A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01923740
• Collaborator: (none)
• Enrollment: 480
• Location: 1
• Arms: 2
• Duration (Months): 68.2
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Artery Stenosis; Coronary Disease; Coronary Stenosis	Device: XIENCE V EECSS; Device: Absorb BVS System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Clinical Evaluation of Absorb™ BVS, the Bioresorbable Vascular Scaffold, in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Chinese Population
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Mar 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System	Device: Absorb BVS System; Subjects receiving Absorb BVS System
Active Comparator: XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V	Device: XIENCE V EECSS; Subjects receiving XIENCE V

Outcome Measures

Primary Outcome Measures

1. In-segment Late Loss (LL) - Per Subject Analysis [1 year]

   In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

2. In-segment Late Loss (LL) - Per Lesion Analysis [1 year]

   In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

Secondary Outcome Measures

1. Acute Device Success [< or = 1 day]

   Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

2. Number of Participants With Acute Procedural Success [At time of procedure up to 7 days in hospital]

   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 assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

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

   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.

4. Number of Death (Cardiac, Vascular, Non-cardiovascular) [0 to 37days]

   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.

5. Number of Death (Cardiac, Vascular, Non-cardiovascular) [0 to 208 days]

   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.

6. Number of Death (Cardiac, Vascular, Non-cardiovascular) [0 to 298 days]

   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.

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

   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.

8. Number of Death (Cardiac, Vascular, Non-cardiovascular) [2 year]

   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.

9. Number of Death (Cardiac, Vascular, Non-cardiovascular) [3 years]

   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.

10. Number of Death (Cardiac, Vascular, Non-cardiovascular) [4 years]

    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.

11. 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. 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

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

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

13. Number of Participants With Myocardial Infarction [0 to 37 days]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

14. Number of Participants With Myocardial Infarction [0 to 208 days]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

15. Number of Participants With Myocardial Infarction [0 to 298 days]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

16. Number of Participants With Myocardial Infarction [1 year]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

17. Number of Participants With Myocardial Infarction [2 year]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

18. Number of Participants With Myocardial Infarction [3 years]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

19. Number of Participants With Myocardial Infarction [4 years]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

20. Number of Participants With Myocardial Infarction [5 years]

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

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

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

22. Number of Participants With Target Lesion Revascularization (TLR) [0 to 37 days]

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

23. Number of Participants With Target Lesion Revascularization (TLR) [0 to 208 days]

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

24. Number of Participants With Target Lesion Revascularization (TLR) [0 to 298 days]

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

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

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

26. Number of Participants With Target Lesion Revascularization (TLR) [2 year]

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

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

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

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

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

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

    Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)

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

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

31. Number of Participants With Target Vessel Revascularization (TVR) [0 to 37 days]

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

32. Number of Participants With Target Vessel Revascularization (TVR) [0 to 208 days]

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

33. Number of Participants With Target Vessel Revascularization (TVR) [0 to 298 days]

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

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

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

35. Number of Participants With Target Vessel Revascularization (TVR) [2 year]

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

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

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

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

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

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

    Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)

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

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

40. Number of Participants With All Coronary Revascularization (PCI and CABG) [0 to 37days]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

41. Number of Participants With All Coronary Revascularization (PCI and CABG) [0 to 208 days]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

42. Number of Participants With All Coronary Revascularization (PCI and CABG) [0 to 298 Days]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

43. Number of Participants With All Coronary Revascularization (PCI and CABG) [1 year]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

44. Number of Participants With All Coronary Revascularization (PCI and CABG) [2 year]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

45. Number of Participants With All Coronary Revascularization (PCI and CABG) [3 years]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

46. Number of Participants With All Coronary Revascularization (PCI and CABG) [4 years]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

47. Number of Participants With All Coronary Revascularization (PCI and CABG) [5 years]

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

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

    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

49. Number of Death/All MI [0 to 37 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

50. Number of Death/All MI [0 to 208 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

51. Number of Death/All MI [0 to 298 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

52. Number of 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

53. Number of Death/All MI [2 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

54. Number of 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

55. Number of 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

56. Number of 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

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

    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.

58. Number of Cardiac Death/All MI [0 to 37 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.

59. Number of Cardiac Death/All MI [0 to 208 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.

60. Number of Cardiac Death/All MI [0 to 298 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.

61. Number of 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.

62. Number of Cardiac Death/All MI [2 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.

63. Number of 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.

64. Number of 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.

65. Number of 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

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

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

67. Number of Participants With All Death/All MI/All Revascularization (DMR) [0 to 37 days]

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

68. Number of Participants With All Death/All MI/All Revascularization (DMR) [0 to 208 days]

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

69. Number of Participants With All Death/All MI/All Revascularization (DMR) [0 to 298 days]

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

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

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

71. Number of Participants With All Death/All MI/All Revascularization (DMR) [2 year]

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

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

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

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

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

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

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

75. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [≤ 7 days post index procedure (In-hospital )]

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

76. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [0 to 37 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))

77. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [0 to 208 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))

78. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [0 to 298 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))

79. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [1 year]

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

80. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [2 year]

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

81. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [3 years]

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

82. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [4 years]

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

83. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] [5 years]

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

84. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [≤ 7 days post index procedure (In-hospital)]

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

85. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [0 to 37 days]

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

86. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [0 to 208 days]

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

87. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [0 to 298 days]

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

88. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [1 year]

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

89. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [2 year]

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

90. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [3 years]

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

91. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [4 years]

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

92. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] [5 years]

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

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

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

94. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) [0 to 37 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).

95. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) [0 to 208 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).

96. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) [0 to 298 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).

97. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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).

98. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) [2 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).

99. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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).

100. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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).

101. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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).

102. Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) [< or = 1 day]

     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).

103. Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) [>1 to 30 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 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).

104. Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) [31 to 365 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 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).

105. Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) [366 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 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).

106. Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) [731 to 1095 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 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).

107. Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) [366-1095 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 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).

108. Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) [1096-1460 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 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).

109. Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) [1461-1825 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 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).

110. Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) [1096-1825 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 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).

111. Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis [0-1825 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 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).

112. In-Device Minimum Lumen Diameter (MLD) [1 year]

     Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

113. In-Segment Minimum Lumen Diameter (MLD) [1 year]

     Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

114. Proximal Minimum Lumen Diameter (MLD) [1 year]

     Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

115. Distal Minimum Lumen Diameter (MLD) [1 year]

     Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

116. In-Segment Percent Diameter Stenosis (%DS) [1 year]

     The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

117. In-Device Percent Diameter Stenosis (%DS) [1 year]

     The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

118. Proximal Percent Diameter Stenosis (%DS) [1 year]

     The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

119. Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR) [1 year]

     Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

120. Distal Percent Diameter Stenosis (%DS) [1 year]

     The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

121. Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR) [1 year]

     Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

122. Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR) [1 year]

     Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

123. In-Segment Late Loss (LL) [1 year]

     In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

124. Percentage of Participants With Distal Angiographic Binary Restenosis (ABR) [1 year]

     Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

125. In-Device Late Loss (LL) [1 year]

     In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

126. Proximal Late Loss (LL) [1 year]

     Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

127. Distal Late Loss (LL) [1 year]

     Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be at least 18 years of age at the time of signing the informed consent form.

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

3. Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.

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

5. Female subject of childbearing potential 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 14 days (≤14 days) prior to the index procedure per site standard test.

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

7. Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.

2. Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

3. Subject has a known allergic reaction, hypersensitivity or contraindication to:

4. Aspirin; or

5. All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or

6. Heparin and bivalirudin.

7. Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.

8. Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

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

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

11. Subject likely to become hemodynamically unstable due to their arrhythmia.

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

13. Subject has a known left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.

14. Subject has received CABG at any time in the past.

15. Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.

16. Subject requires future staged PCI either in target or non-target vessels.

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

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

19. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.

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

21. Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents).

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

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

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

25. Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions.

26. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).

27. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used.

28. Subject has life expectancy < 2 years for any non-cardiac cause or cardiac cause.

29. 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.

30. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures.

Angiographic Inclusion Criteria

Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required.

1. One or two de novo target lesions:

2. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.

3. If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.

4. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.

5. Target lesion 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, stress test), unstable angina or post-infarct angina.

6. Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) ≥ 2.50 mm and ≤ 3.75 mm (on-line QCA assessment is recommended).

7. Target lesion must have a lesion length ≤ 24 mm based on either visual estimation or on-line QCA.

Angiographic Exclusion Criteria

All exclusion criteria apply to the target lesion(s) or target vessel(s). All exclusion criteria are based on visual estimation.

1. Target lesion is located in left main.

2. Aorto-ostial RCA target lesion (within 3 mm of the ostium).

3. Target lesion located within 3 mm of the origin of the LAD or LCX.

4. Lesion involving a bifurcation with a:

5. Side branch ≥ 2 mm in diameter, or

6. Side branch with diameter stenosis ≥ 50%, or

7. Side branch requiring protection guide wire, or

8. Side branch requiring pre-dilatation

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

XIENCE V, including:

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

4. Target lesion or target vessel involves a myocardial bridge.

5. Target vessel contains thrombus as indicated in the angiographic images.

6. Target vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE V would need to cross the stent to reach the target lesion.

7. Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.

8. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

9. Residual %DS is < 40% (per visual estimation), ≤ 20% is strongly recommended.

10. TIMI Grade-3 flow (per visual estimation).

11. No angiographic complications (e.g. distal embolization, side branch closure).

12. No dissections National Heart, Lung, and Blood Institute (NHLBI) grade D-F.

13. No chest pain lasting > 5 minutes.

14. No ST depression or elevation lasting > 5 minutes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Gao Runlin, MD, FACC, Fu Wai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01923740
• Other Study ID Numbers: 12-397
• First Posted: Aug 16, 2013
• Last Update Posted: Dec 4, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Abbott Medical Devices: Absorb™ BVS; Angioplasty; Bioabsorbable; BVS; Bioresorbable; Coronary Artery Disease; Coronary Artery Endothelial Responsiveness; Coronary artery restenosis; Coronary artery stenosis; Coronary scaffold; Coronary Stent; Drug eluting stents; Everolimus; Myocardial ischemia; Stent thrombosis; Stents
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	The enrollment of the ABSORB China RCT began on July 31, 2013 & completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241&XIENCE:239) at 24 clinical sites in mainland China. Last subject completed the 5 year follow-up on March 7, 2019.
Pre-assignment Detail	Of the 480 ITT subjects, 21 were excluded from the PTE population due to pre-specified protocol/treatment deviations or due to subject withdrawal prior to any study device attempts during the index procedure. Thus, of the 459 subjects in the PTE population, 227 were randomized to the Absorb BVS arm and 232 were randomized to the XIENCE V arm

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Period Title: Overall Study
STARTED	227	232
COMPLETED	221	223
NOT COMPLETED	6	9

Baseline Characteristics

Arm/Group Title	Absorb BVS System	XIENCE V EECSS	Total
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V	Total of all reporting groups
Overall Participants	227	232	459
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (11.4)	57.7 (9.6)	57.4 (10.5)
Sex: Female, Male (Count of Participants)
Female	66 29.1%	61 26.3%	127 27.7%
Male	161 70.9%	171 73.7%	332 72.3%
Region of Enrollment (Count of Participants)
China	227 100%	232 100%	459 100%

Outcome Measures

1. Primary Outcome

Title	In-segment Late Loss (LL) - Per Subject Analysis
Description	In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	196
Mean (Standard Deviation) [Millimeter]	0.19 (0.38)	0.13 (0.38)

2. Primary Outcome

Title	In-segment Late Loss (LL) - Per Lesion Analysis
Description	In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	196
Measure Target lesions	212	209
Mean (Standard Deviation) [Millimeter]	0.19 (0.40)	0.13 (0.37)

3. Secondary Outcome

Title	Acute Device Success
Description	Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time Frame	< or = 1 day

Outcome Measure Data

Analysis Population Description

Intent to treat set (ITT). Four subjects (1 in the Absorb BVS arm and 3 in the XIENCE V arm) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts,3 in the Absorb BVS arm and 2 in the XIENCE V arm were excluded from all data analyses.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	237	234
Measure Target lesions	250	249
Number [Percentage of target lesions]	98.0	99.6

4. Secondary Outcome

Title	Number of Participants With Acute Procedural Success
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 assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time Frame	At time of procedure up to 7 days in hospital

Outcome Measure Data

Analysis Population Description

ITT set. Four subjects (Absorb BVS (1) arm and XIENCE V arm (3)) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts. Data from these 5 subjects (3 in the Absorb BVS arm and 2 in the XIENCE V arm) were excluded from all data analyses.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	237	234
Count of Participants [Participants]	230 101.3%	230 99.1%

5. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	0 0%	0 0%

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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	0 to 37days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	0 0%	0 0%

7. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	0 0%	3 1.3%

8. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	0 0%	4 1.7%

9. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	0 0%	4 1.7%

10. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	1 0.4%	5 2.2%

11. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	2 0.9%	5 2.2%

12. 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	4 1.8%	7 3%

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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	6 2.6%	7 3%

14. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

15. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment-Evaluable Population. Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

16. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	4 1.7%

17. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	4 1.7%

18. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	3 1.3%	4 1.7%

19. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	5 2.2%	5 2.2%

20. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	6 2.6%	5 2.2%

21. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	7 3.1%	6 2.6%

22. Secondary Outcome

Title	Number of Participants With Myocardial Infarction
Description	MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	7 3.1%	6 2.6%

23. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

24. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

25. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	4 1.7%

26. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	1 0.4%

27. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	7 3.1%	7 3%

28. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	9 4%	8 3.4%

29. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	11 4.8%	8 3.4%

30. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	12 5.3%	9 3.9%

31. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Ischemia-driven TLR (ID-TLR) Not ischemia-driven TLR (NID-TLR)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	12 5.3%	9 3.9%

32. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

33. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

34. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	1 0.4%

35. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	1 0.4%

36. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	9 4%	12 5.2%

37. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	11 4.8%	13 5.6%

38. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	14 6.2%	13 5.6%

39. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	16 7%	16 6.9%

40. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Ischemia-driven TVR (ID-TVR) Not ischemia-driven TVR (NID-TVR)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	16 7%	16 6.9%

41. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

42. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	0 to 37days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	0 0%

43. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	1 0.4%

44. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	0 to 298 Days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	2 0.9%

45. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	16 7%	17 7.3%

46. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	21 9.3%	20 8.6%

47. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	24 10.6%	21 9.1%

48. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	27 11.9%	26 11.2%

49. Secondary Outcome

Title	Number of Participants With All Coronary Revascularization (PCI and CABG)
Description	All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	28 12.3%	26 11.2%

50. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

51. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

52. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	6 2.6%

53. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	6 2.6%

54. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	3 1.3%	6 2.6%

55. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	6 2.6%	8 3.4%

56. Secondary Outcome

Title	Number of Death/All MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	8 3.5%	8 3.4%

57. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	11 4.8%	10 4.3%

58. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	13 5.7%	10 4.3%

59. Secondary Outcome

Title	Number of 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	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

60. Secondary Outcome

Title	Number of 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	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

61. Secondary Outcome

Title	Number of 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	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	4 1.7%

62. Secondary Outcome

Title	Number of 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	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	4 1.7%

63. Secondary Outcome

Title	Number of 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	3 1.3%	4 1.7%

64. Secondary Outcome

Title	Number of 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 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	6 2.6%	5 2.2%

65. Secondary Outcome

Title	Number of 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	7 3.1%	5 2.2%

66. Secondary Outcome

Title	Number of 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	9 4%	6 2.6%

67. Secondary Outcome

Title	Number of 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	10 4.4%	6 2.6%

68. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

69. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

70. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	7 3%

71. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	8 3.4%

72. Secondary Outcome

Title	Number of Participants With All 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	17 7.5%	22 9.5%

73. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	22 9.7%	26 11.2%

74. Secondary Outcome

Title	Number of Participants With All 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	26 11.5%	27 11.6%

75. Secondary Outcome

Title	Number of Participants With All 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	31 13.7%	34 14.7%

76. Secondary Outcome

Title	Number of Participants With All 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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	34 15%	34 14.7%

77. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

78. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	2 0.9%

79. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	4 1.7%

80. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	5 2.2%

81. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	7 3.1%	9 3.9%

82. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	9 4%	10 4.3%

83. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	12 5.3%	10 4.3%

84. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	15 6.6%	12 5.2%

85. Secondary Outcome

Title	Number of Participants With Cardiac Death/TV-MI/ID-TLR [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	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	16 7%	12 5.2%

86. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	≤ 7 days post index procedure (In-hospital)

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

87. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

88. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	5 2.2%

89. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	5 2.2%

90. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	8 3.5%	13 5.6%

91. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	2 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	11 4.8%	15 6.5%

92. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	3 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	14 6.2%	15 6.5%

93. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	4 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	18 7.9%	19 8.2%

94. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TVR [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	5 years

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	19 8.4%	19 8.2%

95. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	1 0.4%	2 0.9%

96. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	2 0.9%	3 1.3%

97. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	0 to 208 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	5 2.2%

98. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).
Time Frame	0 to 298 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Count of Participants [Participants]	3 1.3%	5 2.2%

99. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	232
Count of Participants [Participants]	7 3.1%	9 3.9%

100. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	10 4.4%	11 4.7%

101. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	230
Count of Participants [Participants]	13 5.7%	11 4.7%

102. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	230
Count of Participants [Participants]	16 7%	13 5.6%

103. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Count of Participants [Participants]	17 7.5%	13 5.6%

104. Secondary Outcome

Title	Number of Participants With Acute Stent/Scaffold 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	< or = 1 day

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Definite	0 0%	0 0%
Probable	0 0%	0 0%

105. Secondary Outcome

Title	Number of Participants With Subacute Stent/Scaffold 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	>1 to 30 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	227	232
Definite	0 0%	0 0%
Probable	1 0.4%	0 0%

106. Secondary Outcome

Title	Number of Participants With Late Stent/Scaffold 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	31 to 365 days

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	226	228
Definite	0 0%	0 0%
Probable	0 0%	0 0%

107. Secondary Outcome

Title	Number of Participants With Very Late 1 to 2 Year Stent/Scaffold 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	366 to 730 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	225	225
Definite	1 0.4%	0 0%
Probable	0 0%	0 0%

108. Secondary Outcome

Title	Number of Participants With Very Late 2 to 3 Year Stent/Scaffold 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	731 to 1095 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	223	225
Definite	0 0%	0 0%
Probable	0 0%	0 0%

109. Secondary Outcome

Title	Number of Participants With Very Late 1 to 3 Year Stent/Scaffold 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	366-1095 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	224	225
Definite	1 0.4%	0 0%
Probable	0 0%	0 0%

110. Secondary Outcome

Title	Number of Participants With Very Late 3 to 4 Year Stent/Scaffold 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	1096-1460 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	221	223
Definite	0 0%	0 0%
Probable	1 0.4%	1 0.4%

111. Secondary Outcome

Title	Number of Participants With Very Late 4 to 5 Year Stent/Scaffold 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	1461-1825 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	216	215
Definite	0 0%	0 0%
Probable	0 0%	0 0%

112. Secondary Outcome

Title	Number of Participants With Very Late 3 to 5 Year Stent/Scaffold 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	1096-1825 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	217	216
Definite	0 0%	0 0%
Probable	1 0.4%	1 0.4%

113. Secondary Outcome

Title	Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis
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	0-1825 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	218	216
Definite	1 0.4%	0 0%
Probable	2 0.9%	1 0.4%

114. Secondary Outcome

Title	In-Device Minimum Lumen Diameter (MLD)
Description	Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Mean (Standard Deviation) [Millimeter]	2.24 (0.48)	2.50 (0.46)

115. Secondary Outcome

Title	In-Segment Minimum Lumen Diameter (MLD)
Description	Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Mean (Standard Deviation) [Millimeter]	2.11 (0.47)	2.17 (0.49)

116. Secondary Outcome

Title	Proximal Minimum Lumen Diameter (MLD)
Description	Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment-Evaluable Population (PTE) Population. Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	198	192
Measure Target lesions	208	205
Mean (Standard Deviation) [Millimeter]	2.64 (0.48)	2.68 (0.56)

117. Secondary Outcome

Title	Distal Minimum Lumen Diameter (MLD)
Description	Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	199	196
Measure Target lesions	210	209
Mean (Standard Deviation) [Millimeter]	2.39 (0.45)	2.37 (0.50)

118. Secondary Outcome

Title	In-Segment Percent Diameter Stenosis (%DS)
Description	The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Mean (Standard Deviation) [Percent Diameter stenosis]	24.02 (13.23)	22.96 (13.18)

119. Secondary Outcome

Title	In-Device Percent Diameter Stenosis (%DS)
Description	The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Mean (Standard Deviation) [Percent Diameter stenosis]	19.16 (14.36)	11.15 (11.38)

120. Secondary Outcome

Title	Proximal Percent Diameter Stenosis (%DS)
Description	The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	198	192
Measure Target lesions	208	205
Mean (Standard Deviation) [Percent Diameter stenosis]	11.09 (10.13)	12.12 (11.63)

121. Secondary Outcome

Title	Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)
Description	Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	198	192
Measure Target lesions	208	205
Number [Percentage of participants]	1.0 0.4%	1.5 0.6%

122. Secondary Outcome

Title	Distal Percent Diameter Stenosis (%DS)
Description	The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	199	196
Measure Target lesions	210	209
Mean (Standard Deviation) [Percent Diameter stenosis]	8.53 (8.15)	8.14 (11.86)

123. Secondary Outcome

Title	Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)
Description	Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Number [percentage of participants]	4.2 1.9%	2.9 1.3%

124. Secondary Outcome

Title	Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)
Description	Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	197
Measure Target lesions	212	210
Number [Percentage of participants]	3.3 1.5%	1.0 0.4%

125. Secondary Outcome

Title	In-Segment Late Loss (LL)
Description	In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	196
Measure Target lesions	212	209
Mean (Standard Deviation) [Millimeter]	0.19 (0.40)	0.13 (0.37)

126. Secondary Outcome

Title	Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)
Description	Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	199	196
Measure Target lesions	210	209
Number [Percentage of participants]	0.0 0%	1.0 0.4%

127. Secondary Outcome

Title	In-Device Late Loss (LL)
Description	In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	200	196
Measure Target lesions	212	209
Mean (Standard Deviation) [Millimeter]	0.24 (0.39)	0.10 (0.32)

128. Secondary Outcome

Title	Proximal Late Loss (LL)
Description	Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	196	185
Measure Target lesions	205	198
Mean (Standard Deviation) [Millimeter]	0.19 (0.39)	0.13 (0.42)

129. Secondary Outcome

Title	Distal Late Loss (LL)
Description	Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Arm/Group Title	Absorb BVS System	XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS: Subjects receiving XIENCE V
Measure Participants	199	194
Measure Target lesions	210	207
Mean (Standard Deviation) [Millimeter]	0.08 (0.31)	0.03 (0.33)

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	PTE population.
Arm/Group Title	Absorb BVS System		XIENCE V EECSS
Arm/Group Description	Absorb BVS System: Subjects receiving Absorb BVS System		XIENCE V EECSS: Subjects receiving XIENCE V
All Cause Mortality
	Absorb BVS System		XIENCE V EECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/227 (2.6%)		7/232 (3%)
Serious Adverse Events
	Absorb BVS System		XIENCE V EECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/227 (41.4%)		81/232 (34.9%)
Cardiac disorders
Atrial fibrillation	2/227 (0.9%)		2/232 (0.9%)
Coronary artery dissection	4/227 (1.8%)		5/232 (2.2%)
Coronary artery stenosis	10/227 (4.4%)		8/232 (3.4%)
Myocardial infarction	4/227 (1.8%)		2/232 (0.9%)
Palpitations	1/227 (0.4%)		0/232 (0%)
Ventricular arrhythmia	0/227 (0%)		1/232 (0.4%)
Acute coronary syndrome	1/227 (0.4%)		0/232 (0%)
Acute myocardial infarction	1/227 (0.4%)		2/232 (0.9%)
Angina pectoris	12/227 (5.3%)		5/232 (2.2%)
Angina unstable	15/227 (6.6%)		10/232 (4.3%)
Cardiac failure	3/227 (1.3%)		0/232 (0%)
Coronary artery disease	11/227 (4.8%)		4/232 (1.7%)
Extrasystoles	0/227 (0%)		1/232 (0.4%)
Myocardial ischaemia	1/227 (0.4%)		0/232 (0%)
Sinus bradycardia	1/227 (0.4%)		0/232 (0%)
Ventricular extrasystoles	1/227 (0.4%)		0/232 (0%)
Ischaemic Cardiomyopathy	1/227 (0.4%)		0/232 (0%)
Ear and labyrinth disorders
Meniere's disease	1/227 (0.4%)		0/232 (0%)
Deafness unilateral	1/227 (0.4%)		0/232 (0%)
Sudden hearing loss	0/227 (0%)		1/232 (0.4%)
Middle Ear Inflammation	0/227 (0%)		1/232 (0.4%)
Endocrine disorders
Goitre	0/227 (0%)		1/232 (0.4%)
Eye disorders
Cataract	1/227 (0.4%)		1/232 (0.4%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	0/227 (0%)		3/232 (1.3%)
Hematochezia	0/227 (0%)		1/232 (0.4%)
Intestinal obstruction	2/227 (0.9%)		1/232 (0.4%)
Gastric ulcer	0/227 (0%)		1/232 (0.4%)
Haemorrhoids	1/227 (0.4%)		0/232 (0%)
Inguinal hernia	0/227 (0%)		1/232 (0.4%)
Periodontal disease	0/227 (0%)		1/232 (0.4%)
Adverse drug reaction	0/227 (0%)		1/232 (0.4%)
Constipation	1/227 (0.4%)		0/232 (0%)
Intestinal Polyp	1/227 (0.4%)		0/232 (0%)
General disorders
Application site hematoma	1/227 (0.4%)		0/232 (0%)
Chest discomfort	8/227 (3.5%)		5/232 (2.2%)
Chest pain	2/227 (0.9%)		1/232 (0.4%)
Drug resistance	1/227 (0.4%)		0/232 (0%)
Mass	0/227 (0%)		1/232 (0.4%)
Non-cardiac chest pain	3/227 (1.3%)		4/232 (1.7%)
Hepatobiliary disorders
Cholangitis acute	0/227 (0%)		1/232 (0.4%)
Bile duct stone	0/227 (0%)		2/232 (0.9%)
Cholelithiasis	0/227 (0%)		2/232 (0.9%)
Infections and infestations
Appendicitis	1/227 (0.4%)		0/232 (0%)
Lung infection	2/227 (0.9%)		1/232 (0.4%)
Pneumonia	1/227 (0.4%)		2/232 (0.9%)
Bronchitis	1/227 (0.4%)		0/232 (0%)
Gastroenteritis	0/227 (0%)		1/232 (0.4%)
Pulmonary Tuberculosis	1/227 (0.4%)		0/232 (0%)
Injury, poisoning and procedural complications
Coronary artery restenosis	9/227 (4%)		11/232 (4.7%)
Electric injury	0/227 (0%)		1/232 (0.4%)
Joint injury	1/227 (0.4%)		0/232 (0%)
Post procedural myocardial infarction	1/227 (0.4%)		0/232 (0%)
Procedural hypotension	1/227 (0.4%)		0/232 (0%)
Thoracic vertebral fracture	1/227 (0.4%)		0/232 (0%)
Investigations
Arteriogram coronary	1/227 (0.4%)		0/232 (0%)
Blood glucose increased	0/227 (0%)		1/232 (0.4%)
Physical examination	0/227 (0%)		1/232 (0.4%)
Metabolism and nutrition disorders
Diabetes mellitus	2/227 (0.9%)		0/232 (0%)
Diabetes mellitus inadequate control	1/227 (0.4%)		0/232 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/227 (0%)		1/232 (0.4%)
Muscle atrophy	1/227 (0.4%)		0/232 (0%)
Juvenile arthritis	0/227 (0%)		1/232 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant	0/227 (0%)		1/232 (0.4%)
Gastrointestinal stromal tumor	0/227 (0%)		1/232 (0.4%)
Bile duct cancer	0/227 (0%)		1/232 (0.4%)
Breast cancer	0/227 (0%)		1/232 (0.4%)
Glomus tumour	0/227 (0%)		1/232 (0.4%)
Lung neoplasm malignent	1/227 (0.4%)		0/232 (0%)
Renal cell carcinoma	1/227 (0.4%)		0/232 (0%)
Squamous cell carcinoma	0/227 (0%)		1/232 (0.4%)
Nervous system disorders
Carotid artery disease	1/227 (0.4%)		0/232 (0%)
Cerebral atrophy	1/227 (0.4%)		0/232 (0%)
Cerebrovascular disorder	0/227 (0%)		1/232 (0.4%)
Subarachnoid hemorrhage	1/227 (0.4%)		0/232 (0%)
Brain oedema	0/227 (0%)		1/232 (0.4%)
Brain stem infarction	1/227 (0.4%)		0/232 (0%)
Carotid artery stenosis	0/227 (0%)		1/232 (0.4%)
Cerebral artery occlusion	1/227 (0.4%)		0/232 (0%)
Cerebral infarction	2/227 (0.9%)		2/232 (0.9%)
Lacunar infarction	1/227 (0.4%)		0/232 (0%)
Parkinson's disease	1/227 (0.4%)		0/232 (0%)
Syncope	1/227 (0.4%)		0/232 (0%)
Cerebral Haemorrhage	1/227 (0.4%)		0/232 (0%)
Ischaemic Stroke	1/227 (0.4%)		0/232 (0%)
Neuromyelitis Optica	1/227 (0.4%)		0/232 (0%)
Renal and urinary disorders
Calculus ureteric	0/227 (0%)		1/232 (0.4%)
Nephrolithiasis	1/227 (0.4%)		2/232 (0.9%)
Renal disorder	0/227 (0%)		1/232 (0.4%)
Renal failure chronic	1/227 (0.4%)		0/232 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/227 (0.4%)		0/232 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/227 (0.4%)		0/232 (0%)
Epistaxis	0/227 (0%)		1/232 (0.4%)
Pulmonary congestion	0/227 (0%)		1/232 (0.4%)
Vascular disorders
Hypertension	4/227 (1.8%)		0/232 (0%)
Other (Not Including Serious) Adverse Events
	Absorb BVS System		XIENCE V EECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	151/227 (66.5%)		135/232 (58.2%)
Blood and lymphatic system disorders
Anaemia	0/227 (0%)		1/232 (0.4%)
Leukopenia	1/227 (0.4%)		0/232 (0%)
Cardiac disorders
Angina pectoris	28/227 (12.3%)		16/232 (6.9%)
Arteriosclerosis coronary artery	0/227 (0%)		1/232 (0.4%)
Atrial fibrillation	2/227 (0.9%)		3/232 (1.3%)
Acute coronary syndrome	1/227 (0.4%)		0/232 (0%)
Coronary artery dissection	4/227 (1.8%)		5/232 (2.2%)
Coronary artery stenosis	10/227 (4.4%)		8/232 (3.4%)
Coronary artery disease	12/227 (5.3%)		4/232 (1.7%)
Acute myocardial infarction	1/227 (0.4%)		2/232 (0.9%)
Cardiac disorder	1/227 (0.4%)		0/232 (0%)
Cardiac failure	3/227 (1.3%)		0/232 (0%)
Myocardial infarction	4/227 (1.8%)		2/232 (0.9%)
Myocardial ischaemia	1/227 (0.4%)		0/232 (0%)
Palpitations	3/227 (1.3%)		4/232 (1.7%)
Extrasystoles	0/227 (0%)		1/232 (0.4%)
Angina unstable	16/227 (7%)		12/232 (5.2%)
Ventricular arrhythmia	0/227 (0%)		1/232 (0.4%)
Sinus bradycardia	1/227 (0.4%)		0/232 (0%)
Ventricular extrasystoles	1/227 (0.4%)		0/232 (0%)
Ischaemic Cardiomyopathy	1/227 (0.4%)		0/232 (0%)
Ear and labyrinth disorders
Meniere's disease	1/227 (0.4%)		0/232 (0%)
Deafness neurosensory	1/227 (0.4%)		0/232 (0%)
Deafness unilateral	1/227 (0.4%)		0/232 (0%)
Sudden hearing loss	0/227 (0%)		1/232 (0.4%)
Middle Ear Inflammation	0/227 (0%)		1/232 (0.4%)
Endocrine disorders
Goitre	0/227 (0%)		1/232 (0.4%)
Eye disorders
Cataract	1/227 (0.4%)		1/232 (0.4%)
Xerophthalmia	1/227 (0.4%)		0/232 (0%)
Conjunctival haemorrhage	1/227 (0.4%)		0/232 (0%)
Gastrointestinal disorders
Aphthous stomatitis	1/227 (0.4%)		0/232 (0%)
Faeces discoloured	1/227 (0.4%)		0/232 (0%)
Duodenal ulcer	1/227 (0.4%)		0/232 (0%)
Enteritis	1/227 (0.4%)		0/232 (0%)
Gastrointestinal haemorrhage	0/227 (0%)		3/232 (1.3%)
Hematochezia	1/227 (0.4%)		1/232 (0.4%)
Intestinal obstruction	2/227 (0.9%)		1/232 (0.4%)
Tooth socket haemorrhage	0/227 (0%)		3/232 (1.3%)
Gastric ulcer	0/227 (0%)		1/232 (0.4%)
Gastritis	0/227 (0%)		1/232 (0.4%)
Gingivitis	1/227 (0.4%)		0/232 (0%)
Haemorrhoids	1/227 (0.4%)		0/232 (0%)
Inguinal hernia	0/227 (0%)		1/232 (0.4%)
Periodontal disease	0/227 (0%)		1/232 (0.4%)
Vomiting	1/227 (0.4%)		0/232 (0%)
Constipation	1/227 (0.4%)		0/232 (0%)
Intestinal Polyp	1/227 (0.4%)		0/232 (0%)
Intestinal Obstruction	0/227 (0%)		1/232 (0.4%)
General disorders
Application site haematoma	1/227 (0.4%)		0/232 (0%)
Catheter site haemorrhage	1/227 (0.4%)		0/232 (0%)
Chest discomfort	25/227 (11%)		14/232 (6%)
Non-cardiac chest pain	8/227 (3.5%)		11/232 (4.7%)
Chest pain	2/227 (0.9%)		2/232 (0.9%)
Irritability	1/227 (0.4%)		0/232 (0%)
Drug resistance	1/227 (0.4%)		0/232 (0%)
Mass	0/227 (0%)		1/232 (0.4%)
Sensation of foreign body	1/227 (0.4%)		0/232 (0%)
Adverse drug reaction	0/227 (0%)		2/232 (0.9%)
Pain	1/227 (0.4%)		0/232 (0%)
Oedema peripheral	1/227 (0.4%)		0/232 (0%)
Hepatobiliary disorders
Cholangitis acute	0/227 (0%)		1/232 (0.4%)
Bile duct stone	0/227 (0%)		2/232 (0.9%)
Cholelithiasis	1/227 (0.4%)		3/232 (1.3%)
Immune system disorders
Hypersensitivity	1/227 (0.4%)		0/232 (0%)
Infections and infestations
Appendicitis	1/227 (0.4%)		0/232 (0%)
Bronchitis	2/227 (0.9%)		1/232 (0.4%)
Gastroenteritis	4/227 (1.8%)		2/232 (0.9%)
Lung infection	2/227 (0.9%)		1/232 (0.4%)
Pneumonia	1/227 (0.4%)		2/232 (0.9%)
Respiratory tract infection	1/227 (0.4%)		0/232 (0%)
Herpes virus infection	1/227 (0.4%)		0/232 (0%)
Nasopharyngitis	0/227 (0%)		1/232 (0.4%)
Rhinitis	1/227 (0.4%)		0/232 (0%)
Skin infection	0/227 (0%)		1/232 (0.4%)
Tracheitis	0/227 (0%)		1/232 (0.4%)
Vaginal infection	1/227 (0.4%)		0/232 (0%)
Upper respiratory tract infection	3/227 (1.3%)		3/232 (1.3%)
Pulmonary Tuberculosis	1/227 (0.4%)		0/232 (0%)
Injury, poisoning and procedural complications
Coronary artery restenosis	9/227 (4%)		11/232 (4.7%)
Electric injury	0/227 (0%)		1/232 (0.4%)
Joint injury	1/227 (0.4%)		0/232 (0%)
Post procedural myocardial infarction	1/227 (0.4%)		0/232 (0%)
Procedural vomiting	1/227 (0.4%)		0/232 (0%)
Procedural hypotension	1/227 (0.4%)		0/232 (0%)
Contusion	1/227 (0.4%)		0/232 (0%)
Fall	0/227 (0%)		1/232 (0.4%)
Laceration	1/227 (0.4%)		0/232 (0%)
Soft tissue injury	0/227 (0%)		1/232 (0.4%)
Thoracic vertebral fracture	1/227 (0.4%)		0/232 (0%)
Investigations
Blood pressure increased	1/227 (0.4%)		1/232 (0.4%)
Cardiac enzymes increased	10/227 (4.4%)		9/232 (3.9%)
Blood creatine phosphokinase MB increased	7/227 (3.1%)		4/232 (1.7%)
Blood creatine phosphokinase increased	5/227 (2.2%)		4/232 (1.7%)
Blood creatinine increased	1/227 (0.4%)		0/232 (0%)
Troponin I increased	25/227 (11%)		32/232 (13.8%)
Troponin T increased	1/227 (0.4%)		0/232 (0%)
Troponin increased	0/227 (0%)		1/232 (0.4%)
Arteriogram coronary	1/227 (0.4%)		0/232 (0%)
Blood glucose increased	0/227 (0%)		1/232 (0.4%)
Physical examination	0/227 (0%)		1/232 (0.4%)
Transaminases increased	0/227 (0%)		1/232 (0.4%)
Metabolism and nutrition disorders
Diabetes mellitus	2/227 (0.9%)		1/232 (0.4%)
Hyperglycemia	1/227 (0.4%)		0/232 (0%)
Type 2 diabetes mellitus	1/227 (0.4%)		0/232 (0%)
Diabetes mellitus inadequate control	1/227 (0.4%)		0/232 (0%)
Gout	1/227 (0.4%)		0/232 (0%)
Hypoproteinaemia	1/227 (0.4%)		0/232 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/227 (0%)		1/232 (0.4%)
Muscle atrophy	1/227 (0.4%)		0/232 (0%)
Arthralgia	1/227 (0.4%)		0/232 (0%)
Fasciitis	0/227 (0%)		1/232 (0.4%)
Juvenile arthritis	0/227 (0%)		1/232 (0.4%)
Osteoarthritis	0/227 (0%)		2/232 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant	0/227 (0%)		1/232 (0.4%)
Gastrointestinal stromal tumor	0/227 (0%)		1/232 (0.4%)
Bile duct cancer	0/227 (0%)		1/232 (0.4%)
Breast cancer	0/227 (0%)		1/232 (0.4%)
Glomus tumour	0/227 (0%)		1/232 (0.4%)
Lung neoplasm malignant	1/227 (0.4%)		0/232 (0%)
Renal cell carcinoma	1/227 (0.4%)		0/232 (0%)
Squamous cell carcinoma	0/227 (0%)		1/232 (0.4%)
Thyroid neoplasm	0/227 (0%)		1/232 (0.4%)
Nervous system disorders
Aphasia	0/227 (0%)		1/232 (0.4%)
Carotid artery disease	1/227 (0.4%)		0/232 (0%)
Cerebral atrophy	1/227 (0.4%)		0/232 (0%)
Cerebral hemorrhage	1/227 (0.4%)		1/232 (0.4%)
Cerebrovascular disorder	0/227 (0%)		1/232 (0.4%)
Dizziness	2/227 (0.9%)		2/232 (0.9%)
Brain oedema	0/227 (0%)		1/232 (0.4%)
Subarachnoid hemorrhage	1/227 (0.4%)		0/232 (0%)
Brain stem infarction	1/227 (0.4%)		0/232 (0%)
Carotid artery stenosis	0/227 (0%)		1/232 (0.4%)
Cerebral artery occlusion	1/227 (0.4%)		0/232 (0%)
Cerebral infarction	2/227 (0.9%)		2/232 (0.9%)
Hypoaesthesia	1/227 (0.4%)		0/232 (0%)
Lacunar infarction	1/227 (0.4%)		0/232 (0%)
Parkinson's disease	1/227 (0.4%)		0/232 (0%)
Syncope	1/227 (0.4%)		0/232 (0%)
Ischaemic Stroke	1/227 (0.4%)		0/232 (0%)
Neuromyelitis Optica	1/227 (0.4%)		0/232 (0%)
Psychiatric disorders
Anxiety disorder	1/227 (0.4%)		1/232 (0.4%)
Depression	1/227 (0.4%)		0/232 (0%)
Renal and urinary disorders
Haematuria	2/227 (0.9%)		0/232 (0%)
Calculus ureteric	0/227 (0%)		1/232 (0.4%)
Nephrolithiasis	2/227 (0.9%)		2/232 (0.9%)
Renal disorder	0/227 (0%)		1/232 (0.4%)
Renal failure chronic	1/227 (0.4%)		0/232 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/227 (0.4%)		0/232 (0%)
Breast pain	0/227 (0%)		1/232 (0.4%)
Respiratory, thoracic and mediastinal disorders
Cough	1/227 (0.4%)		1/232 (0.4%)
Dyspnea exertional	1/227 (0.4%)		0/232 (0%)
Chronic obstructive pulmonary disease	1/227 (0.4%)		0/232 (0%)
Dyspnoea	1/227 (0.4%)		0/232 (0%)
Epistaxis	1/227 (0.4%)		1/232 (0.4%)
Hiccups	1/227 (0.4%)		0/232 (0%)
Pulmonary congestion	1/227 (0.4%)		1/232 (0.4%)
Skin and subcutaneous tissue disorders
Ecchymosis	2/227 (0.9%)		3/232 (1.3%)
Hemorrhage subcutaneous	1/227 (0.4%)		0/232 (0%)
Rash	1/227 (0.4%)		0/232 (0%)
Vascular disorders
Hypertension	4/227 (1.8%)		0/232 (0%)
Hypotension	0/227 (0%)		1/232 (0.4%)
Venous thrombosis limb	0/227 (0%)		1/232 (0.4%)
Aortic aneurysm	1/227 (0.4%)		0/232 (0%)
Hypertensive crisis	0/227 (0%)		1/232 (0.4%)

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.