EXCEL Clinical Trial

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01205776
• Collaborator: (none)
• Enrollment: 1,905
• Location: 1
• Arms: 2
• Actual Duration (Months): 104.9
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

Condition or Disease	Intervention/Treatment	Phase
Chronic Coronary Occlusion; Unprotected Left Main Coronary Artery Disease; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: Percutaneous Coronary Intervention; Procedure: CABG	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1905 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.
• Actual Study Start Date: Sep 29, 2010
• Actual Primary Completion Date: May 3, 2019
• Actual Study Completion Date: Jun 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Percutaneous Coronary Intervention Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Device: Percutaneous Coronary Intervention; Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Active Comparator: Coronary Artery Bypass Graft Those patients receiving CABG	Procedure: CABG; Those patients receiving CABG

Outcome Measures

Primary Outcome Measures

1. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [5 years]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

Secondary Outcome Measures

1. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [In-hospital (≤ 7 days of index-procedure)]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

2. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [30 days]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

3. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 6 months]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

4. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 1 year]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

5. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 2 years]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

6. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 3 years]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

7. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 4 years]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

8. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [0 to 5 years]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

9. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [In-hospital (≤ 7 days of index-procedure)]

   All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

10. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 30 days]

    All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

11. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 6 months]

    All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

12. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 1 year]

    All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

13. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 2 years]

    All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

14. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 3 years]

    Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.

15. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 4 years]

    Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.

16. Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [0 to 5 years]

    Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.

17. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [In-hospital (≤ 7 days of index-procedure)]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

18. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 30 days]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

19. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 6 months]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

20. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 1 year]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

21. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 2 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

22. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 3 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

23. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 4 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

24. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [0 to 5 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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.

25. Number of Participants With Protocol Defined MI [In-hospital (≤ 7 days of post index procedure)]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

26. Number of Participants With Protocol Defined MI [0 to 30 days]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

27. Number of Participants With Protocol Defined MI [0 to 6 months]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

28. Number of Participants With Protocol Defined MI [0 to 1 year]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

29. Number of Participants With Protocol Defined MI [0 to 2 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

30. Number of Participants With Protocol Defined MI [0 to 3 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

31. Number of Participants With Protocol Defined MI [0 to 4 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

32. Number of Participants With Protocol Defined MI [0 to 5 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

33. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [In-hospital (≤ 7 days of index-procedure)]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

34. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 30 days]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

35. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 6 months]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

36. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 1 year]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

37. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 2 years]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

38. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 3 years]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

39. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 4 years]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

40. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [0 to 5 years]

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.

41. Number of Participants With Disability Following Stroke Event [90 days ± 2 weeks]

    In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale. Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire. Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations. Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention.

42. Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR) [In-hospital (≤ 7 days of index-procedure)]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

43. Number of Participants With Ischemia Driven Revascularizations [0 to 30 days]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

44. Number of Participants With Ischemia Driven Revascularizations [0 to 6 months]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

45. Number of Participants With Ischemia Driven Revascularizations [0 to 1 year]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

46. Number of Participants With Ischemia Driven Revascularizations [0 to 2 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

47. Number of Participants With Ischemia Driven Revascularizations [0 to 3 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

48. Number of Participants With Ischemia Driven Revascularizations [0 to 4 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

49. Number of Participants With Ischemia Driven Revascularizations [0 to 5 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80

50. Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven) [In-hospital (≤ 7 days of index-procedure)]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

51. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 30 days]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

52. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 6 months]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

53. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 1 year]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

54. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 2 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

55. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 3 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

56. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 4 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

57. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [0 to 5 years]

    A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

58. Percentage of Participants With Major Adverse Events (MAE) [In-hospital]

    Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.

59. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [Early (0-30 days)]

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

60. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [Acute (<= 24 hours)]

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

61. Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable [Subacute (1-30 days)]

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

62. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [Late (>30 days - 1 year)]

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

63. Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable [Very late (>1 year)]

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

64. Number of Participants With Graft Stenosis or Occlusion [In-hospital (≤ 7 days of index-procedure)]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

65. Number of Participants With Graft Stenosis or Occlusion [0 to 30 days]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

66. Number of Participants With Graft Stenosis or Occlusion [0 to 6 months]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

67. Number of Participants With Graft Stenosis or Occlusion [0 to 1 year]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

68. Number of Participants With Graft Stenosis or Occlusion [0 to 2 years]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

69. Number of Participants With Graft Stenosis or Occlusion [0 to 3 years]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

70. Number of Participants With Graft Stenosis or Occlusion [0 to 4 years]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

71. Number of Participants With Graft Stenosis or Occlusion [0 to 5 years]

    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

72. Number of Participants With Requirement for Blood Product Transfusion [30 days]

    All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].

73. Number of Participants With Requirement for Blood Product Transfusion [3 years]

    All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].

74. Number of Participants With Requirement for Blood Product Transfusion [4 years]

    All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].

75. Number of Participants With Requirement for Blood Product Transfusion [5 years]

    All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].

76. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [30 days]

    Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.

77. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [3 years]

    Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.

78. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [4 years]

    Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.

79. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [5 years]

    Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.

80. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [30 days]

    Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding

81. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [3 years]

    Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding

82. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [4 years]

    Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding

83. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [5 years]

    Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding

84. Number of Participants With Major Adverse Events (MAE) [30 days]

    death myocardial infarction stroke Transfusion of ≥2 units of blood TIMI major or minor bleeding major arrhythmia unplanned coronary revascularization for ischemia any unplanned surgery or therapeutic radiologic procedure renal failure sternal wound dehiscence infection requiring antibiotics for treatment intubation for > 48 hours post-pericardiotomy syndrome

85. Number of Participants With Complete Revascularization (Residual = 0) [At Baseline]

    Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis). -While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.) From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization. Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized). Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.

86. Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion [In-hospital (≤ 7 days of post index procedure)]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

87. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [1 year]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

88. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [2 years]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

89. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [3 years]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

90. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [4 years]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

91. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [5 years]

    - Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Inclusion criteria for RCT:

• Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or

• ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:

• Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or

• IVUS minimum lumen area (MLA) <= 6.0mm2, and/or

• Fractional Flow Reserve (FFR) <=0.80

• Left Main Equivalent Disease

• Clinical and anatomic eligibility for both PCI and CABG

• Silent ischemia, stable angina, unstable angina or recent MI

• Ability to sign informed consent and comply with all study procedures including follow-up for at least three years

Exclusion Criteria:

• Clinical exclusion criteria:

• Prior PCI of the left main trunk at any time prior to randomization

• Prior PCI of any other coronary artery lesions within one year prior to randomization

• Prior CABG at any time prior to randomization

• Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed

• CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated

• Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year

• Subjects requiring or who may require additional surgery within one year

• The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present

• The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present

• Pregnancy or intention to become pregnant

• Non cardiac co-morbidities with life expectancy less than 3 years

• Other investigational drug or device studies that have not reached their primary endpoint

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

Angiographic exclusion criteria:

• Left main diameter stenosis <50%

• SYNTAX score ≥33

• Left main reference vessel diameter <2.25 mm or >4.25 mm

• The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present

• The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present

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: Gregg W Stone, MD, Columbia University
• Principal Investigator: Patrick W Serruys, MD, Erasmus Medical Center
• Principal Investigator: Joseph Sabik, MD, Cleveland Clinical Main Campus
• Principal Investigator: A. Pieter Kappetein, MD, Erasmus Medical Center

Study Documents (Full-Text)

• Study Protocol - Feb 8, 2016
• Statistical Analysis Plan - Jan 26, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01205776
• Other Study ID Numbers: 10-389
• First Posted: Sep 20, 2010
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Abbott Medical Devices: Drug eluting stents; Stents; Unprotected Left Main Coronary Artery Disease; Coronary artery bypass graft surgery
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Thrombosis; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia

Study Results

Participant Flow

Recruitment Details	A total of 1905 subjects were randomized (Percutaneous Coronary Intervention (PCI): 948 & Coronary Artery Bypass Graft (CABG) 957) between September 29, 2010 and March 6, 2014. Five hundred and forty-nine (549) subjects were from 56 U.S. sites and 1356 subjects were from 70 international sites,for a total of 126 enrolling sites.
Pre-assignment Detail	The original EXCEL study consisted of a randomized clinical trial (RCT) (n=2600) & a Universal Registry (n=1000). In February 2014,a decision was made to cap enrollment in the RCT at approximately 1900.The change in scope of the study design was not due to any device or subject safety issues.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Period Title: Overall Study
STARTED	948	957
COMPLETED	884	862
NOT COMPLETED	64	95

Baseline Characteristics

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)	Total
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)	Total of all reporting groups
Overall Participants	948	957	1905
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (9.6)	65.9 (9.5)	66.0 (9.6)
Sex: Female, Male (Count of Participants)
Female	722 76.2%	742 77.5%	1464 76.9%
Male	226 23.8%	215 22.5%	441 23.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	21 2.2%	23 2.4%	44 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	36 3.8%	28 2.9%	64 3.4%
White	844 89%	853 89.1%	1697 89.1%
More than one race	16 1.7%	20 2.1%	36 1.9%
Unknown or Not Reported	31 3.3%	33 3.4%	64 3.4%
Region of Enrollment (Count of Participants)
Europe	534 56.3%	541 56.5%	1075 56.4%
United States	278 29.3%	271 28.3%	549 28.8%
Canada	103 10.9%	100 10.4%	203 10.7%
Southeast Asia	7 0.7%	8 0.8%	15 0.8%
Australia	6 0.6%	9 0.9%	15 0.8%
South America	20 2.1%	28 2.9%	48 2.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	203 21.4%	176 18.4%

2. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	40 4.2%	77 8%

3. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	46 4.9%	75 7.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.
	Method	Com-Nougue
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	66 7%	97 10.1%

5. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	80 8.4%	106 11.1%

6. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	115 12.1%	122 12.7%

7. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	137 14.5%	135 14.1%

8. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	173 18.2%	154 16.1%

9. Secondary Outcome

Title	Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	203 21.4%	176 18.4%

10. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	40 4.2%	82 8.6%

11. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	46 4.9%	80 8.4%

12. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	79 8.3%	112 11.7%

13. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	121 12.8%	129 13.5%

14. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	177 18.7%	154 16.1%

15. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	213 22.5%	176 18.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.
Statistical Test of Hypothesis	p-Value	0.011
	Comments	p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.
	Method	Com-Nougue Approach
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	4.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	260 27.4%	203 21.2%

17. Secondary Outcome

Title	Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description	Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	290 30.6%	228 23.8%

18. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	4 0.4%	12 1.3%

19. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	9 0.9%	10 1%

20. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	19 2%	23 2.4%

21. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	31 3.3%	33 3.4%

22. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	54 5.7%	44 4.6%

23. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	74 7.8%	54 5.6%

24. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	95 10%	68 7.1%

25. Secondary Outcome

Title	Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	119 12.6%	89 9.3%

26. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	In-hospital (≤ 7 days of post index procedure)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	34 3.6%	58 6.1%

27. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	37 3.9%	59 6.2%

28. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	46 4.9%	68 7.1%

29. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	53 5.6%	68 7.1%

30. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	64 6.8%	73 7.6%

31. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	74 7.8%	78 8.2%

32. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	86 9.1%	81 8.5%

33. Secondary Outcome

Title	Number of Participants With Protocol Defined MI
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	95 10%	84 8.8%

34. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	4 0.4%	13 1.4%

35. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	6 0.6%	12 1.3%

36. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	9 0.9%	16 1.7%

37. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	10 1.1%	18 1.9%

38. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	17 1.8%	22 2.3%

39. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	21 2.2%	28 2.9%

40. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	23 2.4%	30 3.1%

41. Secondary Outcome

Title	Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description	Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	26 2.7%	33 3.4%

42. Secondary Outcome

Title	Number of Participants With Disability Following Stroke Event
Description	In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale. Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire. Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations. Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention.
Time Frame	90 days ± 2 weeks

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	17	29
Count of Participants [Participants]	6 0.6%	9 0.9%

43. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	3 0.3%	12 1.3%

44. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	6 0.6%	13 1.4%

45. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	28 3%	29 3%

46. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	62 6.5%	40 4.2%

47. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	95 10%	56 5.9%

48. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	114 12%	67 7%

49. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	143 15.1%	81 8.5%

50. Secondary Outcome

Title	Number of Participants With Ischemia Driven Revascularizations
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	150 15.8%	88 9.2%

51. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	3 0.3%	12 1.3%

52. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	7 0.7%	13 1.4%

53. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	29 3.1%	30 3.1%

54. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	63 6.6%	42 4.4%

55. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	97 10.2%	57 6%

56. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	116 12.2%	68 7.1%

57. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	146 15.4%	83 8.7%

58. Secondary Outcome

Title	Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description	A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	153 16.1%	92 9.6%

59. Secondary Outcome

Title	Percentage of Participants With Major Adverse Events (MAE)
Description	Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.
Time Frame	In-hospital

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Death	0.4 0%	1.3 0.1%
Myocardial infarction	3.6 0.4%	6.2 0.6%
Stroke	0.4 0%	1.4 0.1%
Transfusion of >= 2 units blood	3.5 0.4%	17.1 1.8%
TIMI major or minor bleeding	3.0 0.3%	9.3 1%
Major arrhythmia	1.8 0.2%	14.7 1.5%
Unplanned coronary revascularization for ischemia	0.3 0%	1.3 0.1%
Unplanned surgery/therapeutic radiologic procedure	1.0 0.1%	3.7 0.4%
Renal failure	0.6 0.1%	2.4 0.3%
Sternal wound dehiscence	0.0 0%	1.0 0.1%
Infection requiring antibiotics for treatment	1.2 0.1%	8.8 0.9%
Intubation for > 48 hours	0.4 0%	3.0 0.3%
Post-pericardiotomy syndrome	0.0 0%	0.2 0%

60. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description	Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame	Early (0-30 days)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Definite	3 0.3%	0 0%
Probable	4 0.4%	0 0%

61. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description	Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame	Acute (<= 24 hours)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Definite	1 0.1%	0 0%
Probable	0 0%	0 0%

62. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Description	Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame	Subacute (1-30 days)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Definite	2 0.2%	0 0%
Probable	4 0.4%	0 0%

63. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description	Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame	Late (>30 days - 1 year)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Definite	0 0%	0 0%
Probable	1 0.1%	0 0%

64. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Description	Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame	Very late (>1 year)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Definite	3 0.3%	0 0%
Probable	1 0.1%	0 0%

65. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	In-hospital (≤ 7 days of index-procedure)

Outcome Measure Data

Analysis Population Description

ITT population. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	0 0%	11 1.1%

66. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	11 1.1%

67. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 6 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	25 2.6%

68. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	33 3.4%

69. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	43 4.5%

70. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	48 5%

71. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 4 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	53 5.5%

72. Secondary Outcome

Title	Number of Participants With Graft Stenosis or Occlusion
Description	Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	0 0%	58 6.1%

73. Secondary Outcome

Title	Number of Participants With Requirement for Blood Product Transfusion
Description	All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	30 3.2%	120 12.5%

74. Secondary Outcome

Title	Number of Participants With Requirement for Blood Product Transfusion
Description	All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	48 5.1%	129 13.5%

75. Secondary Outcome

Title	Number of Participants With Requirement for Blood Product Transfusion
Description	All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	52 5.5%	130 13.6%

76. Secondary Outcome

Title	Number of Participants With Requirement for Blood Product Transfusion
Description	All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	52 5.5%	131 13.7%

77. Secondary Outcome

Title	Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description	Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	35 3.7%	85 8.9%

78. Secondary Outcome

Title	Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description	Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	114 12%	132 13.8%

79. Secondary Outcome

Title	Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description	Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	119 12.6%	133 13.9%

80. Secondary Outcome

Title	Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description	Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

ITT population. Analysis population includes subjects who had follow-up data at that time period.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	119 12.6%	137 14.3%

81. Secondary Outcome

Title	Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description	Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	69 7.3%	123 12.9%

82. Secondary Outcome

Title	Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description	Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	109 11.5%	145 15.2%

83. Secondary Outcome

Title	Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description	Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	112 11.8%	147 15.4%

84. Secondary Outcome

Title	Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description	Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	113 11.9%	153 16%

85. Secondary Outcome

Title	Number of Participants With Major Adverse Events (MAE)
Description	death myocardial infarction stroke Transfusion of ≥2 units of blood TIMI major or minor bleeding major arrhythmia unplanned coronary revascularization for ischemia any unplanned surgery or therapeutic radiologic procedure renal failure sternal wound dehiscence infection requiring antibiotics for treatment intubation for > 48 hours post-pericardiotomy syndrome
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT Population.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Death	9 0.9%	10 1%
Myocardial infarction	37 3.9%	59 6.2%
Stroke	6 0.6%	12 1.3%
Transfusion of >= 2 units blood	38 4%	163 17%
TIMI major or minor bleeding	35 3.7%	85 8.9%
Major arrhythmia	20 2.1%	154 16.1%
Unplanned coronary revascularization for ischemia	6 0.6%	13 1.4%
Unplanned surgery/therapeutic radiologic procedure	12 1.3%	39 4.1%
Renal failure	6 0.6%	24 2.5%
Sternal wound dehiscence	0 0%	19 2%
Infection requiring antibiotics for treatment	24 2.5%	133 13.9%
Intubation for > 48 hours	4 0.4%	28 2.9%
Post-pericardiotomy syndrome	0 0%	4 0.4%

86. Secondary Outcome

Title	Number of Participants With Complete Revascularization (Residual = 0)
Description	Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis). -While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.) From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization. Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized). Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.
Time Frame	At Baseline

Outcome Measure Data

Analysis Population Description

Not all PCI patients have Baseline and Post-PCI Syntax score assessment.

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	917	21
Count of Participants [Participants]	259 27.3%	10 1%

87. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	In-hospital (≤ 7 days of post index procedure)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	942	940
Count of Participants [Participants]	1 0.1%	11 1.1%

88. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	3 0.3%	33 3.4%

89. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	5 0.5%	43 4.5%

90. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	7 0.7%	48 5%

91. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	10 1.1%	53 5.5%

92. Secondary Outcome

Title	Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description	- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Percutaneous Coronary Intervention (PCI)	Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Those patients receiving Coronary Artery Bypass Graft (CABG)
Measure Participants	948	957
Count of Participants [Participants]	10 1.1%	58 6.1%

Adverse Events

Time Frame	5 years
Arm/Group Title	Percutaneous Coronary Intervention (PCI)		Coronary Artery Bypass Graft (CABG)
Arm/Group Description	Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS		Those patients receiving Coronary Artery Bypass Graft (CABG)
All Cause Mortality
	Percutaneous Coronary Intervention (PCI)		Coronary Artery Bypass Graft (CABG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	119/948 (12.6%)		89/957 (9.3%)
Serious Adverse Events
	Percutaneous Coronary Intervention (PCI)		Coronary Artery Bypass Graft (CABG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	535/948 (56.4%)		550/957 (57.5%)
Blood and lymphatic system disorders
Anemia	18/948 (1.9%)		9/957 (0.9%)
Bleeding	31/948 (3.3%)		40/957 (4.2%)
Coagulopathy	1/948 (0.1%)		0/957 (0%)
Epistaxis	2/948 (0.2%)		1/957 (0.1%)
Gastrointestinal bleeding	24/948 (2.5%)		10/957 (1%)
Other	12/948 (1.3%)		12/957 (1.3%)
Respiratory tract bleeding	1/948 (0.1%)		1/957 (0.1%)
Retroperitoneal bleeding	2/948 (0.2%)		2/957 (0.2%)
Thrombocytopenia	2/948 (0.2%)		4/957 (0.4%)
Cardiac disorders
Abrupt closure	3/948 (0.3%)		0/957 (0%)
Acute coronary syndrome	21/948 (2.2%)		13/957 (1.4%)
Angina pectoris (includes atypical angina and cardiac chest pain)	100/948 (10.5%)		54/957 (5.6%)
Angina unstable	31/948 (3.3%)		17/957 (1.8%)
Asystole	2/948 (0.2%)		6/957 (0.6%)
Atrial fibrillation	26/948 (2.7%)		36/957 (3.8%)
Atrial flutter	4/948 (0.4%)		8/957 (0.8%)
Bradycardia	6/948 (0.6%)		8/957 (0.8%)
Cardiac : Other	53/948 (5.6%)		36/957 (3.8%)
Cardiac arrest	10/948 (1.1%)		6/957 (0.6%)
Cardiac enzymes increased	5/948 (0.5%)		4/957 (0.4%)
Cardiac functional test abnormal	6/948 (0.6%)		2/957 (0.2%)
Cardiac tamponade	5/948 (0.5%)		4/957 (0.4%)
Cardiac valve disorder/disease	4/948 (0.4%)		4/957 (0.4%)
Cardio-respiratory arrest	4/948 (0.4%)		3/957 (0.3%)
Cardiogenic shock	5/948 (0.5%)		9/957 (0.9%)
Cardiomyopathy	2/948 (0.2%)		2/957 (0.2%)
Conduction disorder (including AV block, BBB)	3/948 (0.3%)		9/957 (0.9%)
Congestive heart failure	31/948 (3.3%)		37/957 (3.9%)
Coronary arteriospasm	0/948 (0%)		1/957 (0.1%)
Coronary artery dissection	8/948 (0.8%)		0/957 (0%)
Coronary artery graft occlusion	1/948 (0.1%)		30/957 (3.1%)
Coronary artery in-stent restenosis	26/948 (2.7%)		2/957 (0.2%)
Coronary artery occlusion	3/948 (0.3%)		6/957 (0.6%)
Coronary artery perforation	1/948 (0.1%)		0/957 (0%)
Coronary artery reocclusion	2/948 (0.2%)		1/957 (0.1%)
Coronary artery stenosis	19/948 (2%)		7/957 (0.7%)
Coronary stent thrombosis	7/948 (0.7%)		1/957 (0.1%)
Hypertension	3/948 (0.3%)		2/957 (0.2%)
Hypertensive crisis	3/948 (0.3%)		2/957 (0.2%)
Hypotension	9/948 (0.9%)		3/957 (0.3%)
Myocardial infarction	73/948 (7.7%)		47/957 (4.9%)
No-reflow phenomenon/slow flow	1/948 (0.1%)		0/957 (0%)
Palpitations	0/948 (0%)		5/957 (0.5%)
Pericardial effusion	2/948 (0.2%)		4/957 (0.4%)
Plaque shift (tissue breakdown associated with device)	1/948 (0.1%)		0/957 (0%)
Sick sinus syndrome	0/948 (0%)		1/957 (0.1%)
Tachycardia	3/948 (0.3%)		0/957 (0%)
Ventricular fibrillation	7/948 (0.7%)		4/957 (0.4%)
Ventricular tachycardia (sustained)	1/948 (0.1%)		7/957 (0.7%)
electrocardiogram (ECG) abnormal	3/948 (0.3%)		1/957 (0.1%)
Endocrine disorders
Diabetes mellitus	5/948 (0.5%)		2/957 (0.2%)
Hyperthyroidism	0/948 (0%)		1/957 (0.1%)
Hypothyroidism	0/948 (0%)		1/957 (0.1%)
Other : Endocrine disorder	4/948 (0.4%)		4/957 (0.4%)
Gastrointestinal disorders
Abdominal discomfort	1/948 (0.1%)		3/957 (0.3%)
Abdominal pain	2/948 (0.2%)		5/957 (0.5%)
Colonic/intestinal polyp	3/948 (0.3%)		0/957 (0%)
Constipation	0/948 (0%)		1/957 (0.1%)
Diarrhoea	5/948 (0.5%)		6/957 (0.6%)
Dysphagia	2/948 (0.2%)		1/957 (0.1%)
Gastritis	0/948 (0%)		3/957 (0.3%)
Gastroenteritis	3/948 (0.3%)		1/957 (0.1%)
Gastroesophageal reflux diseases	1/948 (0.1%)		2/957 (0.2%)
Gastrointestinal ulcer/peptic ulcer	6/948 (0.6%)		3/957 (0.3%)
Hepatobiliary disease	8/948 (0.8%)		8/957 (0.8%)
Intestinal obstruction	3/948 (0.3%)		5/957 (0.5%)
Nausea	0/948 (0%)		2/957 (0.2%)
Other : Gastrointestinal disorder	27/948 (2.8%)		29/957 (3%)
Pancreatic disorder	2/948 (0.2%)		4/957 (0.4%)
Vomiting	4/948 (0.4%)		5/957 (0.5%)
General disorders
Accidents	0/948 (0%)		1/957 (0.1%)
Cataract	1/948 (0.1%)		1/957 (0.1%)
Chest pain (non-cardiac or non-specific)	10/948 (1.1%)		4/957 (0.4%)
Dehydration	3/948 (0.3%)		2/957 (0.2%)
Edema peripheral	1/948 (0.1%)		1/957 (0.1%)
Eye disorders	1/948 (0.1%)		1/957 (0.1%)
Fall	4/948 (0.4%)		0/957 (0%)
Fatigue/Weakness	2/948 (0.2%)		3/957 (0.3%)
Fever/Pyrexia	1/948 (0.1%)		2/957 (0.2%)
Headache	0/948 (0%)		1/957 (0.1%)
Injury	1/948 (0.1%)		1/957 (0.1%)
Other	11/948 (1.2%)		15/957 (1.6%)
Other shock	0/948 (0%)		1/957 (0.1%)
Pain	1/948 (0.1%)		0/957 (0%)
Immune system disorders
Allergic conditions : Other	0/948 (0%)		1/957 (0.1%)
Contrast media allergy/reaction	1/948 (0.1%)		0/957 (0%)
Drug hypersensitivity/drug allergy	0/948 (0%)		1/957 (0.1%)
Hypersensitivity/allergic reaction	1/948 (0.1%)		3/957 (0.3%)
Infections and infestations
Bone and joint infections	5/948 (0.5%)		6/957 (0.6%)
Cellulitis	6/948 (0.6%)		5/957 (0.5%)
Deep sternal wound infection	1/948 (0.1%)		14/957 (1.5%)
Flu/influenza	3/948 (0.3%)		0/957 (0%)
Gastrointestinal infection	4/948 (0.4%)		4/957 (0.4%)
Genitourinary infection	8/948 (0.8%)		11/957 (1.1%)
Lower respiratory tract infection	7/948 (0.7%)		16/957 (1.7%)
Other : Infection	25/948 (2.6%)		26/957 (2.7%)
Skin and subcutaneous infection	6/948 (0.6%)		11/957 (1.1%)
Upper respiratory tract infection	3/948 (0.3%)		2/957 (0.2%)
Vein harvest site infection	1/948 (0.1%)		6/957 (0.6%)
Injury, poisoning and procedural complications
Catheter site hematoma	2/948 (0.2%)		0/957 (0%)
Other : Percutaneous coronary intervention (PCI) complications	4/948 (0.4%)		2/957 (0.2%)
Investigations
Blood creatinine increased	3/948 (0.3%)		3/957 (0.3%)
Elevated cardiac enzymes	8/948 (0.8%)		3/957 (0.3%)
Hemoglobin decreased	7/948 (0.7%)		2/957 (0.2%)
Hyperglycaemia	3/948 (0.3%)		2/957 (0.2%)
Hyperkalemia	4/948 (0.4%)		2/957 (0.2%)
Hypoglycemia	1/948 (0.1%)		0/957 (0%)
Hypokalemia	1/948 (0.1%)		1/957 (0.1%)
Liver function test abnormal	0/948 (0%)		1/957 (0.1%)
Other	2/948 (0.2%)		5/957 (0.5%)
Other abnormal blood test	0/948 (0%)		1/957 (0.1%)
Musculoskeletal and connective tissue disorders
Arthritis	4/948 (0.4%)		4/957 (0.4%)
Backpain	3/948 (0.3%)		2/957 (0.2%)
Fracture	10/948 (1.1%)		21/957 (2.2%)
Joint or tendon disease/disorder	6/948 (0.6%)		8/957 (0.8%)
Musculoskeletal pain	3/948 (0.3%)		16/957 (1.7%)
Myalgia	0/948 (0%)		1/957 (0.1%)
Other : Musculoskeletal disorder	10/948 (1.1%)		12/957 (1.3%)
Spinal disorder	5/948 (0.5%)		2/957 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm/cancer : Blood or lymphatic	4/948 (0.4%)		3/957 (0.3%)
Neoplasm/cancer : Gastrointestinal	13/948 (1.4%)		4/957 (0.4%)
Neoplasm/cancer : Musculoskeletal	1/948 (0.1%)		2/957 (0.2%)
Neoplasm/cancer : Nervous system	2/948 (0.2%)		1/957 (0.1%)
Neoplasm/cancer : Reproductive system	1/948 (0.1%)		2/957 (0.2%)
Neoplasm/cancer : Respiratory	13/948 (1.4%)		6/957 (0.6%)
Neoplasm/cancer : Skin or subcutaneous	2/948 (0.2%)		4/957 (0.4%)
Neoplasm/cancer : Urinary	7/948 (0.7%)		7/957 (0.7%)
Other :Neoplasm/cancer	13/948 (1.4%)		14/957 (1.5%)
Nervous system disorders
Cerebrovascular accident (CVA)	27/948 (2.8%)		36/957 (3.8%)
Dizziness	4/948 (0.4%)		2/957 (0.2%)
Encephalopathy	1/948 (0.1%)		1/957 (0.1%)
Other : Neurological/psychiatric disorders	9/948 (0.9%)		13/957 (1.4%)
Seizure/convulsion	3/948 (0.3%)		3/957 (0.3%)
Syncope/fainting/loss of consciousness	2/948 (0.2%)		2/957 (0.2%)
Transient ischemic attack (TIA)	6/948 (0.6%)		11/957 (1.1%)
Vertigo	0/948 (0%)		1/957 (0.1%)
Psychiatric disorders
Agitation	0/948 (0%)		1/957 (0.1%)
Anxiety	1/948 (0.1%)		1/957 (0.1%)
Confusion	1/948 (0.1%)		1/957 (0.1%)
Depression	1/948 (0.1%)		1/957 (0.1%)
Mental status change	1/948 (0.1%)		0/957 (0%)
Psychiatric disorder	2/948 (0.2%)		1/957 (0.1%)
Renal and urinary disorders
Benign prostatic hyperplasia	4/948 (0.4%)		3/957 (0.3%)
Incontinence	0/948 (0%)		1/957 (0.1%)
Nephrolithiasis	0/948 (0%)		3/957 (0.3%)
Other : Renal and urinary disorder	14/948 (1.5%)		10/957 (1%)
Renal artery stenosis	0/948 (0%)		3/957 (0.3%)
Renal failure	17/948 (1.8%)		14/957 (1.5%)
Renal insufficiency/impairment	7/948 (0.7%)		17/957 (1.8%)
Urinary retention	1/948 (0.1%)		3/957 (0.3%)
Urinary stone/calculus	2/948 (0.2%)		4/957 (0.4%)
Urinary tract obstruction	2/948 (0.2%)		0/957 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	2/948 (0.2%)		0/957 (0%)
COPD (chronic obstructive pulmonary disease)	12/948 (1.3%)		5/957 (0.5%)
Cough	1/948 (0.1%)		0/957 (0%)
Dyspnea/shortness of breath	13/948 (1.4%)		14/957 (1.5%)
Other : Respiratory disorder	19/948 (2%)		30/957 (3.1%)
Pleural effusion	5/948 (0.5%)		12/957 (1.3%)
Pneumonitis	12/948 (1.3%)		11/957 (1.1%)
Pulmonary embolism	5/948 (0.5%)		5/957 (0.5%)
Respiratory failure	13/948 (1.4%)		27/957 (2.8%)
Vascular disorders
Aneurysm	2/948 (0.2%)		2/957 (0.2%)
Claudication	8/948 (0.8%)		6/957 (0.6%)
Deep vein thrombosis	3/948 (0.3%)		4/957 (0.4%)
Dissection	3/948 (0.3%)		4/957 (0.4%)
Embolism	0/948 (0%)		1/957 (0.1%)
Other : Peripheral vascular disorder	4/948 (0.4%)		5/957 (0.5%)
Peripheral artery disease/peripheral venous disease	13/948 (1.4%)		19/957 (2%)
Peripheral nerve lesion/injury (including peripheral neuropathy)	0/948 (0%)		1/957 (0.1%)
Pseudoaneurysm	2/948 (0.2%)		3/957 (0.3%)
Stenosis	6/948 (0.6%)		10/957 (1%)
Thrombosis (non stent/non-coronary)	2/948 (0.2%)		3/957 (0.3%)
Vascular occlusion	4/948 (0.4%)		6/957 (0.6%)
Other (Not Including Serious) Adverse Events
	Percutaneous Coronary Intervention (PCI)		Coronary Artery Bypass Graft (CABG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	791/948 (83.4%)		831/957 (86.8%)
Blood and lymphatic system disorders
Anemia	42/948 (4.4%)		83/957 (8.7%)
Bleeding	75/948 (7.9%)		121/957 (12.6%)
Coagulopathy	1/948 (0.1%)		2/957 (0.2%)
Epistaxis	10/948 (1.1%)		7/957 (0.7%)
Gastrointestinal bleeding	36/948 (3.8%)		15/957 (1.6%)
Leukocytosis	1/948 (0.1%)		1/957 (0.1%)
Other	47/948 (5%)		33/957 (3.4%)
Respiratory tract bleeding	2/948 (0.2%)		1/957 (0.1%)
Retroperitoneal bleeding	2/948 (0.2%)		3/957 (0.3%)
Thrombocytopenia	2/948 (0.2%)		16/957 (1.7%)
Cardiac disorders
Abrupt closure	3/948 (0.3%)		0/957 (0%)
Acute coronary syndrome	21/948 (2.2%)		14/957 (1.5%)
Angina pectoris (includes atypical angina and cardiac chest pain)	205/948 (21.6%)		124/957 (13%)
Angina unstable	42/948 (4.4%)		22/957 (2.3%)
Asystole	2/948 (0.2%)		7/957 (0.7%)
Atrial fibrillation	54/948 (5.7%)		201/957 (21%)
Atrial flutter	7/948 (0.7%)		17/957 (1.8%)
Bradycardia	24/948 (2.5%)		25/957 (2.6%)
Cardiac arrest	10/948 (1.1%)		7/957 (0.7%)
Cardiac enzymes increased	16/948 (1.7%)		18/957 (1.9%)
Cardiac functional test abnormal	6/948 (0.6%)		2/957 (0.2%)
Cardiac tamponade	5/948 (0.5%)		4/957 (0.4%)
Cardiac valve disorder/disease	4/948 (0.4%)		6/957 (0.6%)
Cardio-respiratory arrest	4/948 (0.4%)		3/957 (0.3%)
Cardiogenic shock	5/948 (0.5%)		10/957 (1%)
Cardiomyopathy	4/948 (0.4%)		6/957 (0.6%)
Conduction disorder (including atrioventricular block (AV block, bundle branch block(BBB))	6/948 (0.6%)		16/957 (1.7%)
Congestive heart failure	39/948 (4.1%)		50/957 (5.2%)
Coronary arteriospasm	0/948 (0%)		2/957 (0.2%)
Coronary artery dissection	23/948 (2.4%)		1/957 (0.1%)
Coronary artery embolism	0/948 (0%)		0/957 (0%)
Coronary artery graft occlusion	1/948 (0.1%)		34/957 (3.6%)
Coronary artery in-stent restenosis	27/948 (2.8%)		3/957 (0.3%)
Coronary artery occlusion	7/948 (0.7%)		6/957 (0.6%)
Coronary artery perforation	3/948 (0.3%)		1/957 (0.1%)
Coronary artery reocclusion	2/948 (0.2%)		1/957 (0.1%)
Coronary artery stenosis	20/948 (2.1%)		8/957 (0.8%)
Coronary stent thrombosis	7/948 (0.7%)		2/957 (0.2%)
Electrocardiogram (ECG) abnormal	10/948 (1.1%)		14/957 (1.5%)
Hypertension	31/948 (3.3%)		42/957 (4.4%)
Hypertensive crisis	4/948 (0.4%)		4/957 (0.4%)
Hypotension	32/948 (3.4%)		23/957 (2.4%)
Myocardial infarction	78/948 (8.2%)		58/957 (6.1%)
No-reflow phenomenon/slow flow	9/948 (0.9%)		0/957 (0%)
Other	103/948 (10.9%)		85/957 (8.9%)
Palpitations	12/948 (1.3%)		16/957 (1.7%)
Pericardial effusion	4/948 (0.4%)		11/957 (1.1%)
Plaque shift (tissue breakdown associated with device)	1/948 (0.1%)		0/957 (0%)
Sick sinus syndrome	0/948 (0%)		2/957 (0.2%)
Tachycardia	12/948 (1.3%)		18/957 (1.9%)
Ventricular fibrillation	7/948 (0.7%)		5/957 (0.5%)
Ventricular tachycardia (sustained)	4/948 (0.4%)		8/957 (0.8%)
Endocrine disorders
Diabetes mellitus	21/948 (2.2%)		19/957 (2%)
Hyperthyroidism	0/948 (0%)		3/957 (0.3%)
Hypothyroidism	6/948 (0.6%)		5/957 (0.5%)
Other	9/948 (0.9%)		18/957 (1.9%)
Gastrointestinal disorders
Abdominal discomfort	5/948 (0.5%)		5/957 (0.5%)
Abdominal pain	16/948 (1.7%)		14/957 (1.5%)
Colonic/intestinal polyp	12/948 (1.3%)		5/957 (0.5%)
Constipation	9/948 (0.9%)		13/957 (1.4%)
Diarrhoea	18/948 (1.9%)		19/957 (2%)
Dyspepsia	4/948 (0.4%)		1/957 (0.1%)
Dysphagia	7/948 (0.7%)		2/957 (0.2%)
Gastritis	4/948 (0.4%)		11/957 (1.1%)
Gastroenteritis	5/948 (0.5%)		5/957 (0.5%)
Gastrointestinal ulcer/peptic ulcer	8/948 (0.8%)		3/957 (0.3%)
Gastrooesophageal reflux diseases	12/948 (1.3%)		12/957 (1.3%)
Hepatobiliary disease	11/948 (1.2%)		13/957 (1.4%)
Intestinal obstruction	4/948 (0.4%)		5/957 (0.5%)
Nausea	7/948 (0.7%)		20/957 (2.1%)
Other	69/948 (7.3%)		61/957 (6.4%)
Pancreatic disorder	3/948 (0.3%)		4/957 (0.4%)
Vomiting	12/948 (1.3%)		17/957 (1.8%)
General disorders
Accidents	0/948 (0%)		2/957 (0.2%)
Cataract	4/948 (0.4%)		8/957 (0.8%)
Chest pain (non-cardiac or non-specific)	30/948 (3.2%)		26/957 (2.7%)
Dehydration	3/948 (0.3%)		4/957 (0.4%)
Ear disorders	3/948 (0.3%)		2/957 (0.2%)
Ecchymosis	4/948 (0.4%)		1/957 (0.1%)
Edema peripheral	15/948 (1.6%)		17/957 (1.8%)
Eye disorders	3/948 (0.3%)		9/957 (0.9%)
Fall	10/948 (1.1%)		2/957 (0.2%)
Fatigue/Weakness	20/948 (2.1%)		25/957 (2.6%)
Fever/Pyrexia	4/948 (0.4%)		6/957 (0.6%)
Headache	6/948 (0.6%)		3/957 (0.3%)
Injury	4/948 (0.4%)		4/957 (0.4%)
Other	53/948 (5.6%)		56/957 (5.9%)
Other shock	0/948 (0%)		1/957 (0.1%)
Pain	6/948 (0.6%)		8/957 (0.8%)
Pruritis	0/948 (0%)		1/957 (0.1%)
Rash	5/948 (0.5%)		6/957 (0.6%)
Immune system disorders
Allergy to metal	0/948 (0%)		1/957 (0.1%)
Contrast media allergy/reaction	4/948 (0.4%)		0/957 (0%)
Drug hypersensitivity/drug allergy	19/948 (2%)		11/957 (1.1%)
Hypersensitivity/allergic reaction	11/948 (1.2%)		5/957 (0.5%)
Other	8/948 (0.8%)		7/957 (0.7%)
Infections and infestations
Bone and joint infections	7/948 (0.7%)		6/957 (0.6%)
Cellulitis	12/948 (1.3%)		11/957 (1.1%)
Deep sternal wound infection	1/948 (0.1%)		18/957 (1.9%)
Flu/influenza	5/948 (0.5%)		2/957 (0.2%)
Gastrointestinal infection	6/948 (0.6%)		9/957 (0.9%)
Genitourinary infection	25/948 (2.6%)		43/957 (4.5%)
Joint infection	0/948 (0%)		0/957 (0%)
Lower respiratory tract infection	28/948 (3%)		57/957 (6%)
Other	43/948 (4.5%)		61/957 (6.4%)
Skin and subcutaneous infection	14/948 (1.5%)		34/957 (3.6%)
Upper respiratory tract infection	26/948 (2.7%)		25/957 (2.6%)
Vein harvest site infection	1/948 (0.1%)		19/957 (2%)
Injury, poisoning and procedural complications
Catheter site hematoma	24/948 (2.5%)		1/957 (0.1%)
Catheter site pain	3/948 (0.3%)		0/957 (0%)
Catheter site swelling	1/948 (0.1%)		0/957 (0%)
Cathether site bleeding	4/948 (0.4%)		0/957 (0%)
Other	12/948 (1.3%)		2/957 (0.2%)
Investigations
Blood creatinine increased	12/948 (1.3%)		11/957 (1.1%)
Blood creatinine phosphokinase increased	0/948 (0%)		1/957 (0.1%)
Elevated cardiac enzymes	44/948 (4.6%)		88/957 (9.2%)
Hematocrit decreased	1/948 (0.1%)		5/957 (0.5%)
Hemoglobin decreased	17/948 (1.8%)		35/957 (3.7%)
Hyperglycaemia	3/948 (0.3%)		16/957 (1.7%)
Hyperkalaemia	7/948 (0.7%)		9/957 (0.9%)
Hyperlipidaemia/hypercholesterolemia	5/948 (0.5%)		4/957 (0.4%)
Hypoglycemia	1/948 (0.1%)		2/957 (0.2%)
Hypokalaemia	9/948 (0.9%)		11/957 (1.1%)
Liver function test abnormal	8/948 (0.8%)		14/957 (1.5%)
Other	14/948 (1.5%)		37/957 (3.9%)
Other abnormal blood test	4/948 (0.4%)		16/957 (1.7%)
Musculoskeletal and connective tissue disorders
Arthritis	20/948 (2.1%)		16/957 (1.7%)
Backpain	24/948 (2.5%)		23/957 (2.4%)
Fracture	22/948 (2.3%)		30/957 (3.1%)
Joint or tendon disease/disorder	21/948 (2.2%)		19/957 (2%)
Muscle spasms	7/948 (0.7%)		5/957 (0.5%)
Musculoskeletal pain	49/948 (5.2%)		60/957 (6.3%)
Myalgia	18/948 (1.9%)		6/957 (0.6%)
Other	69/948 (7.3%)		69/957 (7.2%)
Spinal disorder	9/948 (0.9%)		8/957 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm/cancer : Blood or lymphatic	5/948 (0.5%)		3/957 (0.3%)
Neoplasm/cancer : Gastrointestinal	13/948 (1.4%)		5/957 (0.5%)
Neoplasm/cancer : Musculoskeletal	1/948 (0.1%)		2/957 (0.2%)
Neoplasm/cancer : Nervous system	2/948 (0.2%)		1/957 (0.1%)
Neoplasm/cancer : Other	19/948 (2%)		16/957 (1.7%)
Neoplasm/cancer : Reproductive system	2/948 (0.2%)		3/957 (0.3%)
Neoplasm/cancer : Respiratory	13/948 (1.4%)		6/957 (0.6%)
Neoplasm/cancer : Skin or subcutaneous	13/948 (1.4%)		11/957 (1.1%)
Neoplasm/cancer : Urinary	8/948 (0.8%)		10/957 (1%)
Nervous system disorders
Cerebrovascular accident (CVA)	29/948 (3.1%)		36/957 (3.8%)
Dizziness	11/948 (1.2%)		9/957 (0.9%)
Encephalopathy	5/948 (0.5%)		1/957 (0.1%)
Headache	1/948 (0.1%)		3/957 (0.3%)
Other : Neurological/psychiatric disorders	28/948 (3%)		51/957 (5.3%)
Seizure/convulsion	3/948 (0.3%)		6/957 (0.6%)
Sleep disorder	0/948 (0%)		3/957 (0.3%)
Syncope/fainting/loss of consciousness	9/948 (0.9%)		6/957 (0.6%)
Transient ischemic attack (TIA)	10/948 (1.1%)		18/957 (1.9%)
Vertigo	3/948 (0.3%)		4/957 (0.4%)
Psychiatric disorders
Agitation	1/948 (0.1%)		6/957 (0.6%)
Anxiety	5/948 (0.5%)		8/957 (0.8%)
Confusion	4/948 (0.4%)		7/957 (0.7%)
Dementia	1/948 (0.1%)		3/957 (0.3%)
Depression	9/948 (0.9%)		9/957 (0.9%)
Mental status change (including coma)	3/948 (0.3%)		1/957 (0.1%)
Psychiatric disorder	2/948 (0.2%)		2/957 (0.2%)
Renal and urinary disorders
Benign prostatic hyperplasia	10/948 (1.1%)		7/957 (0.7%)
Incontinence	1/948 (0.1%)		2/957 (0.2%)
Nephrolithiasis	3/948 (0.3%)		3/957 (0.3%)
Other	32/948 (3.4%)		40/957 (4.2%)
Renal artery stenosis	1/948 (0.1%)		3/957 (0.3%)
Renal failure	21/948 (2.2%)		24/957 (2.5%)
Renal insufficiency/impairment	20/948 (2.1%)		28/957 (2.9%)
Urinary retention	8/948 (0.8%)		6/957 (0.6%)
Urinary stone/calculus	6/948 (0.6%)		9/957 (0.9%)
Urinary tract obstruction	2/948 (0.2%)		1/957 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	4/948 (0.4%)		4/957 (0.4%)
COPD (chronic obstructive pulmonary disease)	23/948 (2.4%)		19/957 (2%)
Cough	8/948 (0.8%)		21/957 (2.2%)
Dyspnea/shortness of breath	58/948 (6.1%)		57/957 (6%)
Other	51/948 (5.4%)		101/957 (10.6%)
Pleural effusion	11/948 (1.2%)		63/957 (6.6%)
Pneumonitis	18/948 (1.9%)		14/957 (1.5%)
Pulmonary embolism	7/948 (0.7%)		6/957 (0.6%)
Pulmonary hypertension	1/948 (0.1%)		0/957 (0%)
Respiratory failure	15/948 (1.6%)		38/957 (4%)
Vascular disorders
Aneurysm	4/948 (0.4%)		6/957 (0.6%)
Arteriovenous fistula	0/948 (0%)		1/957 (0.1%)
Claudication	12/948 (1.3%)		16/957 (1.7%)
Deep vein thrombosis	5/948 (0.5%)		7/957 (0.7%)
Embolism	0/948 (0%)		1/957 (0.1%)
Other	14/948 (1.5%)		19/957 (2%)
Peripheral artery disease/peripheral venous disease	26/948 (2.7%)		27/957 (2.8%)
Peripheral nerve lesion/injury	2/948 (0.2%)		2/957 (0.2%)
Pseudoaneurysm	2/948 (0.2%)		4/957 (0.4%)
Stenosis	17/948 (1.8%)		11/957 (1.1%)
Thrombophlebitis	3/948 (0.3%)		4/957 (0.4%)
Thrombosis (non stent/non-coronary)	2/948 (0.2%)		4/957 (0.4%)
Vascular occlusion	4/948 (0.4%)		6/957 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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