Trial Outcomes & Findings for XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS) (NCT NCT02513719)

NCT ID: NCT02513719

Last Updated: 2024-04-04

Results Overview

Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation

• Recruitment status: COMPLETED
• Target enrollment: 312 participants
• Primary outcome timeframe: 0-24 hours post stent implantation
• Results posted on: 2024-04-04

Participant Flow

A total of 312 subjects were enrolled from 30 sites. The enrollment period was from May 13, 2013 to March 25, 2014.

Participant milestones

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
At 8 Months Clinical Follow-up STARTED	312
At 8 Months Clinical Follow-up COMPLETED	312
At 8 Months Clinical Follow-up NOT COMPLETED	0
At 1 Year Clinical Follow-up STARTED	312
At 1 Year Clinical Follow-up COMPLETED	305
At 1 Year Clinical Follow-up NOT COMPLETED	7
At 2 Years Clinical Follow-up STARTED	305
At 2 Years Clinical Follow-up COMPLETED	300
At 2 Years Clinical Follow-up NOT COMPLETED	5
At 3 Years Clinical Follow-up STARTED	300
At 3 Years Clinical Follow-up COMPLETED	289
At 3 Years Clinical Follow-up NOT COMPLETED	11
At 4 Years Clinical Follow-up STARTED	289
At 4 Years Clinical Follow-up COMPLETED	273
At 4 Years Clinical Follow-up NOT COMPLETED	16
At 5 Years Clinical Follow-up STARTED	273
At 5 Years Clinical Follow-up COMPLETED	254
At 5 Years Clinical Follow-up NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Age, Continuous	69.6 years STANDARD_DEVIATION 10.0 • n=312 Participants
Sex: Female, Male Female	77 Participants n=312 Participants
Sex: Female, Male Male	235 Participants n=312 Participants
Region of Enrollment Japan	312 participants n=312 Participants

PRIMARY outcome

Timeframe: 0-24 hours post stent implantation

Population: Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.

Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timing:

Acute stent thrombosis: 0 to 24 hours after stent implantation

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Stent Thrombosis: Acute	1 Participants

PRIMARY outcome

Timeframe: >24 hours to 30 days post stent implantation

Population: ITT population.

Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Subacute stent thrombosis : >24 hours to 30 days after stent implantation

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Stent Thrombosis: Subacute	0 Participants

PRIMARY outcome

Timeframe: 30 days to 1 year post stent implantation

Population: ITT population.

Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Late stent thrombosis : >30 days to 1 year after stent implantation

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Stent Thrombosis: Late	1 Participants

SECONDARY outcome

Timeframe: >1 year post stent implantation

Population: ITT population.

Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Very late stent thrombosis : >1 year after stent implantation.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Stent Thrombosis: Very Late	0 Participants

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population.

The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=378 Target lesions QCA Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Percent Diameter Stenosis (%DS)	73.62 Percent Diameter stenosis Standard Deviation 16.20

SECONDARY outcome

Timeframe: post procedure (on day 0)

Population: ITT population.

The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=378 Target lesions QCA Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Percent Diameter Stenosis (%DS)	26.03 Percent Diameter stenosis Standard Deviation 12.94

SECONDARY outcome

Timeframe: 8 months

Population: The number of participants analyzed includes subjects who received angiographic follow-up at 8 months.

The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=239 Target lesions Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Percent Diameter Stenosis (%DS)	28.31 Percent Diameter stenosis Standard Deviation 17.02

SECONDARY outcome

Timeframe: < or = 1 day

The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm.

Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=335 XIENCE PRIME SV stents Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Success Rate: Percentage of Devices With Implant Success	100 percentage of devices Interval 99.1 to 100.0

SECONDARY outcome

Timeframe: < or = 1 day

Population: ITT population.

Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=326 Lesions Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Success Rate: Percentage of Lesions With Procedural Success	100 Percentage of lesions Interval 99.1 to 100.0

SECONDARY outcome

Timeframe: < or = 1 day

Population: ITT population.

The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm.

Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Success Rate: XIENCE PRIME Implant Success by Patient	100 participants Interval 99.0 to 100.0

SECONDARY outcome

Timeframe: 0 to 8 months

Population: Intent-to-treat (ITT) population.

Death includes cardiac death, non-cardiac death and non-coronary death.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	4 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Intent-to-treat (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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	7 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	11 Participants

SECONDARY outcome

Timeframe: 0-3 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	20 Participants

SECONDARY outcome

Timeframe: 0-4 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	25 Participants

SECONDARY outcome

Timeframe: 0-５ 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Death	30 Participants

SECONDARY outcome

Timeframe: 0 to 8 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	2 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	2 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	3 Participants

SECONDARY outcome

Timeframe: 0-3 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	4 Participants

SECONDARY outcome

Timeframe: 0-4 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	4 Participants

SECONDARY outcome

Timeframe: 0-5 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Myocardial Infarction	5 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	9 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	16 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	22 Participants

SECONDARY outcome

Timeframe: 0-3 years

Population: ITT

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	25 Participants

SECONDARY outcome

Timeframe: 0-4 years

Population: ITT

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	26 Participants

SECONDARY outcome

Timeframe: 0-5 years

Population: ITT

Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Revascularization	27 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	21 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	34 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

The number of patient with Ischemia-driven Target vessel revascularization (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	42 Participants

SECONDARY outcome

Timeframe: 0-3 years

Population: ITT popuation

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	45 Participants

SECONDARY outcome

Timeframe: 0-4 years

Population: ITT popuation

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	47 Participants

SECONDARY outcome

Timeframe: 0-5 years

Population: ITT popuation

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	51 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	16 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	32 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	42 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	45 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	55 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	58 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	34 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	59 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	73 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	78 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	85 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Revascularization	88 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening:

Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention

Moderate:

Bleeding that requires blood transfusion but does not result in hemodynamic compromise

Mild:

Bleeding that does not meet criteria for either moderate or severe bleeding

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening:

Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention

Moderate:

Bleeding that requires blood transfusion but does not result in hemodynamic compromise

Mild:

Bleeding that does not meet criteria for either moderate or severe bleeding

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening:

Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention

Moderate:

Bleeding that requires blood transfusion but does not result in hemodynamic compromise

Mild:

Bleeding that does not meet criteria for either moderate or severe bleeding

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	2 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	4 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	4 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Hemorrhage	4 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	8 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	11 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	16 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	21 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	21 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Lesion Failure	25 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	38 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	66 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	84 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	96 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	106 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With All Death/All MI/All Revascularization	111 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

Target vessel failure includes cardiac death, MI, ischemia driven TLR, ischemia driven TVR, non TLR and ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	16 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	22 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	30 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	35 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	39 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Target Vessel Failure	45 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	9 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	12 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	18 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	23 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	23 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Major Adverse Cardiac Events (MACE)	28 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

All deaths includes

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

Myocardial Infarction (MI)

• Q wave MI Development of new, pathological Q wave on the ECG.
• Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	6 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

All deaths includes

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

Myocardial Infarction (MI)

• Q wave MI Development of new, pathological Q wave on the ECG.
• Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	9 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	14 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	22 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	27 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Death or MI	33 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

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.)

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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	5 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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.) 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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	5 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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.)

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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	6 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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.)

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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	8 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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.)

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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	8 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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.)

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	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or MI	12 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target-Vessel MI	4 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target Vessel-MI	5 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target Vessel MI	4 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target Vessel MI	6 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target Vessel MI	6 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population.

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).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 Participants Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Number of Participants With Cardiac Death or Target Vessel MI	9 Participants

SECONDARY outcome

Timeframe: Pre procedure to post procedure (on day 0)

Population: ITT population.

The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=378 Target lesions Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Acute Gain: In-stent,In-segment Stent	1.56 Millimeter Standard Deviation 0.46
Acute Gain: In-stent,In-segment Segment	1.16 Millimeter Standard Deviation 0.48

SECONDARY outcome

Timeframe: 8 months

Population: ITT population

Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=378 Target lesions Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Late Loss(LL): In-stent,In-segment,Proximal, and Distal Stent	0.23 Millimeter Standard Deviation 0.40
Late Loss(LL): In-stent,In-segment,Proximal, and Distal Proximal	0.13 Millimeter Standard Deviation 0.32
Late Loss(LL): In-stent,In-segment,Proximal, and Distal Distal	-0.03 Millimeter Standard Deviation 0.35
Late Loss(LL): In-stent,In-segment,Proximal, and Distal Segment	0.09 Millimeter Standard Deviation 0.52

SECONDARY outcome

Timeframe: Post-Procedure (on day 0)

Difference between acute gain and late loss.

Outcome measures

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=378 Target lesions Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Net Gain: In-stent, In-segment Stent	1.31 Millimeter Standard Deviation 0.48
Net Gain: In-stent, In-segment Segment	1.08 Millimeter Standard Deviation 0.52

Adverse Events

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Serious events: 165 serious events

Other events: 0 other events

Deaths: 39 deaths

Serious adverse events

Measure	XIENCE PRIME SV Everolimus Eluting Coronary Stent n=312 participants at risk Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Blood and lymphatic system disorders Anemia	0.32% 1/312 • 5 years
Cardiac disorders Acute myocardial infarction	0.96% 3/312 • 5 years
Cardiac disorders Angina pectoris	9.6% 30/312 • 5 years
Cardiac disorders Angina unstable	3.2% 10/312 • 5 years
Cardiac disorders Cardiac failure acute	0.64% 2/312 • 5 years
Cardiac disorders Cardiac failure chronic	0.64% 2/312 • 5 years
Cardiac disorders Cardio-respiratory arrest	0.32% 1/312 • 5 years
Cardiac disorders Coronary artery dissection	0.32% 1/312 • 5 years
Cardiac disorders Coronary artery stenosis	25.6% 80/312 • 5 years
Cardiac disorders Heart failures	6.7% 21/312 • 5 years
Cardiac disorders Intracardiac thrombus	0.32% 1/312 • 5 years
Cardiac disorders Myocardial infarction	0.32% 1/312 • 5 years
Cardiac disorders Myocardial ischemia	0.32% 1/312 • 5 years
Cardiac disorders Pericardial effusion	0.64% 2/312 • 5 years
Cardiac disorders Sick sinus syndrome	0.32% 1/312 • 5 years
Cardiac disorders Ventricular arrhythmia	0.64% 2/312 • 5 years
Ear and labyrinth disorders Meniere's disease	0.32% 1/312 • 5 years
Ear and labyrinth disorders Sudden hearing loss	0.32% 1/312 • 5 years
Eye disorders Cataract	0.32% 1/312 • 5 years
Gastrointestinal disorders Diverticulitis intestinal hemorrhagic	0.32% 1/312 • 5 years
Gastrointestinal disorders Gastrointestinal hemorrhage	0.96% 3/312 • 5 years
Gastrointestinal disorders Inguinal hernia	0.32% 1/312 • 5 years
Gastrointestinal disorders Ischemic colitis	0.32% 1/312 • 5 years
Gastrointestinal disorders Lower digestive tract haemorrhage	0.32% 1/312 • 5 years
General disorders Multi-organ failure	0.32% 1/312 • 5 years
General disorders Death	2.6% 8/312 • 5 years
Hepatobiliary disorders Cholangitis acute	0.32% 1/312 • 5 years
Hepatobiliary disorders Cholelithiasis	0.32% 1/312 • 5 years
Hepatobiliary disorders Drug-induced liver injury	0.32% 1/312 • 5 years
Immune system disorders Drug Hypersensitivity	0.32% 1/312 • 5 years
Infections and infestations Bacterial Pneumonia	0.32% 1/312 • 5 years
Infections and infestations Herpes zoster	0.64% 2/312 • 5 years
Infections and infestations Pneumonia	2.9% 9/312 • 5 years
Injury, poisoning and procedural complications Anemia postoperative	0.32% 1/312 • 5 years
Injury, poisoning and procedural complications Coronary artery restenosis	8.0% 25/312 • 5 years
Injury, poisoning and procedural complications Femoral fracture	0.64% 2/312 • 5 years
Injury, poisoning and procedural complications Ligament injury	0.32% 1/312 • 5 years
Injury, poisoning and procedural complications Shunt stenosis	0.96% 3/312 • 5 years
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.32% 1/312 • 5 years
Investigations Cardiac enzymes increased	0.32% 1/312 • 5 years
Metabolism and nutrition disorders Diabetes mellitus	0.96% 3/312 • 5 years
Metabolism and nutrition disorders Hyperglycemia	0.64% 2/312 • 5 years
Musculoskeletal and connective tissue disorders Foot Deformation	0.32% 1/312 • 5 years
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.96% 3/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.96% 3/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.96% 3/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.6% 5/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.64% 2/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cancer	0.64% 2/312 • 5 years
Nervous system disorders Cerebral hemorrhage	1.3% 4/312 • 5 years
Nervous system disorders Cerebral infarction	3.2% 10/312 • 5 years
Nervous system disorders Syncope	0.32% 1/312 • 5 years
Renal and urinary disorders Bladder prolapse	0.32% 1/312 • 5 years
Renal and urinary disorders Renal artery stenosis	0.32% 1/312 • 5 years
Renal and urinary disorders Renal failure	0.64% 2/312 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.32% 1/312 • 5 years
Surgical and medical procedures Coronary revascularisation	0.64% 2/312 • 5 years
Vascular disorders Peripheral arterial occlusive disease	6.4% 20/312 • 5 years
Vascular disorders Peripheral artery stenosis	0.64% 2/312 • 5 years
Vascular disorders Peripheral artery thrombosis	0.32% 1/312 • 5 years
Nervous system disorders Cerebral artery embolism	0.32% 1/312 • 5 years
Nervous system disorders Cerebellar infarction	0.32% 1/312 • 5 years
Eye disorders Glaucoma	0.32% 1/312 • 5 years
Cardiac disorders Aortic valve stenosis	0.32% 1/312 • 5 years
Gastrointestinal disorders Gastric ulcer hemorrhage	0.32% 1/312 • 5 years
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.32% 1/312 • 5 years
Musculoskeletal and connective tissue disorders Spinal stenosis	0.32% 1/312 • 5 years
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.32% 1/312 • 5 years
General disorders Device related thrombosis	0.96% 3/312 • 5 years
Gastrointestinal disorders Gastric ulcer	0.32% 1/312 • 5 years
Respiratory, thoracic and mediastinal disorders Interstitial pneumonia	0.32% 1/312 • 5 years
Gastrointestinal disorders Ileus	0.32% 1/312 • 5 years
Hepatobiliary disorders Cholecystitis	0.32% 1/312 • 5 years
Renal and urinary disorders Nephrosis	0.32% 1/312 • 5 years
Renal and urinary disorders Acute renal failure	0.32% 1/312 • 5 years
General disorders Pyrexia	0.32% 1/312 • 5 years
Investigations Exercise test abnormal	0.32% 1/312 • 5 years
Injury, poisoning and procedural complications Injury	0.32% 1/312 • 5 years
Vascular disorders Thrombophlebitis	0.32% 1/312 • 5 years
Cardiac disorders Aortic regurgitation	0.32% 1/312 • 5 years
Cardiac disorders Atrial fibrillation	0.64% 2/312 • 5 years
Cardiac disorders Complete AV block	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic cancer	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureter cancer	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic liver cancer	0.32% 1/312 • 5 years
Metabolism and nutrition disorders Type II diabetes mellitus	0.32% 1/312 • 5 years
Nervous system disorders Dizziness	0.32% 1/312 • 5 years
Ear and labyrinth disorders Inner ear disorder	0.32% 1/312 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic prostatic cancer	0.32% 1/312 • 5 years
Immune system disorders Sarcoidosis	0.64% 2/312 • 5 years
Nervous system disorders Ischiadic nerve neuropathy	0.64% 2/312 • 5 years
Musculoskeletal and connective tissue disorders Arthritis	0.32% 1/312 • 5 years
Gastrointestinal disorders Hemorrhoids	0.32% 1/312 • 5 years
Gastrointestinal disorders Large intestine hemorrhage	0.32% 1/312 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Kusano Hajime

Abbott Vascular

Phone: 408-645-1626

Email: hajime.kusano@av.abbott.com

Results disclosure agreements

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

Restriction type: LTE60