Trial Outcomes & Findings for XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study (NCT NCT01249027)

NCT ID: NCT01249027

Last Updated: 2019-03-01

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 2605 participants
• Primary outcome timeframe: 0 to 407 days
• Results posted on: 2019-03-01

Participant Flow

XIENCE V China SAS was designed to enroll approximately 2500 patients. The first patient was enrolled on November 26, 2010. The enrollment was completed on December 10, 2011, with a total of 2605 patients enrolled at 53 sites. Of 2605 patients, a total of 123 subjects were withdrawn. Per protocol population is 2482.

A total of 123 subjects were withdrawn due to following reasons: 82 subjects had incomplete informed consent procedures;11 subjects enrolled repeatedly;1 subject did not have a stent at the starting point for surgery;18 subjects surgically implanted with other stents at the start;1 subject withdrew informed consent;10 subjects deregistered.

Participant milestones

Measure	Observational Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
1 Year Clinical Follow up STARTED	2482
1 Year Clinical Follow up COMPLETED	2391
1 Year Clinical Follow up NOT COMPLETED	91
2 Years Clinical Follow up STARTED	2391
2 Years Clinical Follow up COMPLETED	2254
2 Years Clinical Follow up NOT COMPLETED	137
3 Years Clinical Follow up STARTED	2254
3 Years Clinical Follow up COMPLETED	2223
3 Years Clinical Follow up NOT COMPLETED	31
4 Years Clinical Follow up STARTED	2223
4 Years Clinical Follow up COMPLETED	2210
4 Years Clinical Follow up NOT COMPLETED	13
5 Years Clinical Follow up STARTED	2210
5 Years Clinical Follow up COMPLETED	2142
5 Years Clinical Follow up NOT COMPLETED	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

Baseline characteristics by cohort

Measure	Observational n=2482 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1586 Participants n=5 Participants
Age, Categorical >=65 years	896 Participants n=5 Participants
Age, Continuous	60.69 years STANDARD_DEVIATION 11.13 • n=5 Participants
Sex: Female, Male Female	626 Participants n=5 Participants
Sex: Female, Male Male	1856 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	33 Participants

PRIMARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	55 Participants

PRIMARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	63 Participants

PRIMARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	76 Participants

PRIMARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	84 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-followup, defined as subjects who are lost to followup through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Definite Stent Thrombosis (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 48hours:

• Acute onset of ischemic symptoms at rest
• New ischemic ECG changes
• Typical rise&fall in cardiac biomarkers
• Nonocclusive &occlusive thrombus

Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.

Probable ST may occur 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 ST&in the absence of any other obvious cause.

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Stent Thrombosis Definite	5 Participants
Number of Participants With Stent Thrombosis Definite & Probable	10 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	90 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	154 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	191 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	235 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	271 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Cardiac 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).

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.

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	35 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Cardiac 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).

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.

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	62 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Cardiac 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).

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.

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	71 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Cardiac 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).

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.

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	87 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Cardiac 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).

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.

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	95 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	35 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	60 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	69 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	85 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	93 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of

• Cardiac death,
• Myocardial infarction (Q wave and Non-Q wave),
• Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
• Ischemia-driven target vessel revascularization by CABG or PCI.

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	50 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of

• Cardiac death,
• Myocardial infarction (Q wave and Non-Q wave),
• Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
• Ischemia-driven target vessel revascularization by CABG or PCI.

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	86 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of

• Cardiac death,
• Myocardial infarction (Q wave and Non-Q wave),
• Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
• Ischemia-driven target vessel revascularization by CABG or PCI.

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	100 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of

• Cardiac death,
• Myocardial infarction (Q wave and Non-Q wave),
• Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
• Ischemia-driven target vessel revascularization by CABG or PCI.

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	123 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of

• Cardiac death,
• Myocardial infarction (Q wave and Non-Q wave),
• Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
• Ischemia-driven target vessel revascularization by CABG or PCI.

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	136 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death and Any MI	46 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death and Any MI	80 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death and Any MI	92 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death and Any MI	120 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Composite Rate of All Death and Any MI	137 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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).

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Experiencing Death	34 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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).

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Experiencing Death	64 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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).

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Experiencing Death	75 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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).

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Experiencing Death	98 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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).

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Experiencing Death	113 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Any MI	13 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Any MI	20 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Any MI	23 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Any MI	28 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Any MI	31 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Revascularization	49 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Revascularization	83 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Revascularization	111 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Revascularization	132 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Revascularization	154 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

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	Observational n=2388 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	14 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

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	Observational n=2231 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	18 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

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	Observational n=2160 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	26 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

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	Observational n=2126 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	31 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

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	Observational n=2029 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	18 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.

Outcome measures

Measure	Observational n=2384 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	2231 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.

Outcome measures

Measure	Observational n=2225 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	1085 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.

Outcome measures

Measure	Observational n=2151 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	934 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.

Outcome measures

Measure	Observational n=2116 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	879 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.

Outcome measures

Measure	Observational n=2029 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	800 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Lesions Revascularization	12 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Lesion Revascularization	21 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Lesions Revascularization	25 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Lesion Revascularization	30 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Lesion Revascularization	33 Participants

SECONDARY outcome

Timeframe: 0 to 407 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2391 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Vessel Revascularization	20 Participants

SECONDARY outcome

Timeframe: 0 to 772 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2254 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Vessel Revascularization	36 Participants

SECONDARY outcome

Timeframe: 0 to 1137 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2223 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Vessel Revascularization	42 Participants

SECONDARY outcome

Timeframe: 0 to 1502 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2210 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Vessel Revascularization	53 Participants

SECONDARY outcome

Timeframe: 0 to 1867 days

Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

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.

Outcome measures

Measure	Observational n=2142 Participants Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Number of Participants With All Target Vessel Revascularization	60 Participants

Adverse Events

Observational

Serious events: 574 serious events

Other events: 113 other events

Deaths: 113 deaths

Serious adverse events

Measure	Observational n=2482 participants at risk Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
General disorders Stomach bleeding	0.28% 7/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Stent thrombosis	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Hepatobiliary disorders Cholecystitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Hepatobiliary disorders GallStone And Cholecystitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Infections and infestations Common Cold	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Infections and infestations Otter disease	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Infections and infestations Upper Respiratory Tract Infection	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Artery embolization	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Bone fracture	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Cerebral Hemorrhage	0.48% 12/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Coronary artery revascularization and Coronary artery bypass grafting	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Distal Stent Restenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Multiple rib fractures	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Muscle strain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Non-Target Vessel Revascularization	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Percutaneous Coronary Intervention (PCI)	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Post-operative Percutaneous Coronary Intervention (PCI)	0.20% 5/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Receiving catheter radiofrequency ablation	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Restenosis	0.20% 5/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Revascularization	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Stenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Stent Stenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Stent restenosis	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Subarachnoid Hemorrhage	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Subdural Hematoma	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Upper Extremity Artery Stenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Metabolism and nutrition disorders Diabetes	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Metabolism and nutrition disorders Newly Discovered Diabetes Mellitus	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Metabolism and nutrition disorders Type II Diabetes	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Advanced Gastric Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Duodenal Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney tumor metastasis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver Cancer	0.24% 6/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.32% 8/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Liver Tumors	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Right groin tumor	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Stomach lymphoma	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat Malignant Tumor	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Cerebral Infarction	0.64% 16/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Cerebral Insufficiency	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Cerebral Thrombosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Convulsions	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Dizziness	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Ischemic stroke	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Peripheral Neuropathy	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Syncope	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Renal and urinary disorders Acute pyelonephritis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Renal and urinary disorders Kidney stones	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Renal and urinary disorders Prostate hyperplasia and urinary incontinence	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Renal and urinary disorders Renal Insufficiency	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Reproductive system and breast disorders Prostatitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Respiratory, thoracic and mediastinal disorders Bronchitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Respiratory, thoracic and mediastinal disorders Lung Infection	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Skin and subcutaneous tissue disorders Subcutaneous Bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Surgical and medical procedures All Coronary Revascularizations	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary Artery Stenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Surgical and medical procedures Coronary Stent Restenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Heart surgery	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Hernia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Blood pressure instability	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Carotid Stenosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Hypertension	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Hypertension deterioration	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Left anterior descending (LAD) proximal stent occlusion	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Myocardial Infarction	0.85% 21/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Non-ST segment elevation myocardial infarction (NSTEMI)	0.24% 6/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Old Myocardial Infarction	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Palpitation	0.28% 7/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Palpitation and Atrial fibrillation	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Paroxysmal Atrial Fibrillation	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Proximal right coronary artery (RCA) stenosis, not within the stent	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Sequelae of cerebral infarction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Stable Angina	0.44% 11/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Unstable Angina	4.8% 119/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Ventricular Tachycardia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Ventricular extrasystole	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Ear and labyrinth disorders Deaf	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Endocrine disorders Brain dysfunction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Acute Gastroenteritis	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Acute Intestinal Obstruction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Appendicitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Biliary colic	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Duodenal ulcer	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gallstone	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastritis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastroenteritis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastrointestinal Bleeding	0.20% 5/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Incomplete intestinal obstruction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Intestinal obstruction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Upper Gastrointestinal Bleeding	0.24% 6/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Abdominal Pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Atypical chest pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Bleeding Gums	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Discomfort	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Pain	1.2% 29/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Tightness	1.0% 25/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest pain and chest tightness	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Colon Occupy	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Complex Ulcer Bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Death	2.1% 51/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Hospitalization	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Hypovolemic Shock	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Intermittent Hemoptysis and Generalized Pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Intracranial Bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Low Back Pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Multiple Organ Failure	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Precordial discomfort	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Precordial pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Rehospitalization	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Severe bleeding complications	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Shortness of breath and Chest tightness	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Sick Sinus Syndrome	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute Heart Failure	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute Left Heart Failure	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute Left Ventricular Failure	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute Myocardial Infarction (AMI)	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute coronary syndrome (ACS)	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Acute coronary syndrome and heart failure	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Adams-Stokes Syndrome (Ventricular fibrillation (VF))	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Angina	4.9% 121/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Angina and Coronary Heart Disease	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Arrhythmia	0.32% 8/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Atrial Fibrillation and Tachycardia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Atrial fibrillation	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Atrioventricular (AV) Block	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Bradycardia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiac Arrest	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiac Function Insufficiency	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiac Rupture	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiac death	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiogenic shock	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Cardiopulmonary disease	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary Artery Disease recurrence	0.20% 5/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary Atherosclerotic Heart Disease	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary Heart Disease	2.3% 56/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary artery disease	0.32% 8/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary artery revascularization	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Coronary heart disease worsened	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Heart Disease	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Heart Failure	0.97% 24/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Ischemic cardiomyopathy	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Labor angina	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).

Other adverse events

Measure	Observational n=2482 participants at risk Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Hepatobiliary disorders Abnormal liver enzymes	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Angina	0.44% 11/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Arrhythmia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Atrial Fibrillation	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Severe dizziness	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Bleeding	0.20% 5/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Bleeding gums	0.36% 9/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Blood in the stool	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Investigations Cardiac Troponin I (Ctni) Increased	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Cerebral Infarction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Pain	0.24% 6/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Tightness	0.28% 7/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Chest Tightness and Chest Pain	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Congestive Heart Failure	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Skin and subcutaneous tissue disorders Dermatitis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Metabolism and nutrition disorders Diabetes	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Nervous system disorders Dizziness	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Eye disorders Eye Bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Fundus Hemorrhage	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastric Ulcer	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastrointestinal Bleeding	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Gastrointestinal discomfort	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Hand injury	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Heart Failure	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Hemoptysis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Hemorrhoids	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Hypertension	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Metabolism and nutrition disorders Hyperthyroidism	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Hypotension	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Investigations Increased myocardial enzymes	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Intermittent chest tightness	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Ischemic cardiomyopathy	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Labor angina	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Left Subconjunctival Hemorrhage	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Myocardial Infarction	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Myocardial hypertrophy	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Musculoskeletal and connective tissue disorders Myositis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Nose bleeding	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Occult blood	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Eye disorders Ocular hyperemia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Investigations Positive occult blood test	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Investigations Postoperative Cardiac Troponin I (Ctni) Increased	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Investigations Postoperative Troponin I (TnI) Increased	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Vascular disorders Right Femoral Vein Thrombosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Right lung adenocarcinoma	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Severe palpitation	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Side effects of Aspirin	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Sinus Bradycardia	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Skin and subcutaneous tissue disorders Skin Bruises	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Skin and subcutaneous tissue disorders Skin ecchymosis	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Stable angina	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Stomach Bleeding	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Stomach discomfort	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Stomach pain	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Injury, poisoning and procedural complications Subcutaneous Bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
General disorders Throat bleeding	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Cardiac disorders Unstable Angina	0.16% 4/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Upper Gastrointestinal Bleeding	0.08% 2/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Upper abdominal discomfort	0.04% 1/2482 • 5 years Safety data was assessed based on the per protocol population (2482).
Gastrointestinal disorders Upper gastrointestinal bleeding	0.12% 3/2482 • 5 years Safety data was assessed based on the per protocol population (2482).

Additional Information

Leong Roy

Abbott Vascular

Phone: 8133 7475

Email: roy.leong@abbott.com

Results disclosure agreements

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

Restriction type: LTE60