1%)
ENDOMETRIAL CANCER 1/1296 (0.1%) 1/1308 (0.1%)
ENDOMETRIAL CANCER METASTATIC 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL STROMAL TUMOUR 0/1296 (0%) 1/1308 (0.1%)
HEPATIC NEOPLASM MALIGNANT RECURRENT 0/1296 (0%) 1/1308 (0.1%)
INTESTINAL ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
LUNG ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
LUNG CANCER METASTATIC 1/1296 (0.1%) 0/1308 (0%)
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV 0/1296 (0%) 1/1308 (0.1%)
LUNG NEOPLASM 1/1296 (0.1%) 0/1308 (0%)
LUNG NEOPLASM MALIGNANT 3/1296 (0.2%) 0/1308 (0%)
LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
MALIGNANT GLIOMA 0/1296 (0%) 1/1308 (0.1%)
MALIGNANT MELANOMA 1/1296 (0.1%) 1/1308 (0.1%)
MALIGNANT PLEURAL EFFUSION 0/1296 (0%) 1/1308 (0.1%)
MANTLE CELL LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
METASTASES TO CENTRAL NERVOUS SYSTEM 1/1296 (0.1%) 0/1308 (0%)
MUELLER'S MIXED TUMOUR 1/1296 (0.1%) 0/1308 (0%)
MULTIPLE MYELOMA 0/1296 (0%) 1/1308 (0.1%)
MYELODYSPLASTIC SYNDROME 2/1296 (0.2%) 0/1308 (0%)
NEOPLASM MALIGNANT 2/1296 (0.2%) 1/1308 (0.1%)
NEUROENDOCRINE CARCINOMA METASTATIC 1/1296 (0.1%) 0/1308 (0%)
NON-HODGKIN'S LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
OESOPHAGEAL CARCINOMA 0/1296 (0%) 2/1308 (0.2%)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED 0/1296 (0%) 1/1308 (0.1%)
OVARIAN CANCER METASTATIC 1/1296 (0.1%) 1/1308 (0.1%)
OVARIAN CANCER STAGE III 1/1296 (0.1%) 0/1308 (0%)
PANCREATIC CARCINOMA METASTATIC 0/1296 (0%) 2/1308 (0.2%)
PARATHYROID TUMOUR BENIGN 0/1296 (0%) 1/1308 (0.1%)
PLASMACYTOMA 1/1296 (0.1%) 0/1308 (0%)
PROSTATE CANCER 3/1296 (0.2%) 4/1308 (0.3%)
RENAL CELL CARCINOMA 0/1296 (0%) 1/1308 (0.1%)
SALIVARY GLAND CANCER 0/1296 (0%) 1/1308 (0.1%)
SALIVARY GLAND NEOPLASM 1/1296 (0.1%) 0/1308 (0%)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1/1296 (0.1%) 0/1308 (0%)
SQUAMOUS CELL CARCINOMA OF SKIN 0/1296 (0%) 1/1308 (0.1%)
TRANSITIONAL CELL CARCINOMA 1/1296 (0.1%) 0/1308 (0%)
URETERIC CANCER RECURRENT 1/1296 (0.1%) 0/1308 (0%)
Nervous system disorders
APHASIA 0/1296 (0%) 1/1308 (0.1%)
BRAIN INJURY 0/1296 (0%) 1/1308 (0.1%)
BRAIN MASS 0/1296 (0%) 1/1308 (0.1%)
CAROTID ARTERY STENOSIS 3/1296 (0.2%) 4/1308 (0.3%)
CARPAL TUNNEL SYNDROME 1/1296 (0.1%) 0/1308 (0%)
CENTRAL NERVOUS SYSTEM LESION 1/1296 (0.1%) 0/1308 (0%)
CEREBELLAR INFARCTION 0/1296 (0%) 2/1308 (0.2%)
CEREBRAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
CEREBROVASCULAR ACCIDENT 5/1296 (0.4%) 14/1308 (1.1%)
CERVICAL MYELOPATHY 1/1296 (0.1%) 0/1308 (0%)
CERVICOBRACHIAL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
COMPLICATED MIGRAINE 1/1296 (0.1%) 1/1308 (0.1%)
CONVULSION 0/1296 (0%) 2/1308 (0.2%)
CUBITAL TUNNEL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
DEPRESSED LEVEL OF CONSCIOUSNESS 1/1296 (0.1%) 0/1308 (0%)
DIZZINESS 1/1296 (0.1%) 1/1308 (0.1%)
EMBOLIC CEREBRAL INFARCTION 1/1296 (0.1%) 0/1308 (0%)
ENCEPHALOPATHY 2/1296 (0.2%) 2/1308 (0.2%)
EPILEPSY 0/1296 (0%) 1/1308 (0.1%)
GRAND MAL CONVULSION 2/1296 (0.2%) 1/1308 (0.1%)
HAEMORRHAGE INTRACRANIAL 1/1296 (0.1%) 1/1308 (0.1%)
HEADACHE 1/1296 (0.1%) 0/1308 (0%)
ISCHAEMIC STROKE 0/1296 (0%) 4/1308 (0.3%)
METABOLIC ENCEPHALOPATHY 2/1296 (0.2%) 0/1308 (0%)
MIGRAINE 1/1296 (0.1%) 0/1308 (0%)
MULTIPLE SCLEROSIS 0/1296 (0%) 1/1308 (0.1%)
PARTIAL SEIZURES 0/1296 (0%) 1/1308 (0.1%)
PRESYNCOPE 4/1296 (0.3%) 3/1308 (0.2%)
RADICULOPATHY 1/1296 (0.1%) 0/1308 (0%)
SCIATICA 1/1296 (0.1%) 0/1308 (0%)
SENSORY LOSS 0/1296 (0%) 1/1308 (0.1%)
SUBARACHNOID HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
SYNCOPE 5/1296 (0.4%) 5/1308 (0.4%)
TRANSIENT ISCHAEMIC ATTACK 5/1296 (0.4%) 2/1308 (0.2%)
TYPICAL AURA WITHOUT HEADACHE 1/1296 (0.1%) 0/1308 (0%)
ULNAR TUNNEL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS 0/1296 (0%) 1/1308 (0.1%)
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME 1/1296 (0.1%) 0/1308 (0%)
ANXIETY 0/1296 (0%) 2/1308 (0.2%)
COMPLETED SUICIDE 1/1296 (0.1%) 0/1308 (0%)
CONFUSIONAL STATE 1/1296 (0.1%) 0/1308 (0%)
CONVERSION DISORDER 1/1296 (0.1%) 0/1308 (0%)
DELIRIUM 1/1296 (0.1%) 0/1308 (0%)
DEPRESSION 1/1296 (0.1%) 1/1308 (0.1%)
DEPRESSION SUICIDAL 0/1296 (0%) 1/1308 (0.1%)
INTENTIONAL SELF-INJURY 0/1296 (0%) 1/1308 (0.1%)
MENTAL STATUS CHANGES 3/1296 (0.2%) 3/1308 (0.2%)
POST-TRAUMATIC AMNESTIC DISORDER 0/1296 (0%) 1/1308 (0.1%)
SOMATOFORM DISORDER 0/1296 (0%) 1/1308 (0.1%)
SUICIDAL IDEATION 1/1296 (0.1%) 0/1308 (0%)
SUICIDE ATTEMPT 0/1296 (0%) 1/1308 (0.1%)
Renal and urinary disorders
CALCULUS URETERIC 1/1296 (0.1%) 0/1308 (0%)
CYSTITIS HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
DYSURIA 2/1296 (0.2%) 0/1308 (0%)
HAEMATURIA 2/1296 (0.2%) 2/1308 (0.2%)
HYDRONEPHROSIS 1/1296 (0.1%) 0/1308 (0%)
NEPHROLITHIASIS 3/1296 (0.2%) 2/1308 (0.2%)
OBSTRUCTIVE UROPATHY 0/1296 (0%) 1/1308 (0.1%)
RENAL ARTERY STENOSIS 1/1296 (0.1%) 1/1308 (0.1%)
RENAL FAILURE 1/1296 (0.1%) 0/1308 (0%)
RENAL FAILURE ACUTE 9/1296 (0.7%) 9/1308 (0.7%)
RENAL FAILURE CHRONIC 0/1296 (0%) 1/1308 (0.1%)
RENAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
URINARY FISTULA 1/1296 (0.1%) 0/1308 (0%)
URINARY INCONTINENCE 0/1296 (0%) 2/1308 (0.2%)
URINARY RETENTION 0/1296 (0%) 1/1308 (0.1%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA 3/1296 (0.2%) 2/1308 (0.2%)
EPIDIDYMITIS 0/1296 (0%) 1/1308 (0.1%)
ERECTILE DYSFUNCTION 0/1296 (0%) 1/1308 (0.1%)
UTERINE POLYP 1/1296 (0.1%) 0/1308 (0%)
VAGINAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
VAGINAL PROLAPSE 1/1296 (0.1%) 1/1308 (0.1%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA 1/1296 (0.1%) 0/1308 (0%)
ACUTE RESPIRATORY FAILURE 6/1296 (0.5%) 5/1308 (0.4%)
ASTHMA 2/1296 (0.2%) 0/1308 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 7/1296 (0.5%) 9/1308 (0.7%)
DIAPHRAGMATIC PARALYSIS 1/1296 (0.1%) 0/1308 (0%)
DYSPNOEA 10/1296 (0.8%) 12/1308 (0.9%)
DYSPNOEA EXERTIONAL 6/1296 (0.5%) 4/1308 (0.3%)
EPISTAXIS 1/1296 (0.1%) 0/1308 (0%)
HYPOXIA 1/1296 (0.1%) 0/1308 (0%)
INTERSTITIAL LUNG DISEASE 1/1296 (0.1%) 0/1308 (0%)
PLEURAL EFFUSION 1/1296 (0.1%) 2/1308 (0.2%)
PLEURITIC PAIN 1/1296 (0.1%) 2/1308 (0.2%)
PNEUMONIA ASPIRATION 1/1296 (0.1%) 0/1308 (0%)
PNEUMOTHORAX 2/1296 (0.2%) 0/1308 (0%)
PULMONARY EMBOLISM 3/1296 (0.2%) 3/1308 (0.2%)
PULMONARY FIBROSIS 1/1296 (0.1%) 0/1308 (0%)
PULMONARY HYPERTENSION 0/1296 (0%) 1/1308 (0.1%)
PULMONARY OEDEMA 1/1296 (0.1%) 0/1308 (0%)
RESPIRATORY DISTRESS 2/1296 (0.2%) 0/1308 (0%)
RESPIRATORY FAILURE 6/1296 (0.5%) 2/1308 (0.2%)
SLEEP APNOEA SYNDROME 1/1296 (0.1%) 2/1308 (0.2%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA 0/1296 (0%) 1/1308 (0.1%)
DRY GANGRENE 0/1296 (0%) 1/1308 (0.1%)
PRECANCEROUS SKIN LESION 1/1296 (0.1%) 0/1308 (0%)
RASH 0/1296 (0%) 1/1308 (0.1%)
SCAR PAIN 0/1296 (0%) 1/1308 (0.1%)
Surgical and medical procedures
HIP ARTHROPLASTY 0/1296 (0%) 1/1308 (0.1%)
HYSTERECTOMY 1/1296 (0.1%) 0/1308 (0%)
PERCUTANEOUS CORONARY INTERVENTION 1/1296 (0.1%) 0/1308 (0%)
SPINAL FUSION SURGERY 0/1296 (0%) 1/1308 (0.1%)
SURGERY 0/1296 (0%) 1/1308 (0.1%)
Vascular disorders
ACCELERATED HYPERTENSION 0/1296 (0%) 1/1308 (0.1%)
ANEURYSM 0/1296 (0%) 1/1308 (0.1%)
AORTIC ANEURYSM 1/1296 (0.1%) 2/1308 (0.2%)
AORTIC DISSECTION 0/1296 (0%) 1/1308 (0.1%)
AORTIC STENOSIS 2/1296 (0.2%) 2/1308 (0.2%)
ARTERIAL DISORDER 1/1296 (0.1%) 0/1308 (0%)
ARTERIAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
ARTERIAL OCCLUSIVE DISEASE 1/1296 (0.1%) 0/1308 (0%)
ARTERIAL THROMBOSIS LIMB 0/1296 (0%) 1/1308 (0.1%)
ARTERIOSCLEROSIS 1/1296 (0.1%) 1/1308 (0.1%)
DEEP VEIN THROMBOSIS 1/1296 (0.1%) 3/1308 (0.2%)
EMBOLISM ARTERIAL 1/1296 (0.1%) 0/1308 (0%)
FEMORAL ARTERIAL STENOSIS 1/1296 (0.1%) 0/1308 (0%)
FEMORAL ARTERY ANEURYSM 1/1296 (0.1%) 1/1308 (0.1%)
FEMORAL ARTERY OCCLUSION 1/1296 (0.1%) 1/1308 (0.1%)
HAEMATOMA 1/1296 (0.1%) 0/1308 (0%)
HYPERTENSION 4/1296 (0.3%) 2/1308 (0.2%)
HYPERTENSIVE CRISIS 4/1296 (0.3%) 7/1308 (0.5%)
HYPERTENSIVE EMERGENCY 2/1296 (0.2%) 1/1308 (0.1%)
HYPOTENSION 1/1296 (0.1%) 2/1308 (0.2%)
INTERMITTENT CLAUDICATION 5/1296 (0.4%) 2/1308 (0.2%)
MALIGNANT HYPERTENSION 1/1296 (0.1%) 0/1308 (0%)
ORTHOSTATIC HYPOTENSION 3/1296 (0.2%) 2/1308 (0.2%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 2/1296 (0.2%) 12/1308 (0.9%)
PERIPHERAL VASCULAR DISORDER 1/1296 (0.1%) 2/1308 (0.2%)
VENOUS THROMBOSIS 0/1296 (0%) 1/1308 (0.1%)
Other (Not Including Serious) Adverse Events
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1110/1296 (85.6%) 1097/1308 (83.9%)
Blood and lymphatic system disorders
ANAEMIA 16/1296 (1.2%) 14/1308 (1.1%)
HAEMORRHAGIC ANAEMIA 0/1296 (0%) 3/1308 (0.2%)
HAEMORRHAGIC DIATHESIS 1/1296 (0.1%) 0/1308 (0%)
IRON DEFICIENCY ANAEMIA 5/1296 (0.4%) 8/1308 (0.6%)
LEUKOCYTOSIS 0/1296 (0%) 5/1308 (0.4%)
LYMPHADENOPATHY 1/1296 (0.1%) 1/1308 (0.1%)
NORMOCHROMIC NORMOCYTIC ANAEMIA 1/1296 (0.1%) 0/1308 (0%)
PANCYTOPENIA 0/1296 (0%) 1/1308 (0.1%)
SPLENIC GRANULOMA 0/1296 (0%) 1/1308 (0.1%)
THROMBOCYTOPENIA 2/1296 (0.2%) 0/1308 (0%)
Cardiac disorders
ACUTE CORONARY SYNDROME 8/1296 (0.6%) 4/1308 (0.3%)
ACUTE LEFT VENTRICULAR FAILURE 0/1296 (0%) 1/1308 (0.1%)
ACUTE MYOCARDIAL INFARCTION 22/1296 (1.7%) 26/1308 (2%)
ANGINA PECTORIS 281/1296 (21.7%) 272/1308 (20.8%)
ANGINA UNSTABLE 36/1296 (2.8%) 48/1308 (3.7%)
AORTIC VALVE INCOMPETENCE 1/1296 (0.1%) 0/1308 (0%)
AORTIC VALVE STENOSIS 0/1296 (0%) 2/1308 (0.2%)
ARRHYTHMIA 3/1296 (0.2%) 1/1308 (0.1%)
ARTERIOSCLEROSIS CORONARY ARTERY 3/1296 (0.2%) 1/1308 (0.1%)
ARTERIOSPASM CORONARY 0/1296 (0%) 3/1308 (0.2%)
ATRIAL FIBRILLATION 41/1296 (3.2%) 20/1308 (1.5%)
ATRIAL FLUTTER 1/1296 (0.1%) 2/1308 (0.2%)
ATRIOVENTRICULAR BLOCK 0/1296 (0%) 1/1308 (0.1%)
ATRIOVENTRICULAR BLOCK COMPLETE 2/1296 (0.2%) 2/1308 (0.2%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE 1/1296 (0.1%) 0/1308 (0%)
BRADYCARDIA 12/1296 (0.9%) 12/1308 (0.9%)
BUNDLE BRANCH BLOCK LEFT 1/1296 (0.1%) 2/1308 (0.2%)
CARDIAC ANEURYSM 1/1296 (0.1%) 0/1308 (0%)
CARDIAC ARREST 4/1296 (0.3%) 2/1308 (0.2%)
CARDIAC FAILURE 8/1296 (0.6%) 2/1308 (0.2%)
CARDIAC FAILURE ACUTE 3/1296 (0.2%) 2/1308 (0.2%)
CARDIAC FAILURE CHRONIC 5/1296 (0.4%) 2/1308 (0.2%)
CARDIAC FAILURE CONGESTIVE 16/1296 (1.2%) 15/1308 (1.1%)
CARDIAC FLUTTER 0/1296 (0%) 1/1308 (0.1%)
CARDIAC PERFORATION 1/1296 (0.1%) 0/1308 (0%)
CARDIO-RESPIRATORY ARREST 0/1296 (0%) 1/1308 (0.1%)
CARDIOGENIC SHOCK 5/1296 (0.4%) 0/1308 (0%)
CARDIOMYOPATHY 0/1296 (0%) 1/1308 (0.1%)
CARDIOVASCULAR DISORDER 1/1296 (0.1%) 0/1308 (0%)
CHRONOTROPIC INCOMPETENCE 0/1296 (0%) 1/1308 (0.1%)
CONGESTIVE CARDIOMYOPATHY 0/1296 (0%) 1/1308 (0.1%)
CORONARY ARTERY DISEASE 30/1296 (2.3%) 20/1308 (1.5%)
CORONARY ARTERY DISSECTION 91/1296 (7%) 63/1308 (4.8%)
CORONARY ARTERY EMBOLISM 1/1296 (0.1%) 1/1308 (0.1%)
CORONARY ARTERY OCCLUSION 4/1296 (0.3%) 3/1308 (0.2%)
CORONARY ARTERY PERFORATION 2/1296 (0.2%) 1/1308 (0.1%)
CORONARY ARTERY STENOSIS 7/1296 (0.5%) 4/1308 (0.3%)
CORONARY ARTERY THROMBOSIS 2/1296 (0.2%) 1/1308 (0.1%)
CYANOSIS 1/1296 (0.1%) 0/1308 (0%)
DIASTOLIC DYSFUNCTION 0/1296 (0%) 1/1308 (0.1%)
EXTRASYSTOLES 2/1296 (0.2%) 0/1308 (0%)
HEART VALVE INCOMPETENCE 0/1296 (0%) 1/1308 (0.1%)
HYPERTENSIVE HEART DISEASE 0/1296 (0%) 1/1308 (0.1%)
HYPERTROPHIC CARDIOMYOPATHY 1/1296 (0.1%) 0/1308 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS 1/1296 (0.1%) 0/1308 (0%)
INTRACARDIAC THROMBUS 1/1296 (0.1%) 0/1308 (0%)
ISCHAEMIC CARDIOMYOPATHY 2/1296 (0.2%) 5/1308 (0.4%)
LEFT VENTRICULAR DYSFUNCTION 0/1296 (0%) 1/1308 (0.1%)
MITRAL VALVE INCOMPETENCE 3/1296 (0.2%) 0/1308 (0%)
MITRAL VALVE PROLAPSE 1/1296 (0.1%) 0/1308 (0%)
MYOCARDIAL INFARCTION 42/1296 (3.2%) 29/1308 (2.2%)
MYOCARDIAL ISCHAEMIA 7/1296 (0.5%) 2/1308 (0.2%)
MYOPERICARDITIS 0/1296 (0%) 1/1308 (0.1%)
NODAL ARRHYTHMIA 0/1296 (0%) 2/1308 (0.2%)
PALPITATIONS 26/1296 (2%) 28/1308 (2.1%)
PERICARDIAL EFFUSION 1/1296 (0.1%) 2/1308 (0.2%)
PERICARDITIS 2/1296 (0.2%) 3/1308 (0.2%)
PRINZMETAL ANGINA 2/1296 (0.2%) 1/1308 (0.1%)
RESTRICTIVE CARDIOMYOPATHY 0/1296 (0%) 1/1308 (0.1%)
SICK SINUS SYNDROME 1/1296 (0.1%) 2/1308 (0.2%)
SINUS ARREST 1/1296 (0.1%) 0/1308 (0%)
SINUS BRADYCARDIA 4/1296 (0.3%) 3/1308 (0.2%)
SINUS TACHYCARDIA 2/1296 (0.2%) 0/1308 (0%)
SUPRAVENTRICULAR EXTRASYSTOLES 0/1296 (0%) 1/1308 (0.1%)
SUPRAVENTRICULAR TACHYCARDIA 4/1296 (0.3%) 6/1308 (0.5%)
TACHYARRHYTHMIA 1/1296 (0.1%) 0/1308 (0%)
TACHYCARDIA 4/1296 (0.3%) 4/1308 (0.3%)
VENTRICULAR ARRHYTHMIA 0/1296 (0%) 1/1308 (0.1%)
VENTRICULAR EXTRASYSTOLES 3/1296 (0.2%) 4/1308 (0.3%)
VENTRICULAR FIBRILLATION 5/1296 (0.4%) 1/1308 (0.1%)
VENTRICULAR TACHYCARDIA 13/1296 (1%) 8/1308 (0.6%)
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION 0/1296 (0%) 1/1308 (0.1%)
CONGENITAL ARTERIAL MALFORMATION 1/1296 (0.1%) 0/1308 (0%)
CORNEAL DYSTROPHY 1/1296 (0.1%) 0/1308 (0%)
HYDROCELE 1/1296 (0.1%) 1/1308 (0.1%)
PHIMOSIS 0/1296 (0%) 1/1308 (0.1%)
Ear and labyrinth disorders
CERUMEN IMPACTION 1/1296 (0.1%) 2/1308 (0.2%)
DEAFNESS 1/1296 (0.1%) 0/1308 (0%)
DEAFNESS UNILATERAL 1/1296 (0.1%) 1/1308 (0.1%)
EAR CONGESTION 1/1296 (0.1%) 0/1308 (0%)
EAR HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
EAR PAIN 1/1296 (0.1%) 1/1308 (0.1%)
EUSTACHIAN TUBE DYSFUNCTION 0/1296 (0%) 1/1308 (0.1%)
NEUROSENSORY HYPOACUSIS 1/1296 (0.1%) 0/1308 (0%)
TINNITUS 1/1296 (0.1%) 1/1308 (0.1%)
TYMPANIC MEMBRANE PERFORATION 1/1296 (0.1%) 0/1308 (0%)
VERTIGO 6/1296 (0.5%) 10/1308 (0.8%)
VERTIGO POSITIONAL 2/1296 (0.2%) 4/1308 (0.3%)
Endocrine disorders
ADRENAL MASS 0/1296 (0%) 1/1308 (0.1%)
CARCINOID SYNDROME 0/1296 (0%) 1/1308 (0.1%)
GOITRE 0/1296 (0%) 1/1308 (0.1%)
HYPERPARATHYROIDISM 0/1296 (0%) 1/1308 (0.1%)
HYPERTHYROIDISM 0/1296 (0%) 1/1308 (0.1%)
HYPOGONADISM 1/1296 (0.1%) 0/1308 (0%)
HYPOTHYROIDISM 1/1296 (0.1%) 3/1308 (0.2%)
SECONDARY HYPOGONADISM 1/1296 (0.1%) 0/1308 (0%)
THYROID MASS 0/1296 (0%) 1/1308 (0.1%)
Eye disorders
ABNORMAL SENSATION IN EYE 0/1296 (0%) 1/1308 (0.1%)
AMAUROSIS FUGAX 1/1296 (0.1%) 0/1308 (0%)
BLINDNESS 0/1296 (0%) 1/1308 (0.1%)
BLINDNESS TRANSIENT 0/1296 (0%) 1/1308 (0.1%)
CATARACT 6/1296 (0.5%) 6/1308 (0.5%)
CONJUNCTIVAL HAEMORRHAGE 0/1296 (0%) 2/1308 (0.2%)
CONJUNCTIVITIS 0/1296 (0%) 1/1308 (0.1%)
DIABETIC RETINOPATHY 0/1296 (0%) 1/1308 (0.1%)
DIPLOPIA 0/1296 (0%) 2/1308 (0.2%)
DRY EYE 0/1296 (0%) 1/1308 (0.1%)
EYE HAEMORRHAGE 2/1296 (0.2%) 2/1308 (0.2%)
EYE PAIN 1/1296 (0.1%) 0/1308 (0%)
GLAUCOMA 0/1296 (0%) 1/1308 (0.1%)
LACRIMAL DISORDER 1/1296 (0.1%) 0/1308 (0%)
MACULAR DEGENERATION 0/1296 (0%) 1/1308 (0.1%)
MACULAR FIBROSIS 0/1296 (0%) 1/1308 (0.1%)
MACULAR OEDEMA 0/1296 (0%) 1/1308 (0.1%)
OCULAR HYPERAEMIA 0/1296 (0%) 1/1308 (0.1%)
RETINAL ARTERY EMBOLISM 0/1296 (0%) 1/1308 (0.1%)
RETINAL DETACHMENT 0/1296 (0%) 3/1308 (0.2%)
RETINAL DISORDER 0/1296 (0%) 1/1308 (0.1%)
RETINAL TEAR 0/1296 (0%) 1/1308 (0.1%)
TOLOSA-HUNT SYNDROME 0/1296 (0%) 1/1308 (0.1%)
VISION BLURRED 2/1296 (0.2%) 5/1308 (0.4%)
VISUAL IMPAIRMENT 0/1296 (0%) 1/1308 (0.1%)
VITREOUS DETACHMENT 0/1296 (0%) 2/1308 (0.2%)
VITREOUS HAEMORRHAGE 0/1296 (0%) 2/1308 (0.2%)
Gastrointestinal disorders
ABDOMINAL DISCOMFORT 2/1296 (0.2%) 4/1308 (0.3%)
ABDOMINAL DISTENSION 1/1296 (0.1%) 1/1308 (0.1%)
ABDOMINAL HERNIA 2/1296 (0.2%) 0/1308 (0%)
ABDOMINAL PAIN 11/1296 (0.8%) 17/1308 (1.3%)
ABDOMINAL PAIN LOWER 1/1296 (0.1%) 3/1308 (0.2%)
ABDOMINAL PAIN UPPER 12/1296 (0.9%) 5/1308 (0.4%)
ANAL FISSURE 0/1296 (0%) 1/1308 (0.1%)
APPENDIX DISORDER 0/1296 (0%) 1/1308 (0.1%)
ASCITES 1/1296 (0.1%) 1/1308 (0.1%)
BARRETT'S OESOPHAGUS 0/1296 (0%) 2/1308 (0.2%)
BOWEL MOVEMENT IRREGULARITY 1/1296 (0.1%) 0/1308 (0%)
COLITIS 4/1296 (0.3%) 1/1308 (0.1%)
COLITIS ISCHAEMIC 0/1296 (0%) 1/1308 (0.1%)
COLITIS ULCERATIVE 1/1296 (0.1%) 0/1308 (0%)
COLONIC POLYP 1/1296 (0.1%) 6/1308 (0.5%)
CONSTIPATION 5/1296 (0.4%) 6/1308 (0.5%)
CROHN'S DISEASE 1/1296 (0.1%) 0/1308 (0%)
DENTAL CARIES 3/1296 (0.2%) 0/1308 (0%)
DIARRHOEA 16/1296 (1.2%) 15/1308 (1.1%)
DIVERTICULITIS INTESTINAL HAEMORRHAGIC 0/1296 (0%) 3/1308 (0.2%)
DIVERTICULUM 1/1296 (0.1%) 2/1308 (0.2%)
DIVERTICULUM INTESTINAL 2/1296 (0.2%) 5/1308 (0.4%)
DIVERTICULUM INTESTINAL HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
DUODENAL ULCER 0/1296 (0%) 1/1308 (0.1%)
DUODENAL ULCER PERFORATION 1/1296 (0.1%) 0/1308 (0%)
DYSPEPSIA 10/1296 (0.8%) 11/1308 (0.8%)
DYSPHAGIA 3/1296 (0.2%) 2/1308 (0.2%)
ENTERITIS 0/1296 (0%) 1/1308 (0.1%)
ENTEROCOLITIS HAEMORRHAGIC 0/1296 (0%) 1/1308 (0.1%)
EPIGASTRIC DISCOMFORT 0/1296 (0%) 1/1308 (0.1%)
ERUCTATION 0/1296 (0%) 1/1308 (0.1%)
FAECALOMA 0/1296 (0%) 1/1308 (0.1%)
FAECES DISCOLOURED 2/1296 (0.2%) 1/1308 (0.1%)
FLATULENCE 0/1296 (0%) 2/1308 (0.2%)
FOOD POISONING 0/1296 (0%) 1/1308 (0.1%)
GASTRIC DISORDER 0/1296 (0%) 1/1308 (0.1%)
GASTRIC POLYPS 1/1296 (0.1%) 0/1308 (0%)
GASTRIC ULCER 1/1296 (0.1%) 2/1308 (0.2%)
GASTRIC ULCER HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
GASTRITIS 6/1296 (0.5%) 8/1308 (0.6%)
GASTRITIS EROSIVE 1/1296 (0.1%) 2/1308 (0.2%)
GASTRITIS HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
GASTROINTESTINAL HAEMORRHAGE 9/1296 (0.7%) 11/1308 (0.8%)
GASTROINTESTINAL MOTILITY DISORDER 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL MUCOSAL DISORDER 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL ULCER HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
GASTROOESOPHAGEAL REFLUX DISEASE 15/1296 (1.2%) 15/1308 (1.1%)
GINGIVAL BLEEDING 2/1296 (0.2%) 2/1308 (0.2%)
GINGIVAL DISORDER 1/1296 (0.1%) 0/1308 (0%)
HAEMATEMESIS 0/1296 (0%) 2/1308 (0.2%)
HAEMATOCHEZIA 5/1296 (0.4%) 3/1308 (0.2%)
HAEMORRHOIDAL HAEMORRHAGE 0/1296 (0%) 3/1308 (0.2%)
HAEMORRHOIDS 1/1296 (0.1%) 4/1308 (0.3%)
HIATUS HERNIA 3/1296 (0.2%) 3/1308 (0.2%)
ILEUS 1/1296 (0.1%) 0/1308 (0%)
IMPAIRED GASTRIC EMPTYING 1/1296 (0.1%) 1/1308 (0.1%)
INGUINAL HERNIA 6/1296 (0.5%) 5/1308 (0.4%)
INTESTINAL MASS 1/1296 (0.1%) 0/1308 (0%)
LIP HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
LIP SWELLING 0/1296 (0%) 1/1308 (0.1%)
LOWER GASTROINTESTINAL HAEMORRHAGE 2/1296 (0.2%) 1/1308 (0.1%)
MALLORY-WEISS SYNDROME 0/1296 (0%) 1/1308 (0.1%)
MELAENA 1/1296 (0.1%) 2/1308 (0.2%)
MELANOSIS COLI 0/1296 (0%) 1/1308 (0.1%)
MOUTH HAEMORRHAGE 1/1296 (0.1%) 1/1308 (0.1%)
MOUTH ULCERATION 1/1296 (0.1%) 0/1308 (0%)
NAUSEA 30/1296 (2.3%) 29/1308 (2.2%)
ODYNOPHAGIA 1/1296 (0.1%) 0/1308 (0%)
OESOPHAGEAL HYPOMOTILITY 1/1296 (0.1%) 0/1308 (0%)
OESOPHAGEAL SPASM 0/1296 (0%) 1/1308 (0.1%)
OESOPHAGEAL STENOSIS 1/1296 (0.1%) 0/1308 (0%)
ORAL MUCOSAL DISCOLOURATION 0/1296 (0%) 1/1308 (0.1%)
PANCREATITIS 0/1296 (0%) 3/1308 (0.2%)
PANCREATITIS ACUTE 0/1296 (0%) 3/1308 (0.2%)
PANCREATITIS CHRONIC 0/1296 (0%) 1/1308 (0.1%)
PARAESTHESIA ORAL 1/1296 (0.1%) 1/1308 (0.1%)
POLYP COLORECTAL 0/1296 (0%) 1/1308 (0.1%)
PROCTITIS 1/1296 (0.1%) 1/1308 (0.1%)
PROCTITIS ULCERATIVE 0/1296 (0%) 1/1308 (0.1%)
RECTAL HAEMORRHAGE 6/1296 (0.5%) 7/1308 (0.5%)
RECTAL POLYP 1/1296 (0.1%) 0/1308 (0%)
RETROPERITONEAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
SALIVARY GLAND MASS 1/1296 (0.1%) 0/1308 (0%)
SMALL INTESTINAL OBSTRUCTION 3/1296 (0.2%) 4/1308 (0.3%)
SPIGELIAN HERNIA 1/1296 (0.1%) 2/1308 (0.2%)
STOMACH MASS 1/1296 (0.1%) 0/1308 (0%)
STOMATITIS 1/1296 (0.1%) 1/1308 (0.1%)
SWOLLEN TONGUE 1/1296 (0.1%) 0/1308 (0%)
TOOTH DISORDER 0/1296 (0%) 2/1308 (0.2%)
TOOTH LOSS 1/1296 (0.1%) 0/1308 (0%)
TOOTHACHE 2/1296 (0.2%) 2/1308 (0.2%)
UMBILICAL HERNIA 1/1296 (0.1%) 4/1308 (0.3%)
UPPER GASTROINTESTINAL HAEMORRHAGE 3/1296 (0.2%) 0/1308 (0%)
VOLVULUS 1/1296 (0.1%) 0/1308 (0%)
VOMITING 2/1296 (0.2%) 4/1308 (0.3%)
General disorders
ADVERSE DRUG REACTION 80/1296 (6.2%) 76/1308 (5.8%)
ASTHENIA 21/1296 (1.6%) 17/1308 (1.3%)
AXILLARY PAIN 0/1296 (0%) 1/1308 (0.1%)
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE 3/1296 (0.2%) 0/1308 (0%)
CATHETER SITE HAEMATOMA 26/1296 (2%) 32/1308 (2.4%)
CATHETER SITE HAEMORRHAGE 8/1296 (0.6%) 16/1308 (1.2%)
CATHETER SITE NECROSIS 0/1296 (0%) 1/1308 (0.1%)
CATHETER SITE PAIN 9/1296 (0.7%) 21/1308 (1.6%)
CATHETER SITE RASH 1/1296 (0.1%) 0/1308 (0%)
CATHETER SITE RELATED REACTION 0/1296 (0%) 3/1308 (0.2%)
CATHETER SITE SWELLING 2/1296 (0.2%) 1/1308 (0.1%)
CHEST DISCOMFORT 46/1296 (3.5%) 50/1308 (3.8%)
CHEST PAIN 84/1296 (6.5%) 90/1308 (6.9%)
COMPLICATION OF DEVICE REMOVAL 1/1296 (0.1%) 0/1308 (0%)
CYST 0/1296 (0%) 6/1308 (0.5%)
DEATH 1/1296 (0.1%) 4/1308 (0.3%)
DEVICE FAILURE 1/1296 (0.1%) 1/1308 (0.1%)
DEVICE ISSUE 1/1296 (0.1%) 1/1308 (0.1%)
DEVICE LEAD DAMAGE 0/1296 (0%) 1/1308 (0.1%)
DEVICE MALFUNCTION 1/1296 (0.1%) 0/1308 (0%)
DEVICE OCCLUSION 1/1296 (0.1%) 1/1308 (0.1%)
DRUG INTOLERANCE 2/1296 (0.2%) 1/1308 (0.1%)
EARLY SATIETY 0/1296 (0%) 1/1308 (0.1%)
FACIAL PAIN 0/1296 (0%) 1/1308 (0.1%)
FATIGUE 42/1296 (3.2%) 41/1308 (3.1%)
FEELING COLD 1/1296 (0.1%) 0/1308 (0%)
FEELING HOT 0/1296 (0%) 1/1308 (0.1%)
GENERAL PHYSICAL HEALTH DETERIORATION 1/1296 (0.1%) 0/1308 (0%)
GENERALISED OEDEMA 1/1296 (0.1%) 1/1308 (0.1%)
GRANULOMA 2/1296 (0.2%) 0/1308 (0%)
IMPAIRED HEALING 1/1296 (0.1%) 2/1308 (0.2%)
INFLAMMATION 1/1296 (0.1%) 0/1308 (0%)
INFLUENZA LIKE ILLNESS 1/1296 (0.1%) 0/1308 (0%)
INFUSION SITE PAIN 0/1296 (0%) 1/1308 (0.1%)
LOCAL SWELLING 0/1296 (0%) 1/1308 (0.1%)
MALAISE 9/1296 (0.7%) 9/1308 (0.7%)
MEDICAL DEVICE SITE REACTION 1/1296 (0.1%) 0/1308 (0%)
NON-CARDIAC CHEST PAIN 184/1296 (14.2%) 225/1308 (17.2%)
OEDEMA 0/1296 (0%) 3/1308 (0.2%)
OEDEMA PERIPHERAL 23/1296 (1.8%) 17/1308 (1.3%)
PACEMAKER GENERATED ARRHYTHMIA 1/1296 (0.1%) 0/1308 (0%)
PAIN 1/1296 (0.1%) 7/1308 (0.5%)
PATIENT-DEVICE INCOMPATIBILITY 1/1296 (0.1%) 0/1308 (0%)
PYREXIA 4/1296 (0.3%) 3/1308 (0.2%)
SENSATION OF FOREIGN BODY 1/1296 (0.1%) 1/1308 (0.1%)
SPINAL PAIN 1/1296 (0.1%) 0/1308 (0%)
SWELLING 0/1296 (0%) 1/1308 (0.1%)
THROMBOSIS IN DEVICE 9/1296 (0.7%) 6/1308 (0.5%)
ULCER 0/1296 (0%) 1/1308 (0.1%)
UNEVALUABLE EVENT 1/1296 (0.1%) 0/1308 (0%)
VESSEL PUNCTURE SITE HAEMATOMA 1/1296 (0.1%) 0/1308 (0%)
VESSEL PUNCTURE SITE THROMBOSIS 0/1296 (0%) 1/1308 (0.1%)
Hepatobiliary disorders
ACUTE HEPATIC FAILURE 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT OBSTRUCTION 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT STONE 0/1296 (0%) 3/1308 (0.2%)
BILIARY DILATATION 0/1296 (0%) 1/1308 (0.1%)
CHOLANGITIS 1/1296 (0.1%) 0/1308 (0%)
CHOLANGITIS ACUTE 1/1296 (0.1%) 0/1308 (0%)
CHOLECYSTITIS 3/1296 (0.2%) 2/1308 (0.2%)
CHOLECYSTITIS ACUTE 1/1296 (0.1%) 1/1308 (0.1%)
CHOLECYSTITIS CHRONIC 0/1296 (0%) 1/1308 (0.1%)
CHOLELITHIASIS 5/1296 (0.4%) 4/1308 (0.3%)
GALLBLADDER DISORDER 1/1296 (0.1%) 1/1308 (0.1%)
GRANULOMATOUS LIVER DISEASE 0/1296 (0%) 1/1308 (0.1%)
HEPATIC CIRRHOSIS 0/1296 (0%) 1/1308 (0.1%)
HEPATIC CYST 1/1296 (0.1%) 2/1308 (0.2%)
HEPATIC FUNCTION ABNORMAL 1/1296 (0.1%) 0/1308 (0%)
HEPATIC LESION 0/1296 (0%) 1/1308 (0.1%)
HEPATIC PAIN 0/1296 (0%) 1/1308 (0.1%)
HEPATIC STEATOSIS 2/1296 (0.2%) 1/1308 (0.1%)
ISCHAEMIC HEPATITIS 1/1296 (0.1%) 0/1308 (0%)
JAUNDICE 1/1296 (0.1%) 0/1308 (0%)
Immune system disorders
ALLERGY TO ARTHROPOD BITE 0/1296 (0%) 1/1308 (0.1%)
ALLERGY TO ARTHROPOD STING 1/1296 (0.1%) 0/1308 (0%)
ANAPHYLACTIC REACTION 1/1296 (0.1%) 0/1308 (0%)
CONTRAST MEDIA ALLERGY 1/1296 (0.1%) 1/1308 (0.1%)
DRUG HYPERSENSITIVITY 4/1296 (0.3%) 2/1308 (0.2%)
FOOD ALLERGY 0/1296 (0%) 1/1308 (0.1%)
HYPERSENSITIVITY 0/1296 (0%) 1/1308 (0.1%)
SARCOIDOSIS 0/1296 (0%) 1/1308 (0.1%)
SEASONAL ALLERGY 1/1296 (0.1%) 1/1308 (0.1%)
Infections and infestations
ABSCESS LIMB 1/1296 (0.1%) 1/1308 (0.1%)
ABSCESS NECK 1/1296 (0.1%) 0/1308 (0%)
ABSCESS ORAL 0/1296 (0%) 1/1308 (0.1%)
ACARODERMATITIS 1/1296 (0.1%) 1/1308 (0.1%)
ACUTE SINUSITIS 5/1296 (0.4%) 5/1308 (0.4%)
APPENDICITIS 3/1296 (0.2%) 4/1308 (0.3%)
ARTERIOVENOUS GRAFT SITE INFECTION 0/1296 (0%) 1/1308 (0.1%)
ARTHRITIS INFECTIVE 1/1296 (0.1%) 0/1308 (0%)
BACTERAEMIA 0/1296 (0%) 1/1308 (0.1%)
BACTERIAL INFECTION 1/1296 (0.1%) 0/1308 (0%)
BACTERIAL SEPSIS 0/1296 (0%) 1/1308 (0.1%)
BODY TINEA 1/1296 (0.1%) 0/1308 (0%)
BRONCHITIS 19/1296 (1.5%) 19/1308 (1.5%)
BRONCHITIS VIRAL 0/1296 (0%) 3/1308 (0.2%)
BRONCHOPNEUMONIA 0/1296 (0%) 1/1308 (0.1%)
BURSITIS INFECTIVE 1/1296 (0.1%) 0/1308 (0%)
CAMPYLOBACTER INFECTION 0/1296 (0%) 1/1308 (0.1%)
CATHETER SITE ABSCESS 0/1296 (0%) 1/1308 (0.1%)
CATHETER SITE CELLULITIS 1/1296 (0.1%) 1/1308 (0.1%)
CELLULITIS 10/1296 (0.8%) 10/1308 (0.8%)
CHOLECYSTITIS INFECTIVE 0/1296 (0%) 1/1308 (0.1%)
CHRONIC SINUSITIS 0/1296 (0%) 2/1308 (0.2%)
CLOSTRIDIAL INFECTION 1/1296 (0.1%) 2/1308 (0.2%)
CLOSTRIDIUM COLITIS 0/1296 (0%) 1/1308 (0.1%)
CONJUNCTIVITIS BACTERIAL 1/1296 (0.1%) 0/1308 (0%)
CYSTITIS 1/1296 (0.1%) 2/1308 (0.2%)
DIABETIC FOOT INFECTION 1/1296 (0.1%) 0/1308 (0%)
DIVERTICULITIS 12/1296 (0.9%) 10/1308 (0.8%)
EAR INFECTION 1/1296 (0.1%) 2/1308 (0.2%)
EMPYEMA 0/1296 (0%) 1/1308 (0.1%)
ENDOMETRITIS 1/1296 (0.1%) 0/1308 (0%)
EPIDEMIC POLYARTHRITIS 1/1296 (0.1%) 0/1308 (0%)
ESCHERICHIA BACTERAEMIA 1/1296 (0.1%) 0/1308 (0%)
ESCHERICHIA INFECTION 1/1296 (0.1%) 0/1308 (0%)
ESCHERICHIA SEPSIS 0/1296 (0%) 1/1308 (0.1%)
ESCHERICHIA URINARY TRACT INFECTION 0/1296 (0%) 2/1308 (0.2%)
EXTRADURAL ABSCESS 0/1296 (0%) 1/1308 (0.1%)
FURUNCLE 0/1296 (0%) 1/1308 (0.1%)
GANGRENE 1/1296 (0.1%) 0/1308 (0%)
GASTRITIS VIRAL 1/1296 (0.1%) 0/1308 (0%)
GASTROENTERITIS 2/1296 (0.2%) 8/1308 (0.6%)
GASTROENTERITIS VIRAL 2/1296 (0.2%) 1/1308 (0.1%)
GASTROINTESTINAL INFECTION 1/1296 (0.1%) 0/1308 (0%)
GENITAL HERPES 1/1296 (0.1%) 1/1308 (0.1%)
HELICOBACTER INFECTION 1/1296 (0.1%) 2/1308 (0.2%)
HERPES SIMPLEX 0/1296 (0%) 1/1308 (0.1%)
HERPES ZOSTER 5/1296 (0.4%) 7/1308 (0.5%)
IMPETIGO 0/1296 (0%) 1/1308 (0.1%)
INFECTED BITES 2/1296 (0.2%) 0/1308 (0%)
INFECTED CYST 0/1296 (0%) 1/1308 (0.1%)
INFECTIOUS PLEURAL EFFUSION 1/1296 (0.1%) 0/1308 (0%)
INFLUENZA 10/1296 (0.8%) 16/1308 (1.2%)
INTERTRIGO CANDIDA 0/1296 (0%) 1/1308 (0.1%)
KIDNEY INFECTION 0/1296 (0%) 1/1308 (0.1%)
LABYRINTHITIS 0/1296 (0%) 1/1308 (0.1%)
LARYNGITIS 1/1296 (0.1%) 0/1308 (0%)
LIVER ABSCESS 1/1296 (0.1%) 0/1308 (0%)
LOBAR PNEUMONIA 4/1296 (0.3%) 3/1308 (0.2%)
LOCALISED INFECTION 2/1296 (0.2%) 0/1308 (0%)
LOWER RESPIRATORY TRACT INFECTION 2/1296 (0.2%) 3/1308 (0.2%)
LUNG INFECTION PSEUDOMONAL 0/1296 (0%) 1/1308 (0.1%)
LYME DISEASE 0/1296 (0%) 1/1308 (0.1%)
LYMPH GLAND INFECTION 1/1296 (0.1%) 0/1308 (0%)
MYRINGITIS BULLOUS 1/1296 (0.1%) 0/1308 (0%)
NASOPHARYNGITIS 9/1296 (0.7%) 12/1308 (0.9%)
NECROTISING FASCIITIS 0/1296 (0%) 1/1308 (0.1%)
OESOPHAGEAL CANDIDIASIS 0/1296 (0%) 2/1308 (0.2%)
ORAL CANDIDIASIS 1/1296 (0.1%) 0/1308 (0%)
ORAL FUNGAL INFECTION 0/1296 (0%) 1/1308 (0.1%)
ORCHITIS 1/1296 (0.1%) 0/1308 (0%)
OSTEOMYELITIS 0/1296 (0%) 1/1308 (0.1%)
OTITIS EXTERNA 1/1296 (0.1%) 0/1308 (0%)
OTITIS MEDIA 0/1296 (0%) 1/1308 (0.1%)
OTITIS MEDIA ACUTE 1/1296 (0.1%) 0/1308 (0%)
OTITIS MEDIA CHRONIC 1/1296 (0.1%) 0/1308 (0%)
PELVIC INFECTION 1/1296 (0.1%) 0/1308 (0%)
PHARYNGITIS 0/1296 (0%) 2/1308 (0.2%)
PHARYNGITIS BACTERIAL 1/1296 (0.1%) 0/1308 (0%)
PHARYNGITIS STREPTOCOCCAL 0/1296 (0%) 2/1308 (0.2%)
PNEUMONIA 18/1296 (1.4%) 21/1308 (1.6%)
PNEUMONIA ESCHERICHIA 1/1296 (0.1%) 0/1308 (0%)
POSTOPERATIVE WOUND INFECTION 2/1296 (0.2%) 0/1308 (0%)
PYELONEPHRITIS 2/1296 (0.2%) 3/1308 (0.2%)
PYELONEPHRITIS ACUTE 1/1296 (0.1%) 0/1308 (0%)
RESPIRATORY TRACT INFECTION 2/1296 (0.2%) 2/1308 (0.2%)
RESPIRATORY TRACT INFECTION VIRAL 1/1296 (0.1%) 1/1308 (0.1%)
SCROTAL ABSCESS 1/1296 (0.1%) 0/1308 (0%)
SEPSIS 9/1296 (0.7%) 5/1308 (0.4%)
SEPTIC SHOCK 1/1296 (0.1%) 1/1308 (0.1%)
SIALOADENITIS 0/1296 (0%) 1/1308 (0.1%)
SINOBRONCHITIS 0/1296 (0%) 1/1308 (0.1%)
SINUSITIS 11/1296 (0.8%) 10/1308 (0.8%)
SINUSITIS BACTERIAL 2/1296 (0.2%) 0/1308 (0%)
SKIN INFECTION 0/1296 (0%) 1/1308 (0.1%)
STAPHYLOCOCCAL ABSCESS 0/1296 (0%) 1/1308 (0.1%)
STAPHYLOCOCCAL INFECTION 1/1296 (0.1%) 0/1308 (0%)
STAPHYLOCOCCAL SEPSIS 0/1296 (0%) 1/1308 (0.1%)
SUBCUTANEOUS ABSCESS 0/1296 (0%) 2/1308 (0.2%)
TOOTH ABSCESS 3/1296 (0.2%) 4/1308 (0.3%)
TOOTH INFECTION 3/1296 (0.2%) 5/1308 (0.4%)
TRICHOMONIASIS 1/1296 (0.1%) 0/1308 (0%)
UPPER RESPIRATORY TRACT INFECTION 18/1296 (1.4%) 20/1308 (1.5%)
UPPER RESPIRATORY TRACT INFECTION BACTERIAL 0/1296 (0%) 1/1308 (0.1%)
URINARY TRACT INFECTION 12/1296 (0.9%) 21/1308 (1.6%)
UROSEPSIS 0/1296 (0%) 1/1308 (0.1%)
VAGINITIS BACTERIAL 1/1296 (0.1%) 0/1308 (0%)
VIRAL INFECTION 2/1296 (0.2%) 1/1308 (0.1%)
VIRAL LABYRINTHITIS 1/1296 (0.1%) 0/1308 (0%)
VIRAL UPPER RESPIRATORY TRACT INFECTION 1/1296 (0.1%) 1/1308 (0.1%)
WOUND INFECTION 2/1296 (0.2%) 2/1308 (0.2%)
WOUND INFECTION BACTERIAL 1/1296 (0.1%) 0/1308 (0%)
WOUND INFECTION STAPHYLOCOCCAL 0/1296 (0%) 1/1308 (0.1%)
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE 0/1296 (0%) 2/1308 (0.2%)
ACETABULUM FRACTURE 1/1296 (0.1%) 0/1308 (0%)
ANAEMIA POSTOPERATIVE 2/1296 (0.2%) 1/1308 (0.1%)
ANASTOMOTIC ULCER HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
ANIMAL BITE 0/1296 (0%) 4/1308 (0.3%)
ANKLE FRACTURE 2/1296 (0.2%) 5/1308 (0.4%)
ARTHROPOD BITE 2/1296 (0.2%) 1/1308 (0.1%)
ARTHROPOD STING 1/1296 (0.1%) 0/1308 (0%)
AXILLARY NERVE INJURY 1/1296 (0.1%) 0/1308 (0%)
BACK INJURY 1/1296 (0.1%) 1/1308 (0.1%)
CARDIAC PROCEDURE COMPLICATION 7/1296 (0.5%) 3/1308 (0.2%)
CATHETER SITE HAEMATOMA 3/1296 (0.2%) 5/1308 (0.4%)
CERVICAL VERTEBRAL FRACTURE 2/1296 (0.2%) 0/1308 (0%)
COMMINUTED FRACTURE 0/1296 (0%) 1/1308 (0.1%)
CONFUSION POSTOPERATIVE 2/1296 (0.2%) 0/1308 (0%)
CONTRAST MEDIA ALLERGY 1/1296 (0.1%) 0/1308 (0%)
CONTUSION 15/1296 (1.2%) 19/1308 (1.5%)
CORNEAL ABRASION 1/1296 (0.1%) 0/1308 (0%)
CORONARY ARTERY RESTENOSIS 33/1296 (2.5%) 20/1308 (1.5%)
CRANIOCEREBRAL INJURY 2/1296 (0.2%) 1/1308 (0.1%)
CYSTITIS RADIATION 0/1296 (0%) 1/1308 (0.1%)
DEPRESSION POSTOPERATIVE 0/1296 (0%) 1/1308 (0.1%)
DRUG ADMINISTRATION ERROR 0/1296 (0%) 1/1308 (0.1%)
EAR INJURY 1/1296 (0.1%) 0/1308 (0%)
EPICONDYLITIS 0/1296 (0%) 1/1308 (0.1%)
EXCORIATION 0/1296 (0%) 2/1308 (0.2%)
EXPOSURE TO TOXIC AGENT 0/1296 (0%) 1/1308 (0.1%)
EYE PENETRATION 0/1296 (0%) 1/1308 (0.1%)
FACIAL BONES FRACTURE 1/1296 (0.1%) 0/1308 (0%)
FALL 12/1296 (0.9%) 15/1308 (1.1%)
FEMUR FRACTURE 1/1296 (0.1%) 0/1308 (0%)
FIBULA FRACTURE 1/1296 (0.1%) 1/1308 (0.1%)
FOOT FRACTURE 2/1296 (0.2%) 6/1308 (0.5%)
FOREARM FRACTURE 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL DISORDER POSTOPERATIVE 0/1296 (0%) 1/1308 (0.1%)
GASTROINTESTINAL STOMA COMPLICATION 1/1296 (0.1%) 0/1308 (0%)
HAND FRACTURE 0/1296 (0%) 1/1308 (0.1%)
HEAD INJURY 0/1296 (0%) 1/1308 (0.1%)
HEAT EXHAUSTION 1/1296 (0.1%) 0/1308 (0%)
HIP FRACTURE 0/1296 (0%) 1/1308 (0.1%)
HUMERUS FRACTURE 1/1296 (0.1%) 0/1308 (0%)
IN-STENT ARTERIAL RESTENOSIS 2/1296 (0.2%) 0/1308 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS 6/1296 (0.5%) 9/1308 (0.7%)
INCISION SITE PAIN 1/1296 (0.1%) 1/1308 (0.1%)
INCORRECT DOSE ADMINISTERED 2/1296 (0.2%) 0/1308 (0%)
INJURY 2/1296 (0.2%) 1/1308 (0.1%)
JOINT DISLOCATION 0/1296 (0%) 2/1308 (0.2%)
JOINT INJURY 2/1296 (0.2%) 4/1308 (0.3%)
LACERATION 9/1296 (0.7%) 10/1308 (0.8%)
LIGAMENT RUPTURE 1/1296 (0.1%) 0/1308 (0%)
LIGAMENT SPRAIN 5/1296 (0.4%) 5/1308 (0.4%)
LIMB INJURY 2/1296 (0.2%) 3/1308 (0.2%)
LUMBAR VERTEBRAL FRACTURE 0/1296 (0%) 1/1308 (0.1%)
MOUTH INJURY 0/1296 (0%) 2/1308 (0.2%)
MUSCLE RUPTURE 2/1296 (0.2%) 0/1308 (0%)
MUSCLE STRAIN 2/1296 (0.2%) 3/1308 (0.2%)
OVERDOSE 1/1296 (0.1%) 1/1308 (0.1%)
PATELLA FRACTURE 0/1296 (0%) 1/1308 (0.1%)
PELVIC FRACTURE 0/1296 (0%) 1/1308 (0.1%)
PELVIC ORGAN INJURY 0/1296 (0%) 1/1308 (0.1%)
PERIPROSTHETIC FRACTURE 1/1296 (0.1%) 0/1308 (0%)
PLAQUE SHIFT 3/1296 (0.2%) 4/1308 (0.3%)
POISONING 0/1296 (0%) 1/1308 (0.1%)
POISONING DELIBERATE 0/1296 (0%) 1/1308 (0.1%)
POST PROCEDURAL COMPLICATION 1/1296 (0.1%) 1/1308 (0.1%)
POST PROCEDURAL DISCOMFORT 1/1296 (0.1%) 1/1308 (0.1%)
POST PROCEDURAL HAEMATOMA 1/1296 (0.1%) 0/1308 (0%)
POST PROCEDURAL HAEMATURIA 1/1296 (0.1%) 0/1308 (0%)
POST PROCEDURAL MYOCARDIAL INFARCTION 20/1296 (1.5%) 13/1308 (1%)
POST PROCEDURAL OEDEMA 1/1296 (0.1%) 0/1308 (0%)
POST-TRAUMATIC PAIN 7/1296 (0.5%) 8/1308 (0.6%)
POSTOPERATIVE FEVER 2/1296 (0.2%) 1/1308 (0.1%)
POSTOPERATIVE HERNIA 0/1296 (0%) 1/1308 (0.1%)
POSTOPERATIVE ILEUS 1/1296 (0.1%) 0/1308 (0%)
POSTOPERATIVE RESPIRATORY DISTRESS 1/1296 (0.1%) 0/1308 (0%)
PROCEDURAL COMPLICATION 2/1296 (0.2%) 0/1308 (0%)
PROCEDURAL DIZZINESS 2/1296 (0.2%) 0/1308 (0%)
PROCEDURAL HAEMORRHAGE 2/1296 (0.2%) 0/1308 (0%)
PROCEDURAL HEADACHE 3/1296 (0.2%) 4/1308 (0.3%)
PROCEDURAL HYPERTENSION 5/1296 (0.4%) 5/1308 (0.4%)
PROCEDURAL HYPOTENSION 10/1296 (0.8%) 2/1308 (0.2%)
PROCEDURAL NAUSEA 8/1296 (0.6%) 6/1308 (0.5%)
PROCEDURAL PAIN 14/1296 (1.1%) 14/1308 (1.1%)
PROCEDURAL VOMITING 1/1296 (0.1%) 3/1308 (0.2%)
RADIUS FRACTURE 0/1296 (0%) 1/1308 (0.1%)
RIB FRACTURE 4/1296 (0.3%) 2/1308 (0.2%)
ROAD TRAFFIC ACCIDENT 5/1296 (0.4%) 4/1308 (0.3%)
SEROMA 0/1296 (0%) 1/1308 (0.1%)
SPINAL COMPRESSION FRACTURE 1/1296 (0.1%) 1/1308 (0.1%)
SPINAL FRACTURE 1/1296 (0.1%) 0/1308 (0%)
STAB WOUND 0/1296 (0%) 1/1308 (0.1%)
SUBDURAL HAEMATOMA 0/1296 (0%) 3/1308 (0.2%)
SUTURE RUPTURE 0/1296 (0%) 1/1308 (0.1%)
TENDON RUPTURE 2/1296 (0.2%) 0/1308 (0%)
THERMAL BURN 2/1296 (0.2%) 0/1308 (0%)
THORACIC VERTEBRAL FRACTURE 0/1296 (0%) 1/1308 (0.1%)
TOOTH FRACTURE 1/1296 (0.1%) 3/1308 (0.2%)
TRAUMATIC HAEMATOMA 1/1296 (0.1%) 2/1308 (0.2%)
TRAUMATIC HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
TRAUMATIC INTRACRANIAL HAEMORRHAGE 1/1296 (0.1%) 0/1308 (0%)
TRAUMATIC LUNG INJURY 0/1296 (0%) 1/1308 (0.1%)
UPPER LIMB FRACTURE 0/1296 (0%) 1/1308 (0.1%)
URINARY RETENTION POSTOPERATIVE 3/1296 (0.2%) 1/1308 (0.1%)
VASCULAR GRAFT COMPLICATION 0/1296 (0%) 1/1308 (0.1%)
VASCULAR GRAFT OCCLUSION 0/1296 (0%) 1/1308 (0.1%)
VASCULAR PSEUDOANEURYSM 6/1296 (0.5%) 7/1308 (0.5%)
WOUND COMPLICATION 1/1296 (0.1%) 1/1308 (0.1%)
WOUND DEHISCENCE 0/1296 (0%) 1/1308 (0.1%)
WOUND HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
WRIST FRACTURE 1/1296 (0.1%) 5/1308 (0.4%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED 1/1296 (0.1%) 1/1308 (0.1%)
ANGIOGRAM 1/1296 (0.1%) 0/1308 (0%)
ARTERIAL BRUIT 0/1296 (0%) 1/1308 (0.1%)
ARTERIOGRAM CORONARY 2/1296 (0.2%) 0/1308 (0%)
ARTERIOGRAM CORONARY ABNORMAL 1/1296 (0.1%) 3/1308 (0.2%)
BLOOD CHOLESTEROL DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD CHOLESTEROL INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD CREATINE PHOSPHOKINASE INCREASED 18/1296 (1.4%) 19/1308 (1.5%)
BLOOD CREATINE PHOSPHOKINASE MB ABNORMAL 1/1296 (0.1%) 0/1308 (0%)
BLOOD CREATINE PHOSPHOKINASE MB DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED 68/1296 (5.2%) 59/1308 (4.5%)
BLOOD CREATININE INCREASED 2/1296 (0.2%) 1/1308 (0.1%)
BLOOD GLUCOSE DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD GLUCOSE INCREASED 4/1296 (0.3%) 4/1308 (0.3%)
BLOOD LACTIC ACID INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD MAGNESIUM DECREASED 1/1296 (0.1%) 0/1308 (0%)
BLOOD POTASSIUM DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD PRESSURE DECREASED 1/1296 (0.1%) 0/1308 (0%)
BLOOD PRESSURE INCREASED 9/1296 (0.7%) 2/1308 (0.2%)
BLOOD PRESSURE SYSTOLIC DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD PRESSURE SYSTOLIC INCREASED 2/1296 (0.2%) 0/1308 (0%)
BLOOD TESTOSTERONE DECREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD TRIGLYCERIDES INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD URIC ACID INCREASED 0/1296 (0%) 1/1308 (0.1%)
BLOOD URINE PRESENT 1/1296 (0.1%) 0/1308 (0%)
CARDIAC ENZYMES INCREASED 149/1296 (11.5%) 149/1308 (11.4%)
CARDIAC MURMUR 0/1296 (0%) 1/1308 (0.1%)
CARDIAC STRESS TEST ABNORMAL 2/1296 (0.2%) 4/1308 (0.3%)
CAROTID BRUIT 0/1296 (0%) 1/1308 (0.1%)
CATHETERISATION CARDIAC 1/1296 (0.1%) 0/1308 (0%)
COMPUTERISED TOMOGRAM THORAX ABNORMAL 1/1296 (0.1%) 0/1308 (0%)
EJECTION FRACTION DECREASED 1/1296 (0.1%) 1/1308 (0.1%)
ELECTROCARDIOGRAM ABNORMAL 2/1296 (0.2%) 1/1308 (0.1%)
ELECTROCARDIOGRAM ST SEGMENT ELEVATION 2/1296 (0.2%) 1/1308 (0.1%)
FEMORAL BRUIT 1/1296 (0.1%) 0/1308 (0%)
FIBRIN D DIMER INCREASED 0/1296 (0%) 1/1308 (0.1%)
GLYCOSYLATED HAEMOGLOBIN INCREASED 0/1296 (0%) 3/1308 (0.2%)
HAEMOGLOBIN DECREASED 1/1296 (0.1%) 1/1308 (0.1%)
HEART RATE DECREASED 0/1296 (0%) 1/1308 (0.1%)
HEART RATE INCREASED 1/1296 (0.1%) 2/1308 (0.2%)
HEART RATE IRREGULAR 0/1296 (0%) 2/1308 (0.2%)
HEPATIC ENZYME INCREASED 2/1296 (0.2%) 3/1308 (0.2%)
INFLUENZA A VIRUS TEST POSITIVE 0/1296 (0%) 1/1308 (0.1%)
LEFT VENTRICULAR END-DIASTOLIC PRESSURE INCREASED 1/1296 (0.1%) 1/1308 (0.1%)
LIVER FUNCTION TEST ABNORMAL 3/1296 (0.2%) 3/1308 (0.2%)
LIVER SCAN ABNORMAL 0/1296 (0%) 1/1308 (0.1%)
LOW DENSITY LIPOPROTEIN INCREASED 1/1296 (0.1%) 0/1308 (0%)
LYMPHOCYTE COUNT INCREASED 1/1296 (0.1%) 0/1308 (0%)
MEAN CELL VOLUME ABNORMAL 0/1296 (0%) 1/1308 (0.1%)
OCCULT BLOOD POSITIVE 1/1296 (0.1%) 0/1308 (0%)
OESOPHAGOGASTRODUODENOSCOPY ABNORMAL 0/1296 (0%) 1/1308 (0.1%)
OXYGEN SATURATION DECREASED 1/1296 (0.1%) 0/1308 (0%)
PLATELET COUNT DECREASED 1/1296 (0.1%) 0/1308 (0%)
PROSTATIC SPECIFIC ANTIGEN INCREASED 1/1296 (0.1%) 3/1308 (0.2%)
STRESS ECHOCARDIOGRAM ABNORMAL 1/1296 (0.1%) 0/1308 (0%)
TRANSAMINASES INCREASED 0/1296 (0%) 1/1308 (0.1%)
TROPONIN I INCREASED 8/1296 (0.6%) 14/1308 (1.1%)
TROPONIN INCREASED 107/1296 (8.3%) 86/1308 (6.6%)
TROPONIN T INCREASED 14/1296 (1.1%) 12/1308 (0.9%)
ULTRASOUND THYROID ABNORMAL 0/1296 (0%) 1/1308 (0.1%)
WEIGHT DECREASED 0/1296 (0%) 2/1308 (0.2%)
WEIGHT INCREASED 2/1296 (0.2%) 2/1308 (0.2%)
WHITE BLOOD CELL COUNT DECREASED 1/1296 (0.1%) 0/1308 (0%)
Metabolism and nutrition disorders
CARBOHYDRATE INTOLERANCE 1/1296 (0.1%) 0/1308 (0%)
DECREASED APPETITE 2/1296 (0.2%) 0/1308 (0%)
DEHYDRATION 3/1296 (0.2%) 4/1308 (0.3%)
DIABETES MELLITUS 5/1296 (0.4%) 6/1308 (0.5%)
DIABETES MELLITUS INADEQUATE CONTROL 1/1296 (0.1%) 0/1308 (0%)
DIABETIC KETOACIDOSIS 1/1296 (0.1%) 6/1308 (0.5%)
FAILURE TO THRIVE 1/1296 (0.1%) 0/1308 (0%)
FLUID OVERLOAD 1/1296 (0.1%) 0/1308 (0%)
GLUCOSE TOLERANCE IMPAIRED 2/1296 (0.2%) 1/1308 (0.1%)
GOUT 9/1296 (0.7%) 2/1308 (0.2%)
HYPERCALCAEMIA 0/1296 (0%) 1/1308 (0.1%)
HYPERCHOLESTEROLAEMIA 1/1296 (0.1%) 0/1308 (0%)
HYPERGLYCAEMIA 4/1296 (0.3%) 3/1308 (0.2%)
HYPERKALAEMIA 3/1296 (0.2%) 0/1308 (0%)
HYPERLIPIDAEMIA 2/1296 (0.2%) 4/1308 (0.3%)
HYPERTRIGLYCERIDAEMIA 1/1296 (0.1%) 1/1308 (0.1%)
HYPERURICAEMIA 1/1296 (0.1%) 0/1308 (0%)
HYPOGLYCAEMIA 4/1296 (0.3%) 4/1308 (0.3%)
HYPOKALAEMIA 0/1296 (0%) 1/1308 (0.1%)
HYPOMAGNESAEMIA 0/1296 (0%) 2/1308 (0.2%)
HYPONATRAEMIA 0/1296 (0%) 3/1308 (0.2%)
HYPOVITAMINOSIS 0/1296 (0%) 1/1308 (0.1%)
HYPOVOLAEMIA 1/1296 (0.1%) 0/1308 (0%)
IRON DEFICIENCY 1/1296 (0.1%) 0/1308 (0%)
KETOACIDOSIS 1/1296 (0.1%) 0/1308 (0%)
LACTIC ACIDOSIS 0/1296 (0%) 1/1308 (0.1%)
MALNUTRITION 0/1296 (0%) 1/1308 (0.1%)
METABOLIC ACIDOSIS 0/1296 (0%) 1/1308 (0.1%)
OBESITY 0/1296 (0%) 1/1308 (0.1%)
TYPE 2 DIABETES MELLITUS 3/1296 (0.2%) 4/1308 (0.3%)
VITAMIN B12 DEFICIENCY 1/1296 (0.1%) 0/1308 (0%)
VITAMIN D DEFICIENCY 2/1296 (0.2%) 2/1308 (0.2%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 28/1296 (2.2%) 21/1308 (1.6%)
ARTHRITIS 7/1296 (0.5%) 5/1308 (0.4%)
ARTHROPATHY 1/1296 (0.1%) 0/1308 (0%)
BACK PAIN 25/1296 (1.9%) 32/1308 (2.4%)
BONE PAIN 0/1296 (0%) 1/1308 (0.1%)
BURSITIS 3/1296 (0.2%) 1/1308 (0.1%)
CERVICAL SPINAL STENOSIS 1/1296 (0.1%) 2/1308 (0.2%)
CHONDROMALACIA 2/1296 (0.2%) 0/1308 (0%)
CHONDROSIS 0/1296 (0%) 1/1308 (0.1%)
COSTOCHONDRITIS 0/1296 (0%) 3/1308 (0.2%)
DUPUYTREN'S CONTRACTURE 0/1296 (0%) 1/1308 (0.1%)
EXOSTOSIS 0/1296 (0%) 1/1308 (0.1%)
FLANK PAIN 2/1296 (0.2%) 1/1308 (0.1%)
FOOT DEFORMITY 2/1296 (0.2%) 1/1308 (0.1%)
GROIN PAIN 1/1296 (0.1%) 0/1308 (0%)
INTERVERTEBRAL DISC COMPRESSION 1/1296 (0.1%) 0/1308 (0%)
INTERVERTEBRAL DISC DEGENERATION 1/1296 (0.1%) 3/1308 (0.2%)
INTERVERTEBRAL DISC PROTRUSION 5/1296 (0.4%) 5/1308 (0.4%)
JOINT EFFUSION 1/1296 (0.1%) 1/1308 (0.1%)
JOINT STIFFNESS 0/1296 (0%) 2/1308 (0.2%)
JOINT SWELLING 6/1296 (0.5%) 4/1308 (0.3%)
LIMB DISCOMFORT 2/1296 (0.2%) 1/1308 (0.1%)
LUMBAR SPINAL STENOSIS 3/1296 (0.2%) 4/1308 (0.3%)
MONARTHRITIS 0/1296 (0%) 1/1308 (0.1%)
MUSCLE ATROPHY 0/1296 (0%) 1/1308 (0.1%)
MUSCLE SPASMS 9/1296 (0.7%) 9/1308 (0.7%)
MUSCLE TIGHTNESS 0/1296 (0%) 2/1308 (0.2%)
MUSCLE TWITCHING 1/1296 (0.1%) 0/1308 (0%)
MUSCULAR WEAKNESS 7/1296 (0.5%) 4/1308 (0.3%)
MUSCULOSKELETAL CHEST PAIN 11/1296 (0.8%) 12/1308 (0.9%)
MUSCULOSKELETAL DISCOMFORT 2/1296 (0.2%) 2/1308 (0.2%)
MUSCULOSKELETAL PAIN 22/1296 (1.7%) 20/1308 (1.5%)
MUSCULOSKELETAL STIFFNESS 0/1296 (0%) 2/1308 (0.2%)
MYALGIA 22/1296 (1.7%) 17/1308 (1.3%)
NECK PAIN 6/1296 (0.5%) 6/1308 (0.5%)
NEUROPATHIC ARTHROPATHY 0/1296 (0%) 1/1308 (0.1%)
OSTEOARTHRITIS 17/1296 (1.3%) 16/1308 (1.2%)
OSTEOCHONDROSIS 0/1296 (0%) 1/1308 (0.1%)
OSTEOSCLEROSIS 1/1296 (0.1%) 0/1308 (0%)
PAIN IN EXTREMITY 18/1296 (1.4%) 32/1308 (2.4%)
PAIN IN JAW 3/1296 (0.2%) 0/1308 (0%)
PLANTAR FASCIAL FIBROMATOSIS 1/1296 (0.1%) 0/1308 (0%)
PLANTAR FASCIITIS 0/1296 (0%) 1/1308 (0.1%)
PSORIATIC ARTHROPATHY 1/1296 (0.1%) 0/1308 (0%)
RHABDOMYOLYSIS 2/1296 (0.2%) 0/1308 (0%)
RHEUMATOID ARTHRITIS 0/1296 (0%) 3/1308 (0.2%)
ROTATOR CUFF SYNDROME 6/1296 (0.5%) 7/1308 (0.5%)
SCLERODERMA 1/1296 (0.1%) 0/1308 (0%)
SPINAL COLUMN STENOSIS 0/1296 (0%) 2/1308 (0.2%)
SPINAL DISORDER 1/1296 (0.1%) 1/1308 (0.1%)
SPINAL OSTEOARTHRITIS 3/1296 (0.2%) 2/1308 (0.2%)
SYNOVIAL CYST 3/1296 (0.2%) 1/1308 (0.1%)
TENDONITIS 1/1296 (0.1%) 1/1308 (0.1%)
TRIGGER FINGER 2/1296 (0.2%) 2/1308 (0.2%)
VERTEBRAL FORAMINAL STENOSIS 0/1296 (0%) 1/1308 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE PROMYELOCYTIC LEUKAEMIA 1/1296 (0.1%) 0/1308 (0%)
ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
B-CELL LYMPHOMA 1/1296 (0.1%) 0/1308 (0%)
B-CELL LYMPHOMA STAGE I 0/1296 (0%) 1/1308 (0.1%)
B-CELL LYMPHOMA STAGE IV 0/1296 (0%) 1/1308 (0.1%)
BASAL CELL CARCINOMA 6/1296 (0.5%) 5/1308 (0.4%)
BENIGN BREAST NEOPLASM 1/1296 (0.1%) 0/1308 (0%)
BENIGN SOFT TISSUE NEOPLASM 1/1296 (0.1%) 0/1308 (0%)
BILE DUCT CANCER 1/1296 (0.1%) 0/1308 (0%)
BLADDER CANCER 1/1296 (0.1%) 0/1308 (0%)
BOWEN'S DISEASE 0/1296 (0%) 1/1308 (0.1%)
BREAST CANCER 1/1296 (0.1%) 1/1308 (0.1%)
BREAST CANCER IN SITU 1/1296 (0.1%) 0/1308 (0%)
BREAST CANCER STAGE II 1/1296 (0.1%) 0/1308 (0%)
COLON ADENOMA 3/1296 (0.2%) 0/1308 (0%)
COLON CANCER 3/1296 (0.2%) 1/1308 (0.1%)
ENDOMETRIAL CANCER 1/1296 (0.1%) 1/1308 (0.1%)
ENDOMETRIAL CANCER METASTATIC 0/1296 (0%) 1/1308 (0.1%)
FIBROMA 1/1296 (0.1%) 0/1308 (0%)
GASTROINTESTINAL STROMAL TUMOUR 0/1296 (0%) 1/1308 (0.1%)
HEPATIC NEOPLASM MALIGNANT RECURRENT 0/1296 (0%) 1/1308 (0.1%)
INTESTINAL ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
LIPOMA 1/1296 (0.1%) 1/1308 (0.1%)
LUNG ADENOCARCINOMA 1/1296 (0.1%) 0/1308 (0%)
LUNG CANCER METASTATIC 1/1296 (0.1%) 0/1308 (0%)
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV 0/1296 (0%) 1/1308 (0.1%)
LUNG NEOPLASM 2/1296 (0.2%) 2/1308 (0.2%)
LUNG NEOPLASM MALIGNANT 4/1296 (0.3%) 0/1308 (0%)
LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
MALIGNANT GLIOMA 0/1296 (0%) 1/1308 (0.1%)
MALIGNANT MELANOMA 1/1296 (0.1%) 1/1308 (0.1%)
MALIGNANT PLEURAL EFFUSION 0/1296 (0%) 1/1308 (0.1%)
MANTLE CELL LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
MENINGIOMA 0/1296 (0%) 1/1308 (0.1%)
METASTASES TO CENTRAL NERVOUS SYSTEM 1/1296 (0.1%) 0/1308 (0%)
METASTATIC RENAL CELL CARCINOMA 1/1296 (0.1%) 0/1308 (0%)
MUELLER'S MIXED TUMOUR 1/1296 (0.1%) 0/1308 (0%)
MULTIPLE MYELOMA 0/1296 (0%) 1/1308 (0.1%)
MYELODYSPLASTIC SYNDROME 2/1296 (0.2%) 0/1308 (0%)
NEOPLASM MALIGNANT 2/1296 (0.2%) 1/1308 (0.1%)
NEOPLASM SKIN 0/1296 (0%) 1/1308 (0.1%)
NEUROENDOCRINE CARCINOMA METASTATIC 1/1296 (0.1%) 0/1308 (0%)
NON-HODGKIN'S LYMPHOMA 0/1296 (0%) 1/1308 (0.1%)
OESOPHAGEAL CARCINOMA 0/1296 (0%) 2/1308 (0.2%)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED 0/1296 (0%) 1/1308 (0.1%)
OVARIAN CANCER METASTATIC 1/1296 (0.1%) 1/1308 (0.1%)
OVARIAN CANCER STAGE III 1/1296 (0.1%) 0/1308 (0%)
PANCREATIC CARCINOMA METASTATIC 0/1296 (0%) 2/1308 (0.2%)
PANCREATIC NEUROENDOCRINE TUMOUR 0/1296 (0%) 1/1308 (0.1%)
PARATHYROID TUMOUR BENIGN 0/1296 (0%) 1/1308 (0.1%)
PHAEOCHROMOCYTOMA 1/1296 (0.1%) 0/1308 (0%)
PITUITARY TUMOUR BENIGN 0/1296 (0%) 1/1308 (0.1%)
PLASMACYTOMA 1/1296 (0.1%) 0/1308 (0%)
PROSTATE CANCER 4/1296 (0.3%) 5/1308 (0.4%)
RENAL CELL CARCINOMA 0/1296 (0%) 1/1308 (0.1%)
SALIVARY GLAND CANCER 0/1296 (0%) 1/1308 (0.1%)
SALIVARY GLAND NEOPLASM 1/1296 (0.1%) 1/1308 (0.1%)
SEBORRHOEIC KERATOSIS 0/1296 (0%) 1/1308 (0.1%)
SKIN CANCER 0/1296 (0%) 1/1308 (0.1%)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1/1296 (0.1%) 0/1308 (0%)
SQUAMOUS CELL CARCINOMA 0/1296 (0%) 1/1308 (0.1%)
SQUAMOUS CELL CARCINOMA OF SKIN 0/1296 (0%) 1/1308 (0.1%)
THYROID NEOPLASM 0/1296 (0%) 2/1308 (0.2%)
TRANSITIONAL CELL CARCINOMA 1/1296 (0.1%) 0/1308 (0%)
URETERIC CANCER RECURRENT 1/1296 (0.1%) 0/1308 (0%)
Nervous system disorders
APHASIA 1/1296 (0.1%) 2/1308 (0.2%)
BASAL GANGLIA INFARCTION 0/1296 (0%) 1/1308 (0.1%)
BASILAR ARTERY STENOSIS 0/1296 (0%) 1/1308 (0.1%)
BRAIN INJURY 0/1296 (0%) 1/1308 (0.1%)
BRAIN MASS 0/1296 (0%) 2/1308 (0.2%)
CAROTID ARTERIOSCLEROSIS 1/1296 (0.1%) 1/1308 (0.1%)
CAROTID ARTERY STENOSIS 4/1296 (0.3%) 5/1308 (0.4%)
CARPAL TUNNEL SYNDROME 7/1296 (0.5%) 7/1308 (0.5%)
CENTRAL NERVOUS SYSTEM LESION 1/1296 (0.1%) 0/1308 (0%)
CEREBELLAR ATROPHY 1/1296 (0.1%) 0/1308 (0%)
CEREBELLAR INFARCTION 0/1296 (0%) 2/1308 (0.2%)
CEREBRAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
CEREBROVASCULAR ACCIDENT 5/1296 (0.4%) 16/1308 (1.2%)
CERVICAL MYELOPATHY 1/1296 (0.1%) 0/1308 (0%)
CERVICOBRACHIAL SYNDROME 3/1296 (0.2%) 1/1308 (0.1%)
COGNITIVE DISORDER 0/1296 (0%) 1/1308 (0.1%)
COMPLICATED MIGRAINE 1/1296 (0.1%) 1/1308 (0.1%)
CONVULSION 1/1296 (0.1%) 2/1308 (0.2%)
CUBITAL TUNNEL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
DEMENTIA 1/1296 (0.1%) 1/1308 (0.1%)
DEPRESSED LEVEL OF CONSCIOUSNESS 1/1296 (0.1%) 0/1308 (0%)
DIABETIC NEUROPATHY 1/1296 (0.1%) 1/1308 (0.1%)
DIZZINESS 61/1296 (4.7%) 60/1308 (4.6%)
DIZZINESS EXERTIONAL 1/1296 (0.1%) 0/1308 (0%)
DIZZINESS POSTURAL 14/1296 (1.1%) 6/1308 (0.5%)
DRUG WITHDRAWAL HEADACHE 1/1296 (0.1%) 0/1308 (0%)
DYSARTHRIA 0/1296 (0%) 3/1308 (0.2%)
DYSGEUSIA 1/1296 (0.1%) 0/1308 (0%)
EMBOLIC CEREBRAL INFARCTION 1/1296 (0.1%) 0/1308 (0%)
ENCEPHALOPATHY 4/1296 (0.3%) 2/1308 (0.2%)
EPILEPSY 0/1296 (0%) 1/1308 (0.1%)
FACIAL PARESIS 0/1296 (0%) 1/1308 (0.1%)
GRAND MAL CONVULSION 2/1296 (0.2%) 1/1308 (0.1%)
HAEMORRHAGE INTRACRANIAL 1/1296 (0.1%) 1/1308 (0.1%)
HEAD DISCOMFORT 1/1296 (0.1%) 0/1308 (0%)
HEAD TITUBATION 0/1296 (0%) 1/1308 (0.1%)
HEADACHE 19/1296 (1.5%) 22/1308 (1.7%)
HYPERTONIA 0/1296 (0%) 1/1308 (0.1%)
HYPOAESTHESIA 21/1296 (1.6%) 13/1308 (1%)
INTERCOSTAL NEURALGIA 1/1296 (0.1%) 0/1308 (0%)
ISCHAEMIC STROKE 0/1296 (0%) 4/1308 (0.3%)
LACUNAR INFARCTION 2/1296 (0.2%) 0/1308 (0%)
LETHARGY 0/1296 (0%) 2/1308 (0.2%)
LOSS OF CONSCIOUSNESS 1/1296 (0.1%) 0/1308 (0%)
LUMBAR RADICULOPATHY 0/1296 (0%) 1/1308 (0.1%)
MEMORY IMPAIRMENT 0/1296 (0%) 1/1308 (0.1%)
METABOLIC ENCEPHALOPATHY 2/1296 (0.2%) 0/1308 (0%)
MIGRAINE 5/1296 (0.4%) 3/1308 (0.2%)
MULTIPLE SCLEROSIS 0/1296 (0%) 1/1308 (0.1%)
NERVE COMPRESSION 2/1296 (0.2%) 2/1308 (0.2%)
NEURALGIA 2/1296 (0.2%) 1/1308 (0.1%)
NEUROPATHY PERIPHERAL 3/1296 (0.2%) 5/1308 (0.4%)
PARAESTHESIA 26/1296 (2%) 25/1308 (1.9%)
PARTIAL SEIZURES 0/1296 (0%) 1/1308 (0.1%)
PRESYNCOPE 10/1296 (0.8%) 7/1308 (0.5%)
RADIAL NERVE COMPRESSION 0/1296 (0%) 1/1308 (0.1%)
RADICULOPATHY 2/1296 (0.2%) 0/1308 (0%)
RESTLESS LEGS SYNDROME 2/1296 (0.2%) 0/1308 (0%)
SCIATICA 5/1296 (0.4%) 4/1308 (0.3%)
SENSORY LOSS 0/1296 (0%) 1/1308 (0.1%)
SOMNOLENCE 2/1296 (0.2%) 2/1308 (0.2%)
SUBARACHNOID HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
SYNCOPE 14/1296 (1.1%) 20/1308 (1.5%)
TRANSIENT ISCHAEMIC ATTACK 6/1296 (0.5%) 5/1308 (0.4%)
TREMOR 1/1296 (0.1%) 0/1308 (0%)
TYPICAL AURA WITHOUT HEADACHE 1/1296 (0.1%) 0/1308 (0%)
ULNAR TUNNEL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
VIITH NERVE PARALYSIS 2/1296 (0.2%) 0/1308 (0%)
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS 0/1296 (0%) 1/1308 (0.1%)
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME 1/1296 (0.1%) 0/1308 (0%)
ANORGASMIA 0/1296 (0%) 1/1308 (0.1%)
ANXIETY 18/1296 (1.4%) 15/1308 (1.1%)
ANXIETY DISORDER DUE TO A GENERAL MEDICAL CONDITION 1/1296 (0.1%) 0/1308 (0%)
COMPLETED SUICIDE 1/1296 (0.1%) 0/1308 (0%)
CONFUSIONAL STATE 1/1296 (0.1%) 1/1308 (0.1%)
CONVERSION DISORDER 1/1296 (0.1%) 0/1308 (0%)
DELIRIUM 2/1296 (0.2%) 0/1308 (0%)
DEPRESSION 5/1296 (0.4%) 9/1308 (0.7%)
DEPRESSION SUICIDAL 0/1296 (0%) 2/1308 (0.2%)
DISORIENTATION 1/1296 (0.1%) 0/1308 (0%)
INSOMNIA 6/1296 (0.5%) 7/1308 (0.5%)
INTENTIONAL SELF-INJURY 0/1296 (0%) 2/1308 (0.2%)
MENTAL STATUS CHANGES 4/1296 (0.3%) 4/1308 (0.3%)
PANIC ATTACK 2/1296 (0.2%) 4/1308 (0.3%)
PANIC DISORDER 1/1296 (0.1%) 0/1308 (0%)
PERSONALITY DISORDER 1/1296 (0.1%) 0/1308 (0%)
POST-TRAUMATIC AMNESTIC DISORDER 0/1296 (0%) 1/1308 (0.1%)
SLEEP DISORDER 0/1296 (0%) 1/1308 (0.1%)
SOMATOFORM DISORDER 0/1296 (0%) 1/1308 (0.1%)
STRESS 1/1296 (0.1%) 1/1308 (0.1%)
SUICIDAL IDEATION 1/1296 (0.1%) 0/1308 (0%)
SUICIDE ATTEMPT 0/1296 (0%) 1/1308 (0.1%)
WITHDRAWAL SYNDROME 0/1296 (0%) 1/1308 (0.1%)
Renal and urinary disorders
AZOTAEMIA 0/1296 (0%) 1/1308 (0.1%)
BLADDER NECK OBSTRUCTION 0/1296 (0%) 1/1308 (0.1%)
BLADDER PROLAPSE 1/1296 (0.1%) 0/1308 (0%)
CALCULUS URETERIC 1/1296 (0.1%) 1/1308 (0.1%)
CALCULUS URINARY 0/1296 (0%) 1/1308 (0.1%)
CYSTITIS HAEMORRHAGIC 1/1296 (0.1%) 0/1308 (0%)
DYSURIA 5/1296 (0.4%) 1/1308 (0.1%)
HAEMATURIA 7/1296 (0.5%) 14/1308 (1.1%)
HYDRONEPHROSIS 1/1296 (0.1%) 0/1308 (0%)
HYPERTONIC BLADDER 0/1296 (0%) 1/1308 (0.1%)
NEPHROLITHIASIS 9/1296 (0.7%) 8/1308 (0.6%)
NOCTURIA 2/1296 (0.2%) 0/1308 (0%)
OBSTRUCTIVE UROPATHY 0/1296 (0%) 1/1308 (0.1%)
POLLAKIURIA 2/1296 (0.2%) 0/1308 (0%)
POLYURIA 1/1296 (0.1%) 0/1308 (0%)
RENAL ARTERY STENOSIS 1/1296 (0.1%) 2/1308 (0.2%)
RENAL COLIC 1/1296 (0.1%) 0/1308 (0%)
RENAL CYST 3/1296 (0.2%) 2/1308 (0.2%)
RENAL FAILURE 2/1296 (0.2%) 1/1308 (0.1%)
RENAL FAILURE ACUTE 14/1296 (1.1%) 15/1308 (1.1%)
RENAL FAILURE CHRONIC 0/1296 (0%) 2/1308 (0.2%)
RENAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
RENAL IMPAIRMENT 1/1296 (0.1%) 3/1308 (0.2%)
RENAL MASS 2/1296 (0.2%) 0/1308 (0%)
RENAL PAIN 1/1296 (0.1%) 0/1308 (0%)
URETHRAL MEATUS STENOSIS 0/1296 (0%) 1/1308 (0.1%)
URINARY BLADDER POLYP 0/1296 (0%) 1/1308 (0.1%)
URINARY FISTULA 1/1296 (0.1%) 0/1308 (0%)
URINARY HESITATION 0/1296 (0%) 1/1308 (0.1%)
URINARY INCONTINENCE 1/1296 (0.1%) 3/1308 (0.2%)
URINARY RETENTION 3/1296 (0.2%) 2/1308 (0.2%)
URINARY TRACT OBSTRUCTION 1/1296 (0.1%) 0/1308 (0%)
URINE FLOW DECREASED 1/1296 (0.1%) 0/1308 (0%)
Reproductive system and breast disorders
ATROPHIC VULVOVAGINITIS 0/1296 (0%) 1/1308 (0.1%)
BENIGN PROSTATIC HYPERPLASIA 7/1296 (0.5%) 4/1308 (0.3%)
BREAST PAIN 2/1296 (0.2%) 0/1308 (0%)
CYSTOCELE 0/1296 (0%) 1/1308 (0.1%)
EPIDIDYMITIS 1/1296 (0.1%) 2/1308 (0.2%)
ERECTILE DYSFUNCTION 4/1296 (0.3%) 1/1308 (0.1%)
GENITAL SWELLING 0/1296 (0%) 1/1308 (0.1%)
MENORRHAGIA 0/1296 (0%) 1/1308 (0.1%)
PENILE PAIN 0/1296 (0%) 2/1308 (0.2%)
PROSTATITIS 0/1296 (0%) 1/1308 (0.1%)
PROSTATOMEGALY 1/1296 (0.1%) 1/1308 (0.1%)
SCROTAL CYST 0/1296 (0%) 1/1308 (0.1%)
UTERINE POLYP 1/1296 (0.1%) 0/1308 (0%)
VAGINAL HAEMATOMA 1/1296 (0.1%) 0/1308 (0%)
VAGINAL HAEMORRHAGE 0/1296 (0%) 4/1308 (0.3%)
VAGINAL PROLAPSE 1/1296 (0.1%) 1/1308 (0.1%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA 1/1296 (0.1%) 0/1308 (0%)
ACUTE RESPIRATORY FAILURE 6/1296 (0.5%) 5/1308 (0.4%)
ASTHMA 7/1296 (0.5%) 2/1308 (0.2%)
ATELECTASIS 3/1296 (0.2%) 3/1308 (0.2%)
BRONCHITIS CHRONIC 0/1296 (0%) 1/1308 (0.1%)
BRONCHOSPASM 0/1296 (0%) 1/1308 (0.1%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 14/1296 (1.1%) 14/1308 (1.1%)
COUGH 17/1296 (1.3%) 30/1308 (2.3%)
DIAPHRAGMATIC PARALYSIS 1/1296 (0.1%) 0/1308 (0%)
DYSPNOEA 137/1296 (10.6%) 135/1308 (10.3%)
DYSPNOEA AT REST 1/1296 (0.1%) 0/1308 (0%)
DYSPNOEA EXERTIONAL 49/1296 (3.8%) 57/1308 (4.4%)
EMPHYSEMA 3/1296 (0.2%) 0/1308 (0%)
EPISTAXIS 20/1296 (1.5%) 12/1308 (0.9%)
HAEMOPTYSIS 2/1296 (0.2%) 2/1308 (0.2%)
HYPOXIA 2/1296 (0.2%) 0/1308 (0%)
INTERSTITIAL LUNG DISEASE 1/1296 (0.1%) 0/1308 (0%)
LUNG DISORDER 1/1296 (0.1%) 0/1308 (0%)
NASAL CONGESTION 1/1296 (0.1%) 1/1308 (0.1%)
NASAL SEPTUM DEVIATION 1/1296 (0.1%) 0/1308 (0%)
OBSTRUCTIVE AIRWAYS DISORDER 1/1296 (0.1%) 1/1308 (0.1%)
OROPHARYNGEAL DISCOMFORT 0/1296 (0%) 1/1308 (0.1%)
OROPHARYNGEAL PAIN 1/1296 (0.1%) 1/1308 (0.1%)
PHARYNGEAL HYPERTROPHY 0/1296 (0%) 1/1308 (0.1%)
PLEURAL EFFUSION 4/1296 (0.3%) 2/1308 (0.2%)
PLEURITIC PAIN 2/1296 (0.2%) 4/1308 (0.3%)
PNEUMONIA ASPIRATION 2/1296 (0.2%) 1/1308 (0.1%)
PNEUMOTHORAX 2/1296 (0.2%) 0/1308 (0%)
PRODUCTIVE COUGH 1/1296 (0.1%) 2/1308 (0.2%)
PULMONARY CONGESTION 0/1296 (0%) 3/1308 (0.2%)
PULMONARY EMBOLISM 5/1296 (0.4%) 3/1308 (0.2%)
PULMONARY FIBROSIS 1/1296 (0.1%) 1/1308 (0.1%)
PULMONARY HYPERTENSION 2/1296 (0.2%) 2/1308 (0.2%)
PULMONARY MASS 0/1296 (0%) 1/1308 (0.1%)
PULMONARY OEDEMA 1/1296 (0.1%) 1/1308 (0.1%)
REFLUX LARYNGITIS 1/1296 (0.1%) 0/1308 (0%)
RESPIRATORY DISTRESS 2/1296 (0.2%) 0/1308 (0%)
RESPIRATORY FAILURE 6/1296 (0.5%) 2/1308 (0.2%)
RESTRICTIVE PULMONARY DISEASE 0/1296 (0%) 1/1308 (0.1%)
RHINITIS ALLERGIC 2/1296 (0.2%) 1/1308 (0.1%)
SINUS CONGESTION 1/1296 (0.1%) 0/1308 (0%)
SLEEP APNOEA SYNDROME 6/1296 (0.5%) 12/1308 (0.9%)
THROAT IRRITATION 2/1296 (0.2%) 0/1308 (0%)
THROAT TIGHTNESS 1/1296 (0.1%) 0/1308 (0%)
UPPER RESPIRATORY TRACT CONGESTION 1/1296 (0.1%) 0/1308 (0%)
VOCAL CORD POLYP 0/1296 (0%) 1/1308 (0.1%)
WHEEZING 0/1296 (0%) 2/1308 (0.2%)
Skin and subcutaneous tissue disorders
ACNE 0/1296 (0%) 1/1308 (0.1%)
ACTINIC KERATOSIS 2/1296 (0.2%) 1/1308 (0.1%)
ALOPECIA 1/1296 (0.1%) 0/1308 (0%)
ANGIOEDEMA 0/1296 (0%) 1/1308 (0.1%)
DERMAL CYST 0/1296 (0%) 1/1308 (0.1%)
DERMATITIS 1/1296 (0.1%) 2/1308 (0.2%)
DERMATITIS CONTACT 1/1296 (0.1%) 1/1308 (0.1%)
DRUG ERUPTION 10/1296 (0.8%) 5/1308 (0.4%)
DRY GANGRENE 0/1296 (0%) 1/1308 (0.1%)
ECCHYMOSIS 1/1296 (0.1%) 4/1308 (0.3%)
ERYTHEMA 1/1296 (0.1%) 1/1308 (0.1%)
HYPERHIDROSIS 20/1296 (1.5%) 19/1308 (1.5%)
INCREASED TENDENCY TO BRUISE 4/1296 (0.3%) 6/1308 (0.5%)
INGROWING NAIL 1/1296 (0.1%) 0/1308 (0%)
LICHEN SCLEROSUS 0/1296 (0%) 1/1308 (0.1%)
LIVEDO RETICULARIS 0/1296 (0%) 1/1308 (0.1%)
NIGHT SWEATS 3/1296 (0.2%) 4/1308 (0.3%)
PETECHIAE 1/1296 (0.1%) 0/1308 (0%)
PRECANCEROUS SKIN LESION 1/1296 (0.1%) 0/1308 (0%)
PRURITUS 4/1296 (0.3%) 2/1308 (0.2%)
PRURITUS ALLERGIC 0/1296 (0%) 2/1308 (0.2%)
PSORIASIS 0/1296 (0%) 1/1308 (0.1%)
RASH 12/1296 (0.9%) 5/1308 (0.4%)
RASH GENERALISED 0/1296 (0%) 1/1308 (0.1%)
RASH MACULAR 1/1296 (0.1%) 0/1308 (0%)
RASH PRURITIC 4/1296 (0.3%) 2/1308 (0.2%)
SCAR PAIN 0/1296 (0%) 1/1308 (0.1%)
SKIN DISCOLOURATION 0/1296 (0%) 1/1308 (0.1%)
SKIN FISSURES 0/1296 (0%) 1/1308 (0.1%)
SKIN LESION 2/1296 (0.2%) 3/1308 (0.2%)
SKIN ULCER 2/1296 (0.2%) 0/1308 (0%)
SWELLING FACE 0/1296 (0%) 1/1308 (0.1%)
SYSTEMIC LUPUS ERYTHEMATOSUS RASH 1/1296 (0.1%) 0/1308 (0%)
URTICARIA 5/1296 (0.4%) 2/1308 (0.2%)
Social circumstances
MENOPAUSE 1/1296 (0.1%) 0/1308 (0%)
PHYSICAL ASSAULT 0/1296 (0%) 1/1308 (0.1%)
TREATMENT NONCOMPLIANCE 0/1296 (0%) 1/1308 (0.1%)
Surgical and medical procedures
ABSCESS DRAINAGE 0/1296 (0%) 1/1308 (0.1%)
BAKER'S CYST EXCISION 1/1296 (0.1%) 0/1308 (0%)
CARDIAC PACEMAKER BATTERY REPLACEMENT 0/1296 (0%) 1/1308 (0.1%)
CATARACT OPERATION 2/1296 (0.2%) 0/1308 (0%)
FRACTURE REDUCTION 0/1296 (0%) 1/1308 (0.1%)
HIP ARTHROPLASTY 0/1296 (0%) 1/1308 (0.1%)
HYSTERECTOMY 1/1296 (0.1%) 0/1308 (0%)
MOLE EXCISION 0/1296 (0%) 1/1308 (0.1%)
PERCUTANEOUS CORONARY INTERVENTION 1/1296 (0.1%) 0/1308 (0%)
ROTATOR CUFF REPAIR 1/1296 (0.1%) 0/1308 (0%)
SPINAL FUSION SURGERY 0/1296 (0%) 1/1308 (0.1%)
SURGERY 0/1296 (0%) 1/1308 (0.1%)
Vascular disorders
ACCELERATED HYPERTENSION 0/1296 (0%) 1/1308 (0.1%)
ANEURYSM 1/1296 (0.1%) 1/1308 (0.1%)
AORTIC ANEURYSM 1/1296 (0.1%) 2/1308 (0.2%)
AORTIC DISSECTION 0/1296 (0%) 1/1308 (0.1%)
AORTIC INTRAMURAL HAEMATOMA 1/1296 (0.1%) 1/1308 (0.1%)
AORTIC STENOSIS 2/1296 (0.2%) 2/1308 (0.2%)
ARTERIAL DISORDER 1/1296 (0.1%) 0/1308 (0%)
ARTERIAL HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
ARTERIAL OCCLUSIVE DISEASE 1/1296 (0.1%) 1/1308 (0.1%)
ARTERIAL SPASM 1/1296 (0.1%) 2/1308 (0.2%)
ARTERIAL THROMBOSIS LIMB 0/1296 (0%) 1/1308 (0.1%)
ARTERIOSCLEROSIS 1/1296 (0.1%) 1/1308 (0.1%)
ARTERIOVENOUS FISTULA 1/1296 (0.1%) 1/1308 (0.1%)
DEEP VEIN THROMBOSIS 3/1296 (0.2%) 5/1308 (0.4%)
EMBOLISM ARTERIAL 1/1296 (0.1%) 0/1308 (0%)
FEMORAL ARTERIAL STENOSIS 1/1296 (0.1%) 1/1308 (0.1%)
FEMORAL ARTERY ANEURYSM 1/1296 (0.1%) 0/1308 (0%)
FEMORAL ARTERY DISSECTION 1/1296 (0.1%) 0/1308 (0%)
FEMORAL ARTERY OCCLUSION 1/1296 (0.1%) 1/1308 (0.1%)
HAEMATOMA 8/1296 (0.6%) 8/1308 (0.6%)
HAEMORRHAGE 0/1296 (0%) 1/1308 (0.1%)
HOT FLUSH 2/1296 (0.2%) 1/1308 (0.1%)
HYPERTENSION 42/1296 (3.2%) 51/1308 (3.9%)
HYPERTENSIVE CRISIS 11/1296 (0.8%) 8/1308 (0.6%)
HYPERTENSIVE EMERGENCY 2/1296 (0.2%) 2/1308 (0.2%)
HYPOTENSION 28/1296 (2.2%) 23/1308 (1.8%)
ILIAC ARTERY OCCLUSION 0/1296 (0%) 1/1308 (0.1%)
INTERMITTENT CLAUDICATION 5/1296 (0.4%) 5/1308 (0.4%)
INTRA-ABDOMINAL HAEMATOMA 0/1296 (0%) 1/1308 (0.1%)
ISCHAEMIC LIMB PAIN 0/1296 (0%) 1/1308 (0.1%)
MACROANGIOPATHY 0/1296 (0%) 1/1308 (0.1%)
MALIGNANT HYPERTENSION 1/1296 (0.1%) 0/1308 (0%)
ORTHOSTATIC HYPOTENSION 6/1296 (0.5%) 6/1308 (0.5%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 4/1296 (0.3%) 13/1308 (1%)
PERIPHERAL COLDNESS 0/1296 (0%) 1/1308 (0.1%)
PERIPHERAL VASCULAR DISORDER 1/1296 (0.1%) 2/1308 (0.2%)
REPERFUSION INJURY 2/1296 (0.2%) 2/1308 (0.2%)
THROMBOPHLEBITIS 0/1296 (0%) 1/1308 (0.1%)
THROMBOPHLEBITIS SUPERFICIAL 0/1296 (0%) 2/1308 (0.2%)
THROMBOSIS 1/1296 (0.1%) 0/1308 (0%)
VARICOSE VEIN 1/1296 (0.1%) 0/1308 (0%)
VASOSPASM 1/1296 (0.1%) 1/1308 (0.1%)
VENOUS INSUFFICIENCY 2/1296 (0.2%) 2/1308 (0.2%)
VENOUS THROMBOSIS 0/1296 (0%) 1/1308 (0.1%)
VENOUS THROMBOSIS LIMB 1/1296 (0.1%) 0/1308 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Siok Hwee Tan
Organization Abbott Vascular
Phone 408-571-9281
Email siokwee.tan@abbott.com
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02173379
Other Study ID Numbers:
  • 10-392 C
First Posted:
Jun 25, 2014
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022