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XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

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ClinicalTrials.gov Identifier: NCT01086228
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Angina
Chronic Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Intervention Device: XIENCE V / PROMUS stent
Enrollment 2010
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description

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.

Period Title: 8 Month Follow-up
Started 2009 [1]
Completed 1938
Not Completed 71
[1]
Analysis population
Period Title: 1-year Follow-up
Started 1938
Completed 1894
Not Completed 44
Period Title: 2-year Follow-up
Started 1894
Completed 1834
Not Completed 60
Period Title: 3-year Follow-up
Started 1834
Completed 1767
Not Completed 67
Period Title: 4-year Follow-up
Started 1767
Completed 1664
Not Completed 103
Period Title: 5-year Follow-up
Started 1664
Completed 1012
Not Completed 652
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 2009
Hide Baseline Analysis Population Description
Baseline characteristics were analyzed for 2,009 patients (XIENCE V:1,159 ; PROMUS : 850).
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2009 participants
70.0  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2009 participants
Female
481
  23.9%
Male
1528
  76.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 2009 participants
2009
1.Primary Outcome
Title Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Hide Description

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

Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2009
Measure Type: Number
Unit of Measure: participants
Definite Stent Thrombosis 6
Probable Stent Thrombosis 2
Possible Stent Thrombosis 6
2.Primary Outcome
Title Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Hide Description

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

Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1894
Measure Type: Number
Unit of Measure: participants
Definite Stent Thrombosis 0
Probable Stent Thrombosis 0
Possible Stent Thrombosis 5
3.Primary Outcome
Title Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Hide Description

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

Time Frame From 2 years to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1834
Measure Type: Number
Unit of Measure: participants
Definite Stent Thrombosis 0
Probable Stent Thrombosis 0
Possible Stent Thrombosis 4
4.Secondary Outcome
Title Number of Participants With Adverse Events Related to Anti-platelet Medication
Hide Description [Not Specified]
Time Frame From post-procedure to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2009
Measure Type: Number
Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test 13
Allergic Reaction 10
Bleeding 32
Cardiac 3
Cancer/Tumor 0
Gastro-intestinal 4
General/Musculoskeletal/Connective 7
Genito-urinary and renal disorder 0
Neurological/Psychiatric disorders 3
Vascular 4
5.Secondary Outcome
Title Number of Participants With Adverse Events Related to Anti-platelet Medication
Hide Description [Not Specified]
Time Frame From 1 year to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1894
Measure Type: Number
Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test 2
Allergic Reaction 0
Bleeding 5
Cardiac 0
Cancer/Tumor 1
Gastro-intestinal 0
General/Musculoskeletal/Connective 0
Genito-urinary and renal disorder 1
Neurological/Psychiatric disorders 0
Vascular 0
6.Secondary Outcome
Title Number of Participants With Adverse Events Related to Anti-platelet Medication
Hide Description [Not Specified]
Time Frame From 2 years to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1834
Measure Type: Number
Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test 2
Allergic Reaction 0
Bleeding 3
Cardiac 1
Cancer/Tumor 0
Gastro-intestinal 0
General/Musculoskeletal/Connective 0
Genito-urinary and renal disorder 0
Neurological/Psychiatric disorders 1
Vascular 0
7.Secondary Outcome
Title Number of Participants With Adverse Events Related to Anti-platelet Medication
Hide Description [Not Specified]
Time Frame From 3 years to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1767
Measure Type: Number
Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test 0
Allergic Reaction 0
Bleeding 9
Cardiac 0
Cancer/Tumor 0
Gastro-intestinal 0
General/Musculoskeletal/Connective 1
Genito-urinary and renal disorder 0
Neurological/Psychiatric disorders 1
Vascular 2
8.Secondary Outcome
Title Number of Participants With Adverse Events Related to Anti-platelet Medication
Hide Description [Not Specified]
Time Frame From 4 years to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1664
Measure Type: Number
Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test 0
Allergic Reaction 0
Bleeding 3
Cardiac 0
Cancer/Tumor 0
Gastro-intestinal 2
General/Musculoskeletal/Connective 2
Genito-urinary and renal disorder 1
Neurological/Psychiatric disorders 1
Vascular 0
9.Secondary Outcome
Title Percent Diameter Stenosis (%DS)
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1548
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1850
Mean (Standard Deviation)
Unit of Measure: Percent Diameter stenosis
69.6  (15.4)
10.Secondary Outcome
Title Percent Diameter Stenosis (%DS)
Hide Description 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).
Time Frame On day 0 after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1548
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1850
Mean (Standard Deviation)
Unit of Measure: Percent Diameter stenosis
23.6  (10.7)
11.Secondary Outcome
Title Percent Diameter Stenosis (%DS)
Hide Description 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).
Time Frame At 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1085
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1309
Mean (Standard Deviation)
Unit of Measure: Percent Diameter stenosis
26.1  (14.5)
12.Secondary Outcome
Title Acute Gain
Hide Description The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time Frame On day 0 after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1548
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1850
Mean (95% Confidence Interval)
Unit of Measure: millimeters
In-stent (n=1845 lesions)
1.769
(1.744 to 1.794)
In-segment (n=1846 lesions)
1.409
(1.383 to 1.436)
13.Secondary Outcome
Title Late Loss
Hide Description Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].
Time Frame On day 0 after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1548
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1850
Mean (95% Confidence Interval)
Unit of Measure: millimeters
In-stent (n=1303 lesions)
0.219
(0.196 to 0.243)
Proximal (n=1086 lesions)
0.152
(0.125 to 0.178)
Distal (n=1298 lesions)
0.034
(0.012 to 0.055)
In-segment (n=1308 lesions)
0.128
(0.099 to 0.157)
14.Secondary Outcome
Title Net Gain
Hide Description Net Gain = Acute Gain - Late Loss, paired analysis only.
Time Frame On day 0 after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1548
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
1850
Mean (95% Confidence Interval)
Unit of Measure: millimeters
In-stent (n=1300 lesions)
1.536
(1.504 to 1.568)
In-segment (n=1305 lesions)
1.269
(1.235 to 1.302)
15.Secondary Outcome
Title Acute Success
Hide Description

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.
Time Frame On day 0 (Immediately post-index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2009
Overall Number of Units Analyzed
Type of Units Analyzed: Stents
3104
Measure Type: Number
Unit of Measure: percentage of stents
Success 99.94
Unknown 0.06
16.Secondary Outcome
Title Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Hide Description

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.

Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
47
17.Secondary Outcome
Title Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Hide Description

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.

Time Frame From 1 to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
80
18.Secondary Outcome
Title Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Hide Description

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.

Time Frame From 2 years to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
109
19.Secondary Outcome
Title Number of Participants With Myocardial Infarctions (MI)
Hide Description

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.

Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
17
20.Secondary Outcome
Title Number of Participants With Myocardial Infarctions (MI)
Hide Description

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.

Time Frame From 1 year to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
30
21.Secondary Outcome
Title Number of Participants With Myocardial Infarctions (MI)
Hide Description

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.

Time Frame From 2 years to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
33
22.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description

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.

Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
72
23.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description

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.

Time Frame From 1 year to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
92
24.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description

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.

Time Frame From 2 years to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
104
25.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description 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.
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
113
26.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description 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.
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
146
27.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description 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.
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
168
28.Secondary Outcome
Title Number of Participants With Cardiac Death and All MI
Hide Description

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.

Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
31
29.Secondary Outcome
Title Number of Participants With Cardiac Death and All MI
Hide Description

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.

Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
51
30.Secondary Outcome
Title Number of Participants With Cardiac Death and All MI
Hide Description

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.

Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
56
31.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
87
32.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
120
33.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
133
34.Secondary Outcome
Title Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
96
35.Secondary Outcome
Title Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
125
36.Secondary Outcome
Title Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
140
37.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
122
38.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
163
39.Secondary Outcome
Title Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
184
40.Secondary Outcome
Title Number of Participants With All Deaths and All MI
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
61
41.Secondary Outcome
Title Number of Participants With All Deaths and All MI
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
105
42.Secondary Outcome
Title Number of Participants With All Deaths and All MI
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
134
43.Secondary Outcome
Title Number of Participants With All Deaths, All MI and All Revascularization
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
345
44.Secondary Outcome
Title Number of Participants With All Deaths, All MI and All Revascularization
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
449
45.Secondary Outcome
Title Number of Participants With All Deaths, All MI and All Revascularization
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
508
46.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and TLR
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
126
47.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and TLR
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
176
48.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and TLR
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
214
49.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and CI-TLR
Hide Description [Not Specified]
Time Frame Post Procedure to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1948
Measure Type: Number
Unit of Measure: participants
113
50.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and CI-TLR
Hide Description [Not Specified]
Time Frame From 1 Year to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1921
Measure Type: Number
Unit of Measure: participants
161
51.Secondary Outcome
Title Number of Participants With All Deaths, TVMI and CI-TLR
Hide Description [Not Specified]
Time Frame From 2 Years to 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1890
Measure Type: Number
Unit of Measure: participants
196
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XIENCE V / PROMUS Stent
Hide Arm/Group Description

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.

All-Cause Mortality
XIENCE V / PROMUS Stent
Affected / at Risk (%)
Total   184/2009 (9.16%) 
Hide Serious Adverse Events
XIENCE V / PROMUS Stent
Affected / at Risk (%)
Total   910/2009 (45.30%) 
Blood and lymphatic system disorders   
Mild: bleeding that is not moderate nor severe  1  19/2009 (0.95%) 
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise  1  21/2009 (1.05%) 
Severe/Life Threatening (either intracranial hemorrhage or bleeding that causes hemodynamic compromi  1  19/2009 (0.95%) 
Cardiac disorders   
Abnormal stress test  1  9/2009 (0.45%) 
Acute coronary syndrome  1  18/2009 (0.90%) 
Angina-equivalent symptoms  1  108/2009 (5.38%) 
Arrhythmia of unknown reason  1  2/2009 (0.10%) 
Atrial arrhythmia  1  16/2009 (0.80%) 
Cardiac arrest  1  7/2009 (0.35%) 
Cardiac: other  1  3/2009 (0.15%) 
Cardiomyopathy  1  3/2009 (0.15%) 
Cardiopulmonary arrest  1  9/2009 (0.45%) 
Conduction disorder  1  17/2009 (0.85%) 
Elevated cardiac enzymes  1  4/2009 (0.20%) 
Heart failure  1  86/2009 (4.28%) 
Hypertension  1  2/2009 (0.10%) 
Hypotension  1  3/2009 (0.15%) 
Myocardial infarction  1  11/2009 (0.55%) 
Palpitation  1  4/2009 (0.20%) 
Pericardial effusion  1  1/2009 (0.05%) 
Restenosis  1  158/2009 (7.86%) 
Stenosis  1  244/2009 (12.15%) 
Stent Thrombosis  1  6/2009 (0.30%) 
Tachycardia  1  3/2009 (0.15%) 
Tamponade  1  1/2009 (0.05%) 
Valve disorder  1  10/2009 (0.50%) 
Ventricular arrhythmia  1  14/2009 (0.70%) 
Gastrointestinal disorders   
Biliary/liver disorder  1  26/2009 (1.29%) 
Gastroesophageal reflux disease, diarrhea, nausea  1  21/2009 (1.05%) 
Other gastro-intestinal symptoms  1  28/2009 (1.39%) 
Pancreatic disorder  1  4/2009 (0.20%) 
General disorders   
Abnormal Lab Test (Non-cardiac):Abnormal CBC with differentials  1  4/2009 (0.20%) 
Abnormal Lab Test (Non-cardiac):Abnormal liver enzymes  1  1/2009 (0.05%) 
Abnormal Lab Test (Non-cardiac):Abnormal other  1  5/2009 (0.25%) 
Contusion  1  3/2009 (0.15%) 
Death of unknown reason  1  23/2009 (1.14%) 
Eye/ear/nose/throat disorder  1  23/2009 (1.14%) 
Fall  1  2/2009 (0.10%) 
Fever  1  3/2009 (0.15%) 
Non cardiac chest pain  1  0/2009 (0.00%) 
General/Musculoskeletal/ Connective: Other  1  29/2009 (1.44%) 
Outcome to Death  1  138/2009 (6.87%) 
Weakness/fatigue  1  3/2009 (0.15%) 
Immune system disorders   
Allergic Reaction to antiplatelet Agent  1  1/2009 (0.05%) 
Allergic Reaction to contrast  1  3/2009 (0.15%) 
Infections and infestations   
Local infection  1  26/2009 (1.29%) 
Systemic infection  1  16/2009 (0.80%) 
Wound infection/abnormal healing  1  6/2009 (0.30%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  9/2009 (0.45%) 
Hyper/hypoglycemia  1  1/2009 (0.05%) 
Thyroid disorder  1  2/2009 (0.10%) 
Musculoskeletal and connective tissue disorders   
Ache/ myalgia/ pain  1  3/2009 (0.15%) 
Bone or joint injury/disorder  1  42/2009 (2.09%) 
Edema  1  3/2009 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign  1  15/2009 (0.75%) 
Cancer and tumour: other  1  2/2009 (0.10%) 
Malignant  1  100/2009 (4.98%) 
Nervous system disorders   
Dizziness  1  7/2009 (0.35%) 
Headache/migraine  1  1/2009 (0.05%) 
Nerve/Psychiatric Disorders : Other  1  9/2009 (0.45%) 
Neuropathy  1  2/2009 (0.10%) 
Sleep disorder  1  2/2009 (0.10%) 
Stroke/CVA  1  36/2009 (1.79%) 
Syncope/fainting  1  8/2009 (0.40%) 
Renal and urinary disorders   
Genito-urinary and renal disorder  1  40/2009 (1.99%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  2/2009 (0.10%) 
Chronic Obstructive Pulmonary Disease (COPD)  1  3/2009 (0.15%) 
Interstitial pneumonia  1  8/2009 (0.40%) 
Pleural effusion  1  4/2009 (0.20%) 
Pneumonia  1  50/2009 (2.49%) 
Respiratory System: other  1  9/2009 (0.45%) 
Respiratory insufficiency/failure  1  5/2009 (0.25%) 
Upper respiratory tract infection  1  1/2009 (0.05%) 
Skin and subcutaneous tissue disorders   
Rash/Urticaria  1  2/2009 (0.10%) 
skin/subcutaneous disorder: other  1  4/2009 (0.20%) 
Vascular disorders   
Abrupt closure  1  1/2009 (0.05%) 
Aneurysm  1  15/2009 (0.75%) 
Dissection  1  2/2009 (0.10%) 
Embolism  1  4/2009 (0.20%) 
Hematoma  1  7/2009 (0.35%) 
Ischemia  1  10/2009 (0.50%) 
No/slow reflow  1  2/2009 (0.10%) 
Occlusion  1  14/2009 (0.70%) 
Perforation  1  3/2009 (0.15%) 
Peripheral arterial disease  1  35/2009 (1.74%) 
Peripheral vascular disease (PVD)  1  0/2009 (0.00%) 
Spasm  1  1/2009 (0.05%) 
Thrombosis - non stent  1  6/2009 (0.30%) 
Vascular: other  1  17/2009 (0.85%) 
1
Term from vocabulary, Abbott Categories
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
XIENCE V / PROMUS Stent
Affected / at Risk (%)
Total   116/2009 (5.77%) 
Blood and lymphatic system disorders   
Mild: bleeding that is not moderate nor severe  1 [1]  1/2009 (0.05%) 
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise  1 [1]  1/2009 (0.05%) 
Cardiac disorders   
Abnormal stress test  1  1/2009 (0.05%) 
Acute coronary syndrome  1  3/2009 (0.15%) 
Angina-equivalent symptoms  1  23/2009 (1.14%) 
Arrhythmia of unknown reason  1  1/2009 (0.05%) 
Cardiopulmonary arrest  1  6/2009 (0.30%) 
Conduction disorder  1  1/2009 (0.05%) 
Elevated cardiac enzymes  1  1/2009 (0.05%) 
Heart failure  1  6/2009 (0.30%) 
Myocardial infarction  1  2/2009 (0.10%) 
Palpitation  1  1/2009 (0.05%) 
Restenosis  1  44/2009 (2.19%) 
Stenosis  1  20/2009 (1.00%) 
Stent Thrombosis  1  2/2009 (0.10%) 
Tachycardia  1  2/2009 (0.10%) 
Ventricular arrhythmia  1  6/2009 (0.30%) 
Gastrointestinal disorders   
Biliary/liver disorder  1  1/2009 (0.05%) 
Gastro-intestinal disorder (e.g. GERD, diarrhea, nausea)  1  1/2009 (0.05%) 
General disorders   
Non cardiac chest pain  1  0/2009 (0.00%) 
General/Musculoskeletal/ Connective : Other  1 [2]  4/2009 (0.20%) 
Immune system disorders   
Allergic Reaction:To antiplatelet Agent  1 [3]  1/2009 (0.05%) 
Infections and infestations   
Wound infection/abnormal healing  1  1/2009 (0.05%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1 [4]  1/2009 (0.05%) 
Hyper/hypoglycemia  1 [4]  1/2009 (0.05%) 
Musculoskeletal and connective tissue disorders   
Bone or joint injury/disorder  1 [5]  4/2009 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign  1 [6]  1/2009 (0.05%) 
Malignant  1 [6]  2/2009 (0.10%) 
Nervous system disorders   
Nerve/psychiatric disorders : Other  1  1/2009 (0.05%) 
Renal and urinary disorders   
Genito-urinary and renal disorder  1  1/2009 (0.05%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  0/2009 (0.00%) 
Respiratory/Pulmonary disorders : Other  1  1/2009 (0.05%) 
Vascular disorders   
Dissection  1  1/2009 (0.05%) 
Ischemia  1  4/2009 (0.20%) 
Jailing of side branch  1  1/2009 (0.05%) 
No/slow reflow  1  1/2009 (0.05%) 
Perforation  1  1/2009 (0.05%) 
Peripheral artery disease (PAD)  1  2/2009 (0.10%) 
Spasm  1  2/2009 (0.10%) 
Thrombosis - non stent  1  1/2009 (0.05%) 
1
Term from vocabulary, Abbott Categories
Indicates events were collected by systematic assessment
[1]
Bleeding
[2]
Except bone or joint injury/disorder and Non cardiac chest pain.
[3]
Allergic Reaction
[4]
Metabolism/endocrine
[5]
Systemic/musculoskeletal/connective tissue disorder
[6]
Cancer and Tumor
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David R Rutledge
Organization: Abbott Vascular
Phone: (408) 845-3820
EMail: david.rutledge@av.abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01086228    
Other Study ID Numbers: 09-384
First Submitted: March 11, 2010
First Posted: March 15, 2010
Results First Submitted: February 13, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018