Trial Outcomes & Findings for EXCEL Clinical Trial (NCT NCT01205776)

NCT ID: NCT01205776

Last Updated: 2020-04-07

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1905 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2020-04-07

Participant Flow

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.

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.

Participant milestones

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

Reasons for withdrawal

Measure	Percutaneous Coronary Intervention (PCI) Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) Those patients receiving Coronary Artery Bypass Graft (CABG)
Overall Study Lost to Follow-up	53	61
Overall Study Withdrawal by Subject	11	34

Baseline Characteristics

EXCEL Clinical Trial

Baseline characteristics by cohort

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)	Total n=1905 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 9.6 • n=5 Participants	65.9 years STANDARD_DEVIATION 9.5 • n=7 Participants	66.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	722 Participants n=5 Participants	742 Participants n=7 Participants	1464 Participants n=5 Participants
Sex: Female, Male Male	226 Participants n=5 Participants	215 Participants n=7 Participants	441 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	844 Participants n=5 Participants	853 Participants n=7 Participants	1697 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment Europe	534 Participants n=5 Participants	541 Participants n=7 Participants	1075 Participants n=5 Participants
Region of Enrollment United States	278 Participants n=5 Participants	271 Participants n=7 Participants	549 Participants n=5 Participants
Region of Enrollment Canada	103 Participants n=5 Participants	100 Participants n=7 Participants	203 Participants n=5 Participants
Region of Enrollment Southeast Asia	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Australia	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment South America	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	203 Participants	176 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	40 Participants	77 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	46 Participants	75 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	66 Participants	97 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	80 Participants	106 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	115 Participants	122 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	137 Participants	135 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	173 Participants	154 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	203 Participants	176 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	40 Participants	82 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

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

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	46 Participants	80 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	79 Participants	112 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	121 Participants	129 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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).

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	177 Participants	154 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	213 Participants	176 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	260 Participants	203 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia	290 Participants	228 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	4 Participants	12 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	19 Participants	23 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	31 Participants	33 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	54 Participants	44 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	74 Participants	54 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	95 Participants	68 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)	119 Participants	89 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	34 Participants	58 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	37 Participants	59 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	46 Participants	68 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	53 Participants	68 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	64 Participants	73 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	74 Participants	78 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	86 Participants	81 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Protocol Defined MI	95 Participants	84 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	4 Participants	13 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	9 Participants	16 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	10 Participants	18 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	17 Participants	22 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	21 Participants	28 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	23 Participants	30 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)	26 Participants	33 Participants

SECONDARY outcome

Timeframe: 90 days ± 2 weeks

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=17 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=29 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Disability Following Stroke Event	6 Participants	9 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)	3 Participants	12 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	6 Participants	13 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	28 Participants	29 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	62 Participants	40 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	95 Participants	56 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	114 Participants	67 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	143 Participants	81 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Ischemia Driven Revascularizations	150 Participants	88 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)	3 Participants	12 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	7 Participants	13 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	29 Participants	30 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	63 Participants	42 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	97 Participants	57 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	116 Participants	68 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	146 Participants	83 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

• 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)	153 Participants	92 Participants

SECONDARY outcome

Timeframe: In-hospital

Population: ITT Population.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: Early (0-30 days)

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Definite	3 Participants	0 Participants
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Probable	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Acute (<= 24 hours)

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Definite	1 Participants	0 Participants
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Subacute (1-30 days)

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable Definite	2 Participants	0 Participants
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable Probable	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Late (>30 days - 1 year)

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Definite	0 Participants	0 Participants
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable Probable	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Very late (>1 year)

Population: ITT population.

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable Probable	1 Participants	0 Participants
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable Definite	3 Participants	0 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of index-procedure)

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

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	11 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	11 Participants

SECONDARY outcome

Timeframe: 0 to 6 months

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	25 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	33 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	43 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	48 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	53 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Graft Stenosis or Occlusion	0 Participants	58 Participants

SECONDARY outcome

Timeframe: 30 days

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

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].

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Requirement for Blood Product Transfusion	30 Participants	120 Participants

SECONDARY outcome

Timeframe: 3 years

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

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].

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Requirement for Blood Product Transfusion	48 Participants	129 Participants

SECONDARY outcome

Timeframe: 4 years

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

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].

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Requirement for Blood Product Transfusion	52 Participants	130 Participants

SECONDARY outcome

Timeframe: 5 years

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

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].

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Requirement for Blood Product Transfusion	52 Participants	131 Participants

SECONDARY outcome

Timeframe: 30 days

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding	35 Participants	85 Participants

SECONDARY outcome

Timeframe: 3 years

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding	114 Participants	132 Participants

SECONDARY outcome

Timeframe: 4 years

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding	119 Participants	133 Participants

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding	119 Participants	137 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT Population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding	69 Participants	123 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT Population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding	109 Participants	145 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT Population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding	112 Participants	147 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT Population.

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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding	113 Participants	153 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT Population.

• 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

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Major Adverse Events (MAE) Renal failure	6 Participants	24 Participants
Number of Participants With Major Adverse Events (MAE) Death	9 Participants	10 Participants
Number of Participants With Major Adverse Events (MAE) Myocardial infarction	37 Participants	59 Participants
Number of Participants With Major Adverse Events (MAE) Stroke	6 Participants	12 Participants
Number of Participants With Major Adverse Events (MAE) Transfusion of >= 2 units blood	38 Participants	163 Participants
Number of Participants With Major Adverse Events (MAE) TIMI major or minor bleeding	35 Participants	85 Participants
Number of Participants With Major Adverse Events (MAE) Major arrhythmia	20 Participants	154 Participants
Number of Participants With Major Adverse Events (MAE) Unplanned coronary revascularization for ischemia	6 Participants	13 Participants
Number of Participants With Major Adverse Events (MAE) Unplanned surgery/therapeutic radiologic procedure	12 Participants	39 Participants
Number of Participants With Major Adverse Events (MAE) Sternal wound dehiscence	0 Participants	19 Participants
Number of Participants With Major Adverse Events (MAE) Infection requiring antibiotics for treatment	24 Participants	133 Participants
Number of Participants With Major Adverse Events (MAE) Intubation for > 48 hours	4 Participants	28 Participants
Number of Participants With Major Adverse Events (MAE) Post-pericardiotomy syndrome	0 Participants	4 Participants

SECONDARY outcome

Timeframe: At Baseline

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

1. 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.)

2. 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.

3. 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).

4. Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=917 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=21 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Complete Revascularization (Residual = 0)	259 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=942 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=940 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion	1 Participants	11 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion	3 Participants	33 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion	5 Participants	43 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion	7 Participants	48 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion	10 Participants	53 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Percutaneous Coronary Intervention (PCI) n=948 Participants Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 Participants Those patients receiving Coronary Artery Bypass Graft (CABG)
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion	10 Participants	58 Participants

Adverse Events

Percutaneous Coronary Intervention (PCI)

Serious events: 535 serious events

Other events: 791 other events

Deaths: 119 deaths

Coronary Artery Bypass Graft (CABG)

Serious events: 550 serious events

Other events: 831 other events

Deaths: 89 deaths

Serious adverse events

Measure	Percutaneous Coronary Intervention (PCI) n=948 participants at risk Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 participants at risk Those patients receiving Coronary Artery Bypass Graft (CABG)
Psychiatric disorders Agitation	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Psychiatric disorders Anxiety	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Blood and lymphatic system disorders Anemia	1.9% 18/948 • 5 years	0.94% 9/957 • 5 years
Blood and lymphatic system disorders Bleeding	3.3% 31/948 • 5 years	4.2% 40/957 • 5 years
Blood and lymphatic system disorders Coagulopathy	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Blood and lymphatic system disorders Epistaxis	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Blood and lymphatic system disorders Gastrointestinal bleeding	2.5% 24/948 • 5 years	1.0% 10/957 • 5 years
Blood and lymphatic system disorders Other	1.3% 12/948 • 5 years	1.3% 12/957 • 5 years
Blood and lymphatic system disorders Respiratory tract bleeding	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Blood and lymphatic system disorders Retroperitoneal bleeding	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Abrupt closure	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Acute coronary syndrome	2.2% 21/948 • 5 years	1.4% 13/957 • 5 years
Cardiac disorders Angina pectoris (includes atypical angina and cardiac chest pain)	10.5% 100/948 • 5 years	5.6% 54/957 • 5 years
Cardiac disorders Angina unstable	3.3% 31/948 • 5 years	1.8% 17/957 • 5 years
Cardiac disorders Asystole	0.21% 2/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Atrial fibrillation	2.7% 26/948 • 5 years	3.8% 36/957 • 5 years
Cardiac disorders Atrial flutter	0.42% 4/948 • 5 years	0.84% 8/957 • 5 years
Cardiac disorders Bradycardia	0.63% 6/948 • 5 years	0.84% 8/957 • 5 years
Cardiac disorders Cardiac : Other	5.6% 53/948 • 5 years	3.8% 36/957 • 5 years
Cardiac disorders Cardiac arrest	1.1% 10/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Cardiac enzymes increased	0.53% 5/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Cardiac functional test abnormal	0.63% 6/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Cardiac tamponade	0.53% 5/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Cardiac valve disorder/disease	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Cardio-respiratory arrest	0.42% 4/948 • 5 years	0.31% 3/957 • 5 years
Cardiac disorders Cardiogenic shock	0.53% 5/948 • 5 years	0.94% 9/957 • 5 years
Cardiac disorders Cardiomyopathy	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Conduction disorder (including AV block, BBB)	0.32% 3/948 • 5 years	0.94% 9/957 • 5 years
Cardiac disorders Congestive heart failure	3.3% 31/948 • 5 years	3.9% 37/957 • 5 years
Cardiac disorders Coronary arteriospasm	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Coronary artery dissection	0.84% 8/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Coronary artery graft occlusion	0.11% 1/948 • 5 years	3.1% 30/957 • 5 years
Cardiac disorders Coronary artery in-stent restenosis	2.7% 26/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Coronary artery occlusion	0.32% 3/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Coronary artery perforation	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Coronary artery reocclusion	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Coronary artery stenosis	2.0% 19/948 • 5 years	0.73% 7/957 • 5 years
Cardiac disorders Coronary stent thrombosis	0.74% 7/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Hypertension	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Hypertensive crisis	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Hypotension	0.95% 9/948 • 5 years	0.31% 3/957 • 5 years
Cardiac disorders Myocardial infarction	7.7% 73/948 • 5 years	4.9% 47/957 • 5 years
Cardiac disorders No-reflow phenomenon/slow flow	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Palpitations	0.00% 0/948 • 5 years	0.52% 5/957 • 5 years
Cardiac disorders Pericardial effusion	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Plaque shift (tissue breakdown associated with device)	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Sick sinus syndrome	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Tachycardia	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Ventricular fibrillation	0.74% 7/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Ventricular tachycardia (sustained)	0.11% 1/948 • 5 years	0.73% 7/957 • 5 years
Cardiac disorders electrocardiogram (ECG) abnormal	0.32% 3/948 • 5 years	0.10% 1/957 • 5 years
Endocrine disorders Diabetes mellitus	0.53% 5/948 • 5 years	0.21% 2/957 • 5 years
Endocrine disorders Hyperthyroidism	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Endocrine disorders Hypothyroidism	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Endocrine disorders Other : Endocrine disorder	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Gastrointestinal disorders Abdominal discomfort	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Gastrointestinal disorders Abdominal pain	0.21% 2/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Colonic/intestinal polyp	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Gastrointestinal disorders Constipation	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Gastrointestinal disorders Diarrhoea	0.53% 5/948 • 5 years	0.63% 6/957 • 5 years
Gastrointestinal disorders Dysphagia	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Gastrointestinal disorders Gastritis	0.00% 0/948 • 5 years	0.31% 3/957 • 5 years
Gastrointestinal disorders Gastroenteritis	0.32% 3/948 • 5 years	0.10% 1/957 • 5 years
Gastrointestinal disorders Gastroesophageal reflux diseases	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Gastrointestinal disorders Gastrointestinal ulcer/peptic ulcer	0.63% 6/948 • 5 years	0.31% 3/957 • 5 years
Gastrointestinal disorders Hepatobiliary disease	0.84% 8/948 • 5 years	0.84% 8/957 • 5 years
Gastrointestinal disorders Intestinal obstruction	0.32% 3/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Nausea	0.00% 0/948 • 5 years	0.21% 2/957 • 5 years
Gastrointestinal disorders Other : Gastrointestinal disorder	2.8% 27/948 • 5 years	3.0% 29/957 • 5 years
Gastrointestinal disorders Pancreatic disorder	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Gastrointestinal disorders Vomiting	0.42% 4/948 • 5 years	0.52% 5/957 • 5 years
General disorders Accidents	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
General disorders Cataract	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
General disorders Chest pain (non-cardiac or non-specific)	1.1% 10/948 • 5 years	0.42% 4/957 • 5 years
General disorders Dehydration	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
General disorders Edema peripheral	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
General disorders Eye disorders	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
General disorders Fall	0.42% 4/948 • 5 years	0.00% 0/957 • 5 years
General disorders Fatigue/Weakness	0.21% 2/948 • 5 years	0.31% 3/957 • 5 years
General disorders Fever/Pyrexia	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
General disorders Headache	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
General disorders Injury	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
General disorders Other	1.2% 11/948 • 5 years	1.6% 15/957 • 5 years
General disorders Other shock	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
General disorders Pain	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Immune system disorders Allergic conditions : Other	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Immune system disorders Contrast media allergy/reaction	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Immune system disorders Drug hypersensitivity/drug allergy	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Immune system disorders Hypersensitivity/allergic reaction	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Infections and infestations Bone and joint infections	0.53% 5/948 • 5 years	0.63% 6/957 • 5 years
Infections and infestations Cellulitis	0.63% 6/948 • 5 years	0.52% 5/957 • 5 years
Infections and infestations Deep sternal wound infection	0.11% 1/948 • 5 years	1.5% 14/957 • 5 years
Infections and infestations Flu/influenza	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Infections and infestations Gastrointestinal infection	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Infections and infestations Genitourinary infection	0.84% 8/948 • 5 years	1.1% 11/957 • 5 years
Infections and infestations Lower respiratory tract infection	0.74% 7/948 • 5 years	1.7% 16/957 • 5 years
Infections and infestations Other : Infection	2.6% 25/948 • 5 years	2.7% 26/957 • 5 years
Infections and infestations Skin and subcutaneous infection	0.63% 6/948 • 5 years	1.1% 11/957 • 5 years
Infections and infestations Upper respiratory tract infection	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
Infections and infestations Vein harvest site infection	0.11% 1/948 • 5 years	0.63% 6/957 • 5 years
Injury, poisoning and procedural complications Catheter site hematoma	0.21% 2/948 • 5 years	0.00% 0/957 • 5 years
Injury, poisoning and procedural complications Other : Percutaneous coronary intervention (PCI) complications	0.42% 4/948 • 5 years	0.21% 2/957 • 5 years
Investigations Blood creatinine increased	0.32% 3/948 • 5 years	0.31% 3/957 • 5 years
Investigations Elevated cardiac enzymes	0.84% 8/948 • 5 years	0.31% 3/957 • 5 years
Investigations Hemoglobin decreased	0.74% 7/948 • 5 years	0.21% 2/957 • 5 years
Investigations Hyperglycaemia	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
Investigations Hyperkalemia	0.42% 4/948 • 5 years	0.21% 2/957 • 5 years
Investigations Hypoglycemia	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Investigations Hypokalemia	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Investigations Liver function test abnormal	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Investigations Other	0.21% 2/948 • 5 years	0.52% 5/957 • 5 years
Investigations Other abnormal blood test	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Musculoskeletal and connective tissue disorders Arthritis	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Musculoskeletal and connective tissue disorders Backpain	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
Musculoskeletal and connective tissue disorders Fracture	1.1% 10/948 • 5 years	2.2% 21/957 • 5 years
Musculoskeletal and connective tissue disorders Joint or tendon disease/disorder	0.63% 6/948 • 5 years	0.84% 8/957 • 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.32% 3/948 • 5 years	1.7% 16/957 • 5 years
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Musculoskeletal and connective tissue disorders Other : Musculoskeletal disorder	1.1% 10/948 • 5 years	1.3% 12/957 • 5 years
Musculoskeletal and connective tissue disorders Spinal disorder	0.53% 5/948 • 5 years	0.21% 2/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Blood or lymphatic	0.42% 4/948 • 5 years	0.31% 3/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Gastrointestinal	1.4% 13/948 • 5 years	0.42% 4/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Musculoskeletal	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Nervous system	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Reproductive system	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Respiratory	1.4% 13/948 • 5 years	0.63% 6/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Skin or subcutaneous	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Urinary	0.74% 7/948 • 5 years	0.73% 7/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other :Neoplasm/cancer	1.4% 13/948 • 5 years	1.5% 14/957 • 5 years
Nervous system disorders Cerebrovascular accident (CVA)	2.8% 27/948 • 5 years	3.8% 36/957 • 5 years
Nervous system disorders Dizziness	0.42% 4/948 • 5 years	0.21% 2/957 • 5 years
Nervous system disorders Encephalopathy	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Nervous system disorders Other : Neurological/psychiatric disorders	0.95% 9/948 • 5 years	1.4% 13/957 • 5 years
Nervous system disorders Seizure/convulsion	0.32% 3/948 • 5 years	0.31% 3/957 • 5 years
Nervous system disorders Syncope/fainting/loss of consciousness	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Nervous system disorders Transient ischemic attack (TIA)	0.63% 6/948 • 5 years	1.1% 11/957 • 5 years
Nervous system disorders Vertigo	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Psychiatric disorders Confusion	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Psychiatric disorders Depression	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Psychiatric disorders Mental status change	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Psychiatric disorders Psychiatric disorder	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Renal and urinary disorders Benign prostatic hyperplasia	0.42% 4/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Incontinence	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Renal and urinary disorders Nephrolithiasis	0.00% 0/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Other : Renal and urinary disorder	1.5% 14/948 • 5 years	1.0% 10/957 • 5 years
Renal and urinary disorders Renal artery stenosis	0.00% 0/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Renal failure	1.8% 17/948 • 5 years	1.5% 14/957 • 5 years
Renal and urinary disorders Renal insufficiency/impairment	0.74% 7/948 • 5 years	1.8% 17/957 • 5 years
Renal and urinary disorders Urinary retention	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Urinary stone/calculus	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Renal and urinary disorders Urinary tract obstruction	0.21% 2/948 • 5 years	0.00% 0/957 • 5 years
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 2/948 • 5 years	0.00% 0/957 • 5 years
Respiratory, thoracic and mediastinal disorders COPD (chronic obstructive pulmonary disease)	1.3% 12/948 • 5 years	0.52% 5/957 • 5 years
Respiratory, thoracic and mediastinal disorders Cough	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea/shortness of breath	1.4% 13/948 • 5 years	1.5% 14/957 • 5 years
Respiratory, thoracic and mediastinal disorders Other : Respiratory disorder	2.0% 19/948 • 5 years	3.1% 30/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.53% 5/948 • 5 years	1.3% 12/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.3% 12/948 • 5 years	1.1% 11/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.53% 5/948 • 5 years	0.52% 5/957 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 13/948 • 5 years	2.8% 27/957 • 5 years
Vascular disorders Aneurysm	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Vascular disorders Claudication	0.84% 8/948 • 5 years	0.63% 6/957 • 5 years
Vascular disorders Deep vein thrombosis	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
Vascular disorders Dissection	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
Vascular disorders Embolism	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Vascular disorders Other : Peripheral vascular disorder	0.42% 4/948 • 5 years	0.52% 5/957 • 5 years
Vascular disorders Peripheral artery disease/peripheral venous disease	1.4% 13/948 • 5 years	2.0% 19/957 • 5 years
Vascular disorders Peripheral nerve lesion/injury (including peripheral neuropathy)	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Vascular disorders Pseudoaneurysm	0.21% 2/948 • 5 years	0.31% 3/957 • 5 years
Vascular disorders Stenosis	0.63% 6/948 • 5 years	1.0% 10/957 • 5 years
Vascular disorders Thrombosis (non stent/non-coronary)	0.21% 2/948 • 5 years	0.31% 3/957 • 5 years
Vascular disorders Vascular occlusion	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years

Other adverse events

Measure	Percutaneous Coronary Intervention (PCI) n=948 participants at risk Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Coronary Artery Bypass Graft (CABG) n=957 participants at risk Those patients receiving Coronary Artery Bypass Graft (CABG)
Blood and lymphatic system disorders Anemia	4.4% 42/948 • 5 years	8.7% 83/957 • 5 years
Blood and lymphatic system disorders Bleeding	7.9% 75/948 • 5 years	12.6% 121/957 • 5 years
Blood and lymphatic system disorders Coagulopathy	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Blood and lymphatic system disorders Epistaxis	1.1% 10/948 • 5 years	0.73% 7/957 • 5 years
Blood and lymphatic system disorders Gastrointestinal bleeding	3.8% 36/948 • 5 years	1.6% 15/957 • 5 years
Blood and lymphatic system disorders Leukocytosis	0.11% 1/948 • 5 years	0.10% 1/957 • 5 years
Blood and lymphatic system disorders Other	5.0% 47/948 • 5 years	3.4% 33/957 • 5 years
Blood and lymphatic system disorders Respiratory tract bleeding	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Blood and lymphatic system disorders Retroperitoneal bleeding	0.21% 2/948 • 5 years	0.31% 3/957 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	0.21% 2/948 • 5 years	1.7% 16/957 • 5 years
Cardiac disorders Abrupt closure	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Acute coronary syndrome	2.2% 21/948 • 5 years	1.5% 14/957 • 5 years
Cardiac disorders Angina pectoris (includes atypical angina and cardiac chest pain)	21.6% 205/948 • 5 years	13.0% 124/957 • 5 years
Cardiac disorders Angina unstable	4.4% 42/948 • 5 years	2.3% 22/957 • 5 years
Cardiac disorders Asystole	0.21% 2/948 • 5 years	0.73% 7/957 • 5 years
Cardiac disorders Atrial fibrillation	5.7% 54/948 • 5 years	21.0% 201/957 • 5 years
Cardiac disorders Atrial flutter	0.74% 7/948 • 5 years	1.8% 17/957 • 5 years
Cardiac disorders Bradycardia	2.5% 24/948 • 5 years	2.6% 25/957 • 5 years
Cardiac disorders Cardiac arrest	1.1% 10/948 • 5 years	0.73% 7/957 • 5 years
Cardiac disorders Cardiac enzymes increased	1.7% 16/948 • 5 years	1.9% 18/957 • 5 years
Cardiac disorders Cardiac functional test abnormal	0.63% 6/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Cardiac tamponade	0.53% 5/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Cardiac valve disorder/disease	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Cardio-respiratory arrest	0.42% 4/948 • 5 years	0.31% 3/957 • 5 years
Cardiac disorders Cardiogenic shock	0.53% 5/948 • 5 years	1.0% 10/957 • 5 years
Cardiac disorders Cardiomyopathy	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Conduction disorder (including atrioventricular block (AV block, bundle branch block(BBB))	0.63% 6/948 • 5 years	1.7% 16/957 • 5 years
Cardiac disorders Congestive heart failure	4.1% 39/948 • 5 years	5.2% 50/957 • 5 years
Cardiac disorders Coronary arteriospasm	0.00% 0/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Coronary artery dissection	2.4% 23/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Coronary artery embolism	0.00% 0/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Coronary artery graft occlusion	0.11% 1/948 • 5 years	3.6% 34/957 • 5 years
Cardiac disorders Coronary artery in-stent restenosis	2.8% 27/948 • 5 years	0.31% 3/957 • 5 years
Cardiac disorders Coronary artery occlusion	0.74% 7/948 • 5 years	0.63% 6/957 • 5 years
Cardiac disorders Coronary artery perforation	0.32% 3/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Coronary artery reocclusion	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Cardiac disorders Coronary artery stenosis	2.1% 20/948 • 5 years	0.84% 8/957 • 5 years
Cardiac disorders Coronary stent thrombosis	0.74% 7/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Electrocardiogram (ECG) abnormal	1.1% 10/948 • 5 years	1.5% 14/957 • 5 years
Cardiac disorders Hypertension	3.3% 31/948 • 5 years	4.4% 42/957 • 5 years
Cardiac disorders Hypertensive crisis	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Cardiac disorders Hypotension	3.4% 32/948 • 5 years	2.4% 23/957 • 5 years
Cardiac disorders Myocardial infarction	8.2% 78/948 • 5 years	6.1% 58/957 • 5 years
Cardiac disorders No-reflow phenomenon/slow flow	0.95% 9/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Other	10.9% 103/948 • 5 years	8.9% 85/957 • 5 years
Cardiac disorders Palpitations	1.3% 12/948 • 5 years	1.7% 16/957 • 5 years
Cardiac disorders Pericardial effusion	0.42% 4/948 • 5 years	1.1% 11/957 • 5 years
Cardiac disorders Plaque shift (tissue breakdown associated with device)	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Cardiac disorders Sick sinus syndrome	0.00% 0/948 • 5 years	0.21% 2/957 • 5 years
Cardiac disorders Tachycardia	1.3% 12/948 • 5 years	1.9% 18/957 • 5 years
Cardiac disorders Ventricular fibrillation	0.74% 7/948 • 5 years	0.52% 5/957 • 5 years
Cardiac disorders Ventricular tachycardia (sustained)	0.42% 4/948 • 5 years	0.84% 8/957 • 5 years
Endocrine disorders Diabetes mellitus	2.2% 21/948 • 5 years	2.0% 19/957 • 5 years
Endocrine disorders Hyperthyroidism	0.00% 0/948 • 5 years	0.31% 3/957 • 5 years
Endocrine disorders Hypothyroidism	0.63% 6/948 • 5 years	0.52% 5/957 • 5 years
Endocrine disorders Other	0.95% 9/948 • 5 years	1.9% 18/957 • 5 years
Gastrointestinal disorders Abdominal discomfort	0.53% 5/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Abdominal pain	1.7% 16/948 • 5 years	1.5% 14/957 • 5 years
Gastrointestinal disorders Colonic/intestinal polyp	1.3% 12/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Constipation	0.95% 9/948 • 5 years	1.4% 13/957 • 5 years
Gastrointestinal disorders Diarrhoea	1.9% 18/948 • 5 years	2.0% 19/957 • 5 years
Gastrointestinal disorders Dyspepsia	0.42% 4/948 • 5 years	0.10% 1/957 • 5 years
Gastrointestinal disorders Dysphagia	0.74% 7/948 • 5 years	0.21% 2/957 • 5 years
Gastrointestinal disorders Gastritis	0.42% 4/948 • 5 years	1.1% 11/957 • 5 years
Gastrointestinal disorders Gastroenteritis	0.53% 5/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Gastrointestinal ulcer/peptic ulcer	0.84% 8/948 • 5 years	0.31% 3/957 • 5 years
Gastrointestinal disorders Gastrooesophageal reflux diseases	1.3% 12/948 • 5 years	1.3% 12/957 • 5 years
Gastrointestinal disorders Hepatobiliary disease	1.2% 11/948 • 5 years	1.4% 13/957 • 5 years
Gastrointestinal disorders Intestinal obstruction	0.42% 4/948 • 5 years	0.52% 5/957 • 5 years
Gastrointestinal disorders Nausea	0.74% 7/948 • 5 years	2.1% 20/957 • 5 years
Gastrointestinal disorders Other	7.3% 69/948 • 5 years	6.4% 61/957 • 5 years
Gastrointestinal disorders Pancreatic disorder	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
Gastrointestinal disorders Vomiting	1.3% 12/948 • 5 years	1.8% 17/957 • 5 years
General disorders Accidents	0.00% 0/948 • 5 years	0.21% 2/957 • 5 years
General disorders Cataract	0.42% 4/948 • 5 years	0.84% 8/957 • 5 years
General disorders Chest pain (non-cardiac or non-specific)	3.2% 30/948 • 5 years	2.7% 26/957 • 5 years
General disorders Dehydration	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
General disorders Ear disorders	0.32% 3/948 • 5 years	0.21% 2/957 • 5 years
General disorders Ecchymosis	0.42% 4/948 • 5 years	0.10% 1/957 • 5 years
General disorders Edema peripheral	1.6% 15/948 • 5 years	1.8% 17/957 • 5 years
General disorders Eye disorders	0.32% 3/948 • 5 years	0.94% 9/957 • 5 years
General disorders Fall	1.1% 10/948 • 5 years	0.21% 2/957 • 5 years
General disorders Fatigue/Weakness	2.1% 20/948 • 5 years	2.6% 25/957 • 5 years
General disorders Fever/Pyrexia	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years
General disorders Headache	0.63% 6/948 • 5 years	0.31% 3/957 • 5 years
General disorders Injury	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
General disorders Other	5.6% 53/948 • 5 years	5.9% 56/957 • 5 years
General disorders Other shock	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
General disorders Pain	0.63% 6/948 • 5 years	0.84% 8/957 • 5 years
General disorders Pruritis	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
General disorders Rash	0.53% 5/948 • 5 years	0.63% 6/957 • 5 years
Immune system disorders Allergy to metal	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Immune system disorders Contrast media allergy/reaction	0.42% 4/948 • 5 years	0.00% 0/957 • 5 years
Immune system disorders Drug hypersensitivity/drug allergy	2.0% 19/948 • 5 years	1.1% 11/957 • 5 years
Immune system disorders Hypersensitivity/allergic reaction	1.2% 11/948 • 5 years	0.52% 5/957 • 5 years
Immune system disorders Other	0.84% 8/948 • 5 years	0.73% 7/957 • 5 years
Infections and infestations Bone and joint infections	0.74% 7/948 • 5 years	0.63% 6/957 • 5 years
Infections and infestations Cellulitis	1.3% 12/948 • 5 years	1.1% 11/957 • 5 years
Infections and infestations Deep sternal wound infection	0.11% 1/948 • 5 years	1.9% 18/957 • 5 years
Infections and infestations Flu/influenza	0.53% 5/948 • 5 years	0.21% 2/957 • 5 years
Infections and infestations Gastrointestinal infection	0.63% 6/948 • 5 years	0.94% 9/957 • 5 years
Infections and infestations Genitourinary infection	2.6% 25/948 • 5 years	4.5% 43/957 • 5 years
Infections and infestations Joint infection	0.00% 0/948 • 5 years	0.00% 0/957 • 5 years
Infections and infestations Lower respiratory tract infection	3.0% 28/948 • 5 years	6.0% 57/957 • 5 years
Infections and infestations Other	4.5% 43/948 • 5 years	6.4% 61/957 • 5 years
Infections and infestations Skin and subcutaneous infection	1.5% 14/948 • 5 years	3.6% 34/957 • 5 years
Infections and infestations Upper respiratory tract infection	2.7% 26/948 • 5 years	2.6% 25/957 • 5 years
Infections and infestations Vein harvest site infection	0.11% 1/948 • 5 years	2.0% 19/957 • 5 years
Injury, poisoning and procedural complications Catheter site hematoma	2.5% 24/948 • 5 years	0.10% 1/957 • 5 years
Injury, poisoning and procedural complications Catheter site pain	0.32% 3/948 • 5 years	0.00% 0/957 • 5 years
Injury, poisoning and procedural complications Catheter site swelling	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Injury, poisoning and procedural complications Cathether site bleeding	0.42% 4/948 • 5 years	0.00% 0/957 • 5 years
Injury, poisoning and procedural complications Other	1.3% 12/948 • 5 years	0.21% 2/957 • 5 years
Investigations Blood creatinine increased	1.3% 12/948 • 5 years	1.1% 11/957 • 5 years
Investigations Blood creatinine phosphokinase increased	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Investigations Elevated cardiac enzymes	4.6% 44/948 • 5 years	9.2% 88/957 • 5 years
Investigations Hematocrit decreased	0.11% 1/948 • 5 years	0.52% 5/957 • 5 years
Investigations Hemoglobin decreased	1.8% 17/948 • 5 years	3.7% 35/957 • 5 years
Investigations Hyperglycaemia	0.32% 3/948 • 5 years	1.7% 16/957 • 5 years
Investigations Hyperkalaemia	0.74% 7/948 • 5 years	0.94% 9/957 • 5 years
Investigations Hyperlipidaemia/hypercholesterolemia	0.53% 5/948 • 5 years	0.42% 4/957 • 5 years
Investigations Hypoglycemia	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Investigations Hypokalaemia	0.95% 9/948 • 5 years	1.1% 11/957 • 5 years
Investigations Liver function test abnormal	0.84% 8/948 • 5 years	1.5% 14/957 • 5 years
Investigations Other	1.5% 14/948 • 5 years	3.9% 37/957 • 5 years
Investigations Other abnormal blood test	0.42% 4/948 • 5 years	1.7% 16/957 • 5 years
Musculoskeletal and connective tissue disorders Arthritis	2.1% 20/948 • 5 years	1.7% 16/957 • 5 years
Musculoskeletal and connective tissue disorders Backpain	2.5% 24/948 • 5 years	2.4% 23/957 • 5 years
Musculoskeletal and connective tissue disorders Fracture	2.3% 22/948 • 5 years	3.1% 30/957 • 5 years
Musculoskeletal and connective tissue disorders Joint or tendon disease/disorder	2.2% 21/948 • 5 years	2.0% 19/957 • 5 years
Musculoskeletal and connective tissue disorders Muscle spasms	0.74% 7/948 • 5 years	0.52% 5/957 • 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.2% 49/948 • 5 years	6.3% 60/957 • 5 years
Musculoskeletal and connective tissue disorders Myalgia	1.9% 18/948 • 5 years	0.63% 6/957 • 5 years
Musculoskeletal and connective tissue disorders Other	7.3% 69/948 • 5 years	7.2% 69/957 • 5 years
Musculoskeletal and connective tissue disorders Spinal disorder	0.95% 9/948 • 5 years	0.84% 8/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Blood or lymphatic	0.53% 5/948 • 5 years	0.31% 3/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Gastrointestinal	1.4% 13/948 • 5 years	0.52% 5/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Musculoskeletal	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Nervous system	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Other	2.0% 19/948 • 5 years	1.7% 16/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Reproductive system	0.21% 2/948 • 5 years	0.31% 3/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Respiratory	1.4% 13/948 • 5 years	0.63% 6/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Skin or subcutaneous	1.4% 13/948 • 5 years	1.1% 11/957 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm/cancer : Urinary	0.84% 8/948 • 5 years	1.0% 10/957 • 5 years
Nervous system disorders Cerebrovascular accident (CVA)	3.1% 29/948 • 5 years	3.8% 36/957 • 5 years
Nervous system disorders Dizziness	1.2% 11/948 • 5 years	0.94% 9/957 • 5 years
Nervous system disorders Encephalopathy	0.53% 5/948 • 5 years	0.10% 1/957 • 5 years
Nervous system disorders Headache	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Nervous system disorders Other : Neurological/psychiatric disorders	3.0% 28/948 • 5 years	5.3% 51/957 • 5 years
Nervous system disorders Seizure/convulsion	0.32% 3/948 • 5 years	0.63% 6/957 • 5 years
Nervous system disorders Sleep disorder	0.00% 0/948 • 5 years	0.31% 3/957 • 5 years
Nervous system disorders Syncope/fainting/loss of consciousness	0.95% 9/948 • 5 years	0.63% 6/957 • 5 years
Nervous system disorders Transient ischemic attack (TIA)	1.1% 10/948 • 5 years	1.9% 18/957 • 5 years
Nervous system disorders Vertigo	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
Psychiatric disorders Agitation	0.11% 1/948 • 5 years	0.63% 6/957 • 5 years
Psychiatric disorders Anxiety	0.53% 5/948 • 5 years	0.84% 8/957 • 5 years
Psychiatric disorders Confusion	0.42% 4/948 • 5 years	0.73% 7/957 • 5 years
Psychiatric disorders Dementia	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Psychiatric disorders Depression	0.95% 9/948 • 5 years	0.94% 9/957 • 5 years
Psychiatric disorders Mental status change (including coma)	0.32% 3/948 • 5 years	0.10% 1/957 • 5 years
Psychiatric disorders Psychiatric disorder	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Renal and urinary disorders Benign prostatic hyperplasia	1.1% 10/948 • 5 years	0.73% 7/957 • 5 years
Renal and urinary disorders Incontinence	0.11% 1/948 • 5 years	0.21% 2/957 • 5 years
Renal and urinary disorders Nephrolithiasis	0.32% 3/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Other	3.4% 32/948 • 5 years	4.2% 40/957 • 5 years
Renal and urinary disorders Renal artery stenosis	0.11% 1/948 • 5 years	0.31% 3/957 • 5 years
Renal and urinary disorders Renal failure	2.2% 21/948 • 5 years	2.5% 24/957 • 5 years
Renal and urinary disorders Renal insufficiency/impairment	2.1% 20/948 • 5 years	2.9% 28/957 • 5 years
Renal and urinary disorders Urinary retention	0.84% 8/948 • 5 years	0.63% 6/957 • 5 years
Renal and urinary disorders Urinary stone/calculus	0.63% 6/948 • 5 years	0.94% 9/957 • 5 years
Renal and urinary disorders Urinary tract obstruction	0.21% 2/948 • 5 years	0.10% 1/957 • 5 years
Respiratory, thoracic and mediastinal disorders Asthma	0.42% 4/948 • 5 years	0.42% 4/957 • 5 years
Respiratory, thoracic and mediastinal disorders COPD (chronic obstructive pulmonary disease)	2.4% 23/948 • 5 years	2.0% 19/957 • 5 years
Respiratory, thoracic and mediastinal disorders Cough	0.84% 8/948 • 5 years	2.2% 21/957 • 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea/shortness of breath	6.1% 58/948 • 5 years	6.0% 57/957 • 5 years
Respiratory, thoracic and mediastinal disorders Other	5.4% 51/948 • 5 years	10.6% 101/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 11/948 • 5 years	6.6% 63/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 18/948 • 5 years	1.5% 14/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.74% 7/948 • 5 years	0.63% 6/957 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.11% 1/948 • 5 years	0.00% 0/957 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 15/948 • 5 years	4.0% 38/957 • 5 years
Vascular disorders Aneurysm	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years
Vascular disorders Arteriovenous fistula	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Vascular disorders Claudication	1.3% 12/948 • 5 years	1.7% 16/957 • 5 years
Vascular disorders Deep vein thrombosis	0.53% 5/948 • 5 years	0.73% 7/957 • 5 years
Vascular disorders Embolism	0.00% 0/948 • 5 years	0.10% 1/957 • 5 years
Vascular disorders Other	1.5% 14/948 • 5 years	2.0% 19/957 • 5 years
Vascular disorders Peripheral artery disease/peripheral venous disease	2.7% 26/948 • 5 years	2.8% 27/957 • 5 years
Vascular disorders Peripheral nerve lesion/injury	0.21% 2/948 • 5 years	0.21% 2/957 • 5 years
Vascular disorders Pseudoaneurysm	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Vascular disorders Stenosis	1.8% 17/948 • 5 years	1.1% 11/957 • 5 years
Vascular disorders Thrombophlebitis	0.32% 3/948 • 5 years	0.42% 4/957 • 5 years
Vascular disorders Thrombosis (non stent/non-coronary)	0.21% 2/948 • 5 years	0.42% 4/957 • 5 years
Vascular disorders Vascular occlusion	0.42% 4/948 • 5 years	0.63% 6/957 • 5 years

Additional Information

Rhonda Hensley, Clinical Project Manager

Abbott Vascular

Phone: +1 828-559-0080

Email: rhonda.hensley@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER