Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction, Stent Thrombosis, Vascular Disease
Conditions
Keywords
XIENCE PRIME EECSS, XIENCE V EECSS, XIENCE PRIME, SPIRIT PRIME, XIENCE PRIME SV (Small Vessel), XIENCE PRIME LL (Long Lesion), Coronary Artery Disease, Coronary Heart Disease, Cardiovascular Disease, Myocardial Infarction, Stent Thrombosis
Brief summary
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China. This study has no primary outcome measure. All observations are of equal weight.
Interventions
DEVICEXIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be at least 18 years of age at the time of signing the informed consent. * The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF). * Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.
Exclusion criteria
* No other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | ≤ 7 days after index procedure (Hospitalization) | 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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | ≤ 7 days after index procedure (Hospitalization) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | ≤ 7 days after index procedure (Hospitalization) | 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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | ≤ 7 days after index procedure (Hospitalization) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With Target Lesion Failure (TLF) | ≤ 7 days after index procedure (Hospitalization) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | ≤ 7 days after index procedure (Hospitalization) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | ≤ 7 days after index procedure (Hospitalization) | 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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | ≤ 7 days after index procedure (Hospitalization) | 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 This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With All Target Vessel Revascularization (TVR) | ≤ 7 days after index procedure (Hospitalization) | Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention |
| Number of Participants With Acute Stent Thrombosis | 0 to 1 day | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
| Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | 0 through 1885 Days | 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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With Early Stent Thrombosis | 0 - 30 days | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
| Number of Participants With Late Stent Thrombosis | 31 to 365 days | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
| Number of Participants With Very Late Stent Thrombosis | > 365 days | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
| Number of Participants With Overall Stent Thrombosis | 0 to 1885 days | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
| Number of Participants With Target Vessel ARC MI | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. |
| Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion) |
| Number of Participants With All TLR | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. |
| Number of Participants With ID-TLR | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. |
| Number of Participants With ID-TVR, Non-target Lesion | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. |
| Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | ≤ 7 days after index procedure (Hospitalization) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. |
| Number of Participants With Sub-acute Stent Thrombosis | > 1 day to 30 days | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation |
Countries
United States
Participant flow
Recruitment details
A total of 2140 patients were registered from 35 centres in China. First patients was enrolled on July 12, 2013 & enrollment was completed on Sep11, 2014 through the Interactive Voice Response System (IVRS) excluding those without consent and those without stent implants & duplicate entries. Thus the analysis population includes 2002 participants .
Pre-assignment details
Of the 2140 registered subjects,138 subjects withdrew from the study due to incomplete consent forms, no implanted study stents and repeated entry in voice interactive selection system. Among the final analysis population (n=2002), a total of 151 subjects failed to complete the follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | 2,002 |
| Total | 2,002 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No DMR and no Stent thrombosis | 151 |
Baseline characteristics
| Characteristic | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 716 Participants |
| Age, Categorical Between 18 and 65 years | 1286 Participants |
| Age, Continuous | 60.42 years STANDARD_DEVIATION 10.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2002 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 2002 Participants |
| Sex: Female, Male Female | 501 Participants |
| Sex: Female, Male Male | 1501 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 91 / 2,002 |
| other Total, other adverse events | 103 / 2,002 |
| serious Total, serious adverse events | 1,105 / 2,002 |
Outcome results
Primary
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | 7 Participants |
Other Pre-specified
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | 91 Participants |
Other Pre-specified
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | 3 Participants |
Other Pre-specified
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | 330 Participants |
Other Pre-specified
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | 8 Participants |
Other Pre-specified
Number of Participants With Acute Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 to 1 day
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Acute Stent Thrombosis | 0 Participants |
Other Pre-specified
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 75 Participants |
Other Pre-specified
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 6 Participants |
Other Pre-specified
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | 223 Participants |
Other Pre-specified
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | 1 Participants |
Other Pre-specified
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Target Vessel Revascularization (TVR) | 0 Participants |
Other Pre-specified
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All Target Vessel Revascularization (TVR) | 26 Participants |
Other Pre-specified
Number of Participants With All TLR
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All TLR | 1 Participants |
Other Pre-specified
Number of Participants With All TLR
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All TLR | 58 Participants |
Other Pre-specified
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | 84 Participants |
Other Pre-specified
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | 1 Participants |
Other Pre-specified
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | 114 Participants |
Other Pre-specified
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | 120 Participants |
Other Pre-specified
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | 5 Participants |
Other Pre-specified
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | 8 Participants |
Other Pre-specified
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | 156 Participants |
Other Pre-specified
Number of Participants With Early Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 - 30 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Early Stent Thrombosis | 2 Participants |
Other Pre-specified
Number of Participants With ID-TLR
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TLR | 37 Participants |
Other Pre-specified
Number of Participants With ID-TLR
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TLR | 1 Participants |
Other Pre-specified
Number of Participants With ID-TVR, Non-target Lesion
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TVR, Non-target Lesion | 0 Participants |
Other Pre-specified
Number of Participants With ID-TVR, Non-target Lesion
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TVR, Non-target Lesion | 22 Participants |
Other Pre-specified
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | 59 Participants |
Other Pre-specified
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | 1 Participants |
Other Pre-specified
Number of Participants With Late Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 31 to 365 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Late Stent Thrombosis | 1 Participants |
Other Pre-specified
Number of Participants With Overall Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Overall Stent Thrombosis | 3 Participants |
Other Pre-specified
Number of Participants With Sub-acute Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: > 1 day to 30 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Sub-acute Stent Thrombosis | 2 Participants |
Other Pre-specified
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Lesion Failure (TLF) | 5 Participants |
Other Pre-specified
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Lesion Failure (TLF) | 100 Participants |
Other Pre-specified
Number of Participants With Target Vessel ARC MI
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Vessel ARC MI | 2 Participants |
Other Pre-specified
Number of Participants With Target Vessel ARC MI
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 0 to 1885 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Vessel ARC MI | 23 Participants |
Other Pre-specified
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: ≤ 7 days after index procedure (Hospitalization)
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | 7 Participants |
Other Pre-specified
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame: 0 through 1885 Days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | 180 Participants |
Other Pre-specified
Number of Participants With Very Late Stent Thrombosis
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: > 365 days
Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Number of Participants With Very Late Stent Thrombosis | 0 Participants |