Trial Outcomes & Findings for XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan (NCT NCT01086228)
NCT ID: NCT01086228
Last Updated: 2018-02-19
Results Overview
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. 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. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
COMPLETED
2010 participants
Post Procedure to 1 Year
2018-02-19
Participant Flow
A total of 2010 patients were registered. Of which 1 patient was excluded from this analysis. Therefore, 2009 patients (1,159 patients treated with XIENCE V; 850 patients treated with PROMUS) were included in the analysis.
Study has excluded those patients who were treated with stents other than CoCr-EES (XIENCE V or PROMUS), or underwent concomitant treatment of a graft vessel. Patients were invited to enroll in the study after apparently successful per-cutaneous coronary intervention (PCI).
Participant milestones
| Measure |
XIENCE V / PROMUS Stent
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
8 Month Follow-up
STARTED
|
2009
|
|
8 Month Follow-up
COMPLETED
|
1938
|
|
8 Month Follow-up
NOT COMPLETED
|
71
|
|
1-year Follow-up
STARTED
|
1938
|
|
1-year Follow-up
COMPLETED
|
1894
|
|
1-year Follow-up
NOT COMPLETED
|
44
|
|
2-year Follow-up
STARTED
|
1894
|
|
2-year Follow-up
COMPLETED
|
1834
|
|
2-year Follow-up
NOT COMPLETED
|
60
|
|
3-year Follow-up
STARTED
|
1834
|
|
3-year Follow-up
COMPLETED
|
1767
|
|
3-year Follow-up
NOT COMPLETED
|
67
|
|
4-year Follow-up
STARTED
|
1767
|
|
4-year Follow-up
COMPLETED
|
1664
|
|
4-year Follow-up
NOT COMPLETED
|
103
|
|
5-year Follow-up
STARTED
|
1664
|
|
5-year Follow-up
COMPLETED
|
1012
|
|
5-year Follow-up
NOT COMPLETED
|
652
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
Baseline characteristics by cohort
| Measure |
XIENCE V / PROMUS Stent
n=2009 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
481 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1528 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
2009 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post Procedure to 1 YearDefinite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. 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. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=2009 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite Stent Thrombosis
|
6 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Probable Stent Thrombosis
|
2 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Possible Stent Thrombosis
|
6 participants
|
PRIMARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. 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. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1894 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite Stent Thrombosis
|
0 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Probable Stent Thrombosis
|
0 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Possible Stent Thrombosis
|
5 participants
|
PRIMARY outcome
Timeframe: From 2 years to 3 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. 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. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1834 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite Stent Thrombosis
|
0 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Probable Stent Thrombosis
|
0 participants
|
|
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Possible Stent Thrombosis
|
4 participants
|
SECONDARY outcome
Timeframe: From post-procedure to 1 yearOutcome measures
| Measure |
XIENCE V / PROMUS Stent
n=2009 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Bleeding
|
32 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cardiac
|
3 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Abnormal Non-Cardiac Lab Value/Test
|
13 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Allergic Reaction
|
10 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cancer/Tumor
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Gastro-intestinal
|
4 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
General/Musculoskeletal/Connective
|
7 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Genito-urinary and renal disorder
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Neurological/Psychiatric disorders
|
3 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Vascular
|
4 participants
|
SECONDARY outcome
Timeframe: From 1 year to 2 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1894 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Abnormal Non-Cardiac Lab Value/Test
|
2 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Allergic Reaction
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Bleeding
|
5 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cardiac
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cancer/Tumor
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Gastro-intestinal
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
General/Musculoskeletal/Connective
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Genito-urinary and renal disorder
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Neurological/Psychiatric disorders
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Vascular
|
0 participants
|
SECONDARY outcome
Timeframe: From 2 years to 3 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1834 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Abnormal Non-Cardiac Lab Value/Test
|
2 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Allergic Reaction
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Bleeding
|
3 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cardiac
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cancer/Tumor
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Gastro-intestinal
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
General/Musculoskeletal/Connective
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Genito-urinary and renal disorder
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Neurological/Psychiatric disorders
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Vascular
|
0 participants
|
SECONDARY outcome
Timeframe: From 3 years to 4 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1767 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Abnormal Non-Cardiac Lab Value/Test
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Allergic Reaction
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Bleeding
|
9 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cardiac
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cancer/Tumor
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Gastro-intestinal
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
General/Musculoskeletal/Connective
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Genito-urinary and renal disorder
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Neurological/Psychiatric disorders
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Vascular
|
2 participants
|
SECONDARY outcome
Timeframe: From 4 years to 5 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1664 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Abnormal Non-Cardiac Lab Value/Test
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Allergic Reaction
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Bleeding
|
3 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cardiac
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Cancer/Tumor
|
0 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Gastro-intestinal
|
2 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
General/Musculoskeletal/Connective
|
2 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Genito-urinary and renal disorder
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Neurological/Psychiatric disorders
|
1 participants
|
|
Number of Participants With Adverse Events Related to Anti-platelet Medication
Vascular
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1850 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Percent Diameter Stenosis (%DS)
|
69.6 Percent Diameter stenosis
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: On day 0 after procedurePopulation: Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1850 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Percent Diameter Stenosis (%DS)
|
23.6 Percent Diameter stenosis
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: At 8 monthsPopulation: Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1309 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Percent Diameter Stenosis (%DS)
|
26.1 Percent Diameter stenosis
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: On day 0 after procedurePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1850 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Acute Gain
In-stent (n=1845 lesions)
|
1.769 millimeters
Interval 1.744 to 1.794
|
|
Acute Gain
In-segment (n=1846 lesions)
|
1.409 millimeters
Interval 1.383 to 1.436
|
SECONDARY outcome
Timeframe: On day 0 after procedurePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\].
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1850 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Late Loss
In-stent (n=1303 lesions)
|
0.219 millimeters
Interval 0.196 to 0.243
|
|
Late Loss
Proximal (n=1086 lesions)
|
0.152 millimeters
Interval 0.125 to 0.178
|
|
Late Loss
Distal (n=1298 lesions)
|
0.034 millimeters
Interval 0.012 to 0.055
|
|
Late Loss
In-segment (n=1308 lesions)
|
0.128 millimeters
Interval 0.099 to 0.157
|
SECONDARY outcome
Timeframe: On day 0 after procedurePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Net Gain = Acute Gain - Late Loss, paired analysis only.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1850 lesions
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Net Gain
In-segment (n=1305 lesions)
|
1.269 millimeters
Interval 1.235 to 1.302
|
|
Net Gain
In-stent (n=1300 lesions)
|
1.536 millimeters
Interval 1.504 to 1.568
|
SECONDARY outcome
Timeframe: On day 0 (Immediately post-index procedure)Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: * Stent was successfully delivered to the intended location * Stent was successfully deployed at the intended location * Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=3104 stents
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Acute Success
Success
|
99.94 percentage of stents
|
|
Acute Success
Unknown
|
0.06 percentage of stents
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
|
47 participants
|
SECONDARY outcome
Timeframe: From 1 to 2 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
|
80 participants
|
SECONDARY outcome
Timeframe: From 2 years to 3 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
|
109 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Myocardial Infarctions (MI)
|
17 participants
|
SECONDARY outcome
Timeframe: From 1 year to 2 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Myocardial Infarctions (MI)
|
30 participants
|
SECONDARY outcome
Timeframe: From 2 years to 3 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Myocardial Infarctions (MI)
|
33 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Lesion Revascularization (TLR)
|
72 participants
|
SECONDARY outcome
Timeframe: From 1 year to 2 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Lesion Revascularization (TLR)
|
92 participants
|
SECONDARY outcome
Timeframe: From 2 years to 3 yearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Lesion Revascularization (TLR)
|
104 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Vessel Revascularization (TVR)
|
113 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Vessel Revascularization (TVR)
|
146 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Target Vessel Revascularization (TVR)
|
168 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death and All MI
|
31 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death and All MI
|
51 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death and All MI
|
56 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
87 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
120 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
133 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
|
96 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
|
125 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
|
140 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
122 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
163 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
184 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths and All MI
|
61 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths and All MI
|
105 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths and All MI
|
134 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, All MI and All Revascularization
|
345 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, All MI and All Revascularization
|
449 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, All MI and All Revascularization
|
508 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and TLR
|
126 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and TLR
|
176 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and TLR
|
214 participants
|
SECONDARY outcome
Timeframe: Post Procedure to 1 YearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1948 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and CI-TLR
|
113 participants
|
SECONDARY outcome
Timeframe: From 1 Year to 2 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1921 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and CI-TLR
|
161 participants
|
SECONDARY outcome
Timeframe: From 2 Years to 3 YearsPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
Outcome measures
| Measure |
XIENCE V / PROMUS Stent
n=1890 Participants
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Number of Participants With All Deaths, TVMI and CI-TLR
|
196 participants
|
Adverse Events
XIENCE V / PROMUS Stent
Serious adverse events
| Measure |
XIENCE V / PROMUS Stent
n=2009 participants at risk
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe
|
0.95%
19/2009 • 5 years
|
|
Blood and lymphatic system disorders
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise
|
1.0%
21/2009 • 5 years
|
|
Blood and lymphatic system disorders
Severe/Life Threatening (either intracranial hemorrhage or bleeding that causes hemodynamic compromi
|
0.95%
19/2009 • 5 years
|
|
Cardiac disorders
Abnormal stress test
|
0.45%
9/2009 • 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.90%
18/2009 • 5 years
|
|
Cardiac disorders
Angina-equivalent symptoms
|
5.4%
108/2009 • 5 years
|
|
Cardiac disorders
Arrhythmia of unknown reason
|
0.10%
2/2009 • 5 years
|
|
Cardiac disorders
Atrial arrhythmia
|
0.80%
16/2009 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.35%
7/2009 • 5 years
|
|
Cardiac disorders
Cardiac: other
|
0.15%
3/2009 • 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.15%
3/2009 • 5 years
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.45%
9/2009 • 5 years
|
|
Cardiac disorders
Conduction disorder
|
0.85%
17/2009 • 5 years
|
|
Cardiac disorders
Elevated cardiac enzymes
|
0.20%
4/2009 • 5 years
|
|
Cardiac disorders
Heart failure
|
4.3%
86/2009 • 5 years
|
|
Cardiac disorders
Hypertension
|
0.10%
2/2009 • 5 years
|
|
Cardiac disorders
Hypotension
|
0.15%
3/2009 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.55%
11/2009 • 5 years
|
|
Cardiac disorders
Palpitation
|
0.20%
4/2009 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Restenosis
|
7.9%
158/2009 • 5 years
|
|
Cardiac disorders
Stenosis
|
12.1%
244/2009 • 5 years
|
|
Cardiac disorders
Stent Thrombosis
|
0.30%
6/2009 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.15%
3/2009 • 5 years
|
|
Cardiac disorders
Tamponade
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Valve disorder
|
0.50%
10/2009 • 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.70%
14/2009 • 5 years
|
|
Gastrointestinal disorders
Biliary/liver disorder
|
1.3%
26/2009 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease, diarrhea, nausea
|
1.0%
21/2009 • 5 years
|
|
Gastrointestinal disorders
Other gastro-intestinal symptoms
|
1.4%
28/2009 • 5 years
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.20%
4/2009 • 5 years
|
|
General disorders
Abnormal Lab Test (Non-cardiac):Abnormal CBC with differentials
|
0.20%
4/2009 • 5 years
|
|
General disorders
Abnormal Lab Test (Non-cardiac):Abnormal liver enzymes
|
0.05%
1/2009 • 5 years
|
|
General disorders
Abnormal Lab Test (Non-cardiac):Abnormal other
|
0.25%
5/2009 • 5 years
|
|
General disorders
Contusion
|
0.15%
3/2009 • 5 years
|
|
General disorders
Death of unknown reason
|
1.1%
23/2009 • 5 years
|
|
General disorders
Eye/ear/nose/throat disorder
|
1.1%
23/2009 • 5 years
|
|
General disorders
Fall
|
0.10%
2/2009 • 5 years
|
|
General disorders
Fever
|
0.15%
3/2009 • 5 years
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/2009 • 5 years
|
|
General disorders
General/Musculoskeletal/ Connective: Other
|
1.4%
29/2009 • 5 years
|
|
General disorders
Outcome to Death
|
6.9%
138/2009 • 5 years
|
|
General disorders
Weakness/fatigue
|
0.15%
3/2009 • 5 years
|
|
Immune system disorders
Allergic Reaction to antiplatelet Agent
|
0.05%
1/2009 • 5 years
|
|
Immune system disorders
Allergic Reaction to contrast
|
0.15%
3/2009 • 5 years
|
|
Infections and infestations
Local infection
|
1.3%
26/2009 • 5 years
|
|
Infections and infestations
Systemic infection
|
0.80%
16/2009 • 5 years
|
|
Infections and infestations
Wound infection/abnormal healing
|
0.30%
6/2009 • 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.45%
9/2009 • 5 years
|
|
Metabolism and nutrition disorders
Hyper/hypoglycemia
|
0.05%
1/2009 • 5 years
|
|
Metabolism and nutrition disorders
Thyroid disorder
|
0.10%
2/2009 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Ache/ myalgia/ pain
|
0.15%
3/2009 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone or joint injury/disorder
|
2.1%
42/2009 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Edema
|
0.15%
3/2009 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign
|
0.75%
15/2009 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer and tumour: other
|
0.10%
2/2009 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant
|
5.0%
100/2009 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.35%
7/2009 • 5 years
|
|
Nervous system disorders
Headache/migraine
|
0.05%
1/2009 • 5 years
|
|
Nervous system disorders
Nerve/Psychiatric Disorders : Other
|
0.45%
9/2009 • 5 years
|
|
Nervous system disorders
Neuropathy
|
0.10%
2/2009 • 5 years
|
|
Nervous system disorders
Sleep disorder
|
0.10%
2/2009 • 5 years
|
|
Nervous system disorders
Stroke/CVA
|
1.8%
36/2009 • 5 years
|
|
Nervous system disorders
Syncope/fainting
|
0.40%
8/2009 • 5 years
|
|
Renal and urinary disorders
Genito-urinary and renal disorder
|
2.0%
40/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
2/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.15%
3/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonia
|
0.40%
8/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
4/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
50/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory System: other
|
0.45%
9/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency/failure
|
0.25%
5/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.05%
1/2009 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/Urticaria
|
0.10%
2/2009 • 5 years
|
|
Skin and subcutaneous tissue disorders
skin/subcutaneous disorder: other
|
0.20%
4/2009 • 5 years
|
|
Vascular disorders
Abrupt closure
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Aneurysm
|
0.75%
15/2009 • 5 years
|
|
Vascular disorders
Dissection
|
0.10%
2/2009 • 5 years
|
|
Vascular disorders
Embolism
|
0.20%
4/2009 • 5 years
|
|
Vascular disorders
Hematoma
|
0.35%
7/2009 • 5 years
|
|
Vascular disorders
Ischemia
|
0.50%
10/2009 • 5 years
|
|
Vascular disorders
No/slow reflow
|
0.10%
2/2009 • 5 years
|
|
Vascular disorders
Occlusion
|
0.70%
14/2009 • 5 years
|
|
Vascular disorders
Perforation
|
0.15%
3/2009 • 5 years
|
|
Vascular disorders
Peripheral arterial disease
|
1.7%
35/2009 • 5 years
|
|
Vascular disorders
Peripheral vascular disease (PVD)
|
0.00%
0/2009 • 5 years
|
|
Vascular disorders
Spasm
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Thrombosis - non stent
|
0.30%
6/2009 • 5 years
|
|
Vascular disorders
Vascular: other
|
0.85%
17/2009 • 5 years
|
Other adverse events
| Measure |
XIENCE V / PROMUS Stent
n=2009 participants at risk
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
|
|---|---|
|
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe
|
0.05%
1/2009 • 5 years
|
|
Blood and lymphatic system disorders
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Abnormal stress test
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.15%
3/2009 • 5 years
|
|
Cardiac disorders
Angina-equivalent symptoms
|
1.1%
23/2009 • 5 years
|
|
Cardiac disorders
Arrhythmia of unknown reason
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.30%
6/2009 • 5 years
|
|
Cardiac disorders
Conduction disorder
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Elevated cardiac enzymes
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Heart failure
|
0.30%
6/2009 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
2/2009 • 5 years
|
|
Cardiac disorders
Palpitation
|
0.05%
1/2009 • 5 years
|
|
Cardiac disorders
Restenosis
|
2.2%
44/2009 • 5 years
|
|
Cardiac disorders
Stenosis
|
1.00%
20/2009 • 5 years
|
|
Cardiac disorders
Stent Thrombosis
|
0.10%
2/2009 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.10%
2/2009 • 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.30%
6/2009 • 5 years
|
|
Gastrointestinal disorders
Biliary/liver disorder
|
0.05%
1/2009 • 5 years
|
|
Gastrointestinal disorders
Gastro-intestinal disorder (e.g. GERD, diarrhea, nausea)
|
0.05%
1/2009 • 5 years
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/2009 • 5 years
|
|
General disorders
General/Musculoskeletal/ Connective : Other
|
0.20%
4/2009 • 5 years
|
|
Immune system disorders
Allergic Reaction:To antiplatelet Agent
|
0.05%
1/2009 • 5 years
|
|
Infections and infestations
Wound infection/abnormal healing
|
0.05%
1/2009 • 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
1/2009 • 5 years
|
|
Metabolism and nutrition disorders
Hyper/hypoglycemia
|
0.05%
1/2009 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone or joint injury/disorder
|
0.20%
4/2009 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign
|
0.05%
1/2009 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant
|
0.10%
2/2009 • 5 years
|
|
Nervous system disorders
Nerve/psychiatric disorders : Other
|
0.05%
1/2009 • 5 years
|
|
Renal and urinary disorders
Genito-urinary and renal disorder
|
0.05%
1/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2009 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/Pulmonary disorders : Other
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Dissection
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Ischemia
|
0.20%
4/2009 • 5 years
|
|
Vascular disorders
Jailing of side branch
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
No/slow reflow
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Perforation
|
0.05%
1/2009 • 5 years
|
|
Vascular disorders
Peripheral artery disease (PAD)
|
0.10%
2/2009 • 5 years
|
|
Vascular disorders
Spasm
|
0.10%
2/2009 • 5 years
|
|
Vascular disorders
Thrombosis - non stent
|
0.05%
1/2009 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60