Trial Outcomes & Findings for SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) (NCT NCT00180479)
NCT ID: NCT00180479
Last Updated: 2011-11-23
Results Overview
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
COMPLETED
PHASE3
1002 participants
240 days
2011-11-23
Participant Flow
1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.
Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.
Participant milestones
| Measure |
XIENCE V® EECSS
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Overall Study
STARTED
|
669
|
333
|
|
Overall Study
COMPLETED
|
653
|
320
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
| Measure |
XIENCE V® EECSS
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Informed consent not signed
|
0
|
1
|
Baseline Characteristics
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Baseline characteristics by cohort
| Measure |
XIENCE V® EECSS
n=669 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=333 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
Total
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age Categorical
Between 18 and 65 years
|
376 participants
n=5 Participants
|
191 participants
n=7 Participants
|
567 participants
n=5 Participants
|
|
Age Categorical
>=65 years
|
293 participants
n=5 Participants
|
141 participants
n=7 Participants
|
434 participants
n=5 Participants
|
|
Age Continuous
|
63.23 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
62.80 years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
63.08 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Gender
Female
|
200 participants
n=5 Participants
|
114 participants
n=7 Participants
|
314 participants
n=5 Participants
|
|
Gender
Male
|
469 participants
n=5 Participants
|
218 participants
n=7 Participants
|
687 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
669 participants
n=5 Participants
|
333 participants
n=7 Participants
|
1002 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 240 daysPopulation: Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
Outcome measures
| Measure |
XIENCE V® EECSS
n=301 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=134 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Primary Endpoint: In-segment Late Loss (LL)
|
0.14 millimeters
Standard Deviation 0.41
|
0.28 millimeters
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 270 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for this endpoint.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=657 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=321 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
|
7.2 percentage of participants
|
9.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=667 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=330 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
1.6 percentage of participants
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=664 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=326 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
4.1 percentage of participants
|
5.5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=654 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=319 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
8.6 percentage of participants
|
11.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=637 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
11.3 percentage of participants
|
16.4 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=629 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
14.3 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: 4 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=615 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=302 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
18.5 percentage of participants
|
22.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=667 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=330 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
0.4 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=664 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=326 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
1.5 percentage of participants
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=659 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=320 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
2.7 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=654 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=319 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
3.4 percentage of participants
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=637 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
5.7 percentage of participants
|
9.2 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=629 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
5.7 percentage of participants
|
9.2 percentage of participants
|
SECONDARY outcome
Timeframe: 4 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=615 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=302 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
8.0 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=667 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=330 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
0.3 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=664 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=326 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
1.2 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=659 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=320 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
2.9 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=654 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=319 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
3.1 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=637 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
4.9 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=629 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
6.7 percentage of participants
|
8.9 percentage of participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=615 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=302 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
7.8 percentage of participants
|
9.6 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=667 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=330 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
1.3 percentage of participants
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=664 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=326 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
2.9 percentage of participants
|
5.2 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=659 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=320 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
5.0 percentage of participants
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=654 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=319 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
6.0 percentage of participants
|
10.3 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=637 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event(MACE)
|
7.7 percentage of participants
|
13.8 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=629 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=305 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
9.7 percentage of participants
|
16.4 percentage of participants
|
SECONDARY outcome
Timeframe: 4 yearPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=615 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=302 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
12.8 percentage of participants
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Outcome measures
| Measure |
XIENCE V® EECSS
n=343 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=158 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
In-stent % Angiographic Binary Restenosis (% ABR) Rate
|
2.3 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Outcome measures
| Measure |
XIENCE V® EECSS
n=344 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=158 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
In-segment % Angiographic Binary Restenosis (% ABR) Rate
|
4.7 percentage of participants
|
8.9 percentage of participants
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Incomplete Apposition (Persisting \& Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol \& ARC definition. Persisting dissection @ follow-up, present post-procedure.
Outcome measures
| Measure |
XIENCE V® EECSS
n=90 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=43 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
|
24.4 percentage of participants
|
14.0 percentage of participants
|
SECONDARY outcome
Timeframe: In-hospitalSuccessful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis \< 50%.
Outcome measures
| Measure |
XIENCE V® EECSS
n=763 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=379 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Acute Success: Clinical Device
|
98.3 percentage of participants
|
98.7 percentage of participants
|
SECONDARY outcome
Timeframe: In-hospitalSuccessful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis \< 50%.
Outcome measures
| Measure |
XIENCE V® EECSS
n=661 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=331 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Acute Success: Clinical Procedure
|
98.5 percentage of participants
|
97.3 percentage of participants
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)
Outcome measures
| Measure |
XIENCE V® EECSS
n=293 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=134 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Proximal Late Loss
|
0.12 millimeters
Standard Deviation 0.40
|
0.20 millimeters
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Outcome measures
| Measure |
XIENCE V® EECSS
n=327 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=154 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Distal Late Loss
|
0.09 millimeters
Standard Deviation 0.36
|
0.10 millimeters
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
Outcome measures
| Measure |
XIENCE V® EECSS
n=342 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=158 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
In-stent Late Loss
|
0.16 millimeters
Standard Deviation 0.41
|
0.30 millimeters
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Defined as stent intimal hyperplasia and calculated as 100\*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
Outcome measures
| Measure |
XIENCE V® EECSS
n=98 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=39 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
% Volume Obstruction (% VO)
|
6.91 percent of volume obstruction
Standard Deviation 6.35
|
11.21 percent of volume obstruction
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
In-stent: Within the margins of the stent, the value calculated as 100 \* (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Outcome measures
| Measure |
XIENCE V® EECSS
n=343 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=158 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
In-stent % Diameter Stenosis (% DS)
|
5.92 percent diameter stenosis
Standard Deviation 16.40
|
10.30 percent diameter stenosis
Standard Deviation 21.43
|
SECONDARY outcome
Timeframe: 240 daysPopulation: Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.
Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 \* (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Outcome measures
| Measure |
XIENCE V® EECSS
n=344 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=158 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
In-segment % Diameter Stenosis (% DS)
|
18.77 percent of in-segment diameter stenosis
Standard Deviation 14.43
|
22.82 percent of in-segment diameter stenosis
Standard Deviation 16.35
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death (death in which a cardiac cause cannot be excluded) * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI * Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=605 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=286 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
20.3 percentage of participants
|
26.6 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Outcome measures
| Measure |
XIENCE V® EECSS
n=605 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=286 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
8.9 percentage of participants
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Revascularization at the target vessel associated with any of the following * Positive functional ischemia study * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study Derived from Non-Hierarchical Subject Counts of Adverse Events
Outcome measures
| Measure |
XIENCE V® EECSS
n=605 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=286 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
8.8 percentage of participants
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
The composite endpoint comprised of: * Cardiac death * Myocardial infarction (MI, classified as Q-wave and non-Q wave) * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Outcome measures
| Measure |
XIENCE V® EECSS
n=605 Participants
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
n=286 Participants
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Event (MACE)
|
14.4 percentage of participants
|
22.0 percentage of participants
|
Adverse Events
XIENCE V® EECSS
TAXUS® EXPRESS2™ ECSS
Serious adverse events
| Measure |
XIENCE V® EECSS
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
4/438 • Number of events 4
|
1.4%
3/211 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Infections and infestations
Abscess limb
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Acute coronary syndrome
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
General disorders
Adverse drug reaction
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.23%
1/438 • Number of events 3
|
2.4%
5/211 • Number of events 6
|
|
Cardiac disorders
Angina pectoris
|
9.6%
42/438 • Number of events 51
|
17.5%
37/211 • Number of events 41
|
|
Cardiac disorders
Angina unstable
|
0.91%
4/438 • Number of events 4
|
0.95%
2/211 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
1.4%
6/438 • Number of events 7
|
0.95%
2/211 • Number of events 4
|
|
Vascular disorders
Arterial thrombosis limb
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Arteriogram coronary
|
0.46%
2/438 • Number of events 2
|
0.95%
2/211 • Number of events 2
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Atherectomy
|
0.68%
3/438 • Number of events 3
|
0.95%
2/211 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
2/438 • Number of events 2
|
1.4%
3/211 • Number of events 3
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Blood creatinine increased
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Investigations
Blood glucose increased
|
0.68%
3/438 • Number of events 3
|
0.00%
0/211
|
|
Investigations
Blood pressure decreased
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Body temperature increased
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Bradycardia
|
0.46%
2/438 • Number of events 2
|
0.95%
2/211 • Number of events 2
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Breast lump removal
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
6/438 • Number of events 8
|
2.8%
6/211 • Number of events 7
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Investigations
Cardiac stress test abnormal
|
0.46%
2/438 • Number of events 2
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Cardiorespiratory arrest
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Nervous system disorders
Carotid artery stenosis
|
0.46%
2/438 • Number of events 2
|
0.95%
2/211 • Number of events 2
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
General disorders
Catheter site haematoma
|
0.68%
3/438 • Number of events 3
|
0.95%
2/211 • Number of events 2
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Nervous system disorders
Central nervous system lesion
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
4/438 • Number of events 4
|
0.47%
1/211 • Number of events 2
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
General disorders
Chest discomfort
|
0.46%
2/438 • Number of events 2
|
1.4%
3/211 • Number of events 3
|
|
Cardiac disorders
Chest pain
|
1.1%
5/438 • Number of events 5
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.46%
2/438 • Number of events 3
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Colectomy
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Coronary angioplasty
|
2.1%
9/438 • Number of events 9
|
4.3%
9/211 • Number of events 10
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.68%
3/438 • Number of events 3
|
0.95%
2/211 • Number of events 2
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
2.3%
10/438 • Number of events 28
|
1.4%
3/211 • Number of events 5
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
7/438 • Number of events 7
|
0.00%
0/211
|
|
Cardiac disorders
Coronary artery dissection
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.46%
2/438 • Number of events 2
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Coronary artery stenosis
|
1.6%
7/438 • Number of events 7
|
1.4%
3/211 • Number of events 3
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Coronary revascularisation
|
13.7%
60/438 • Number of events 94
|
20.4%
43/211 • Number of events 68
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Investigations
Dehydration
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Nervous system disorders
Dementia
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
2/438 • Number of events 2
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.46%
2/438 • Number of events 2
|
0.47%
1/211 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.91%
4/438 • Number of events 4
|
0.00%
0/211
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/438 • Number of events 1
|
1.4%
3/211 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
3/438 • Number of events 3
|
0.47%
1/211 • Number of events 1
|
|
General disorders
Fatigue
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Vascular disorders
Femoral arterial stenosis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
1.4%
6/438 • Number of events 6
|
1.9%
4/211 • Number of events 4
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Investigations
Haemoglobin decreased
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Nervous system disorders
Headache
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
General disorders
Hernia obstructive
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.23%
1/438 • Number of events 1
|
1.4%
3/211 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.91%
4/438 • Number of events 4
|
0.95%
2/211 • Number of events 2
|
|
Vascular disorders
Iliact artery stenosis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Instent coronary artery restenosis
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
11/438 • Number of events 11
|
4.7%
10/211 • Number of events 10
|
|
Cardiac disorders
Myocardial ischaemia
|
5.7%
25/438 • Number of events 27
|
5.7%
12/211 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
General disorders
Noncardiac chest pain
|
3.7%
16/438 • Number of events 20
|
5.2%
11/211 • Number of events 14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
General disorders
Pain
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Pancreatitis
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Vascular disorders
Peripheral ischaemia
|
0.91%
4/438 • Number of events 4
|
1.4%
3/211 • Number of events 3
|
|
Vascular disorders
Peripheral vascular disorder
|
0.23%
1/438 • Number of events 1
|
1.4%
3/211 • Number of events 3
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Social circumstances
Physical disability
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Infections and infestations
Pneumonia
|
1.4%
6/438 • Number of events 6
|
0.47%
1/211 • Number of events 1
|
|
Infections and infestations
Pneumonia fungal
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Surgical and medical procedures
Prostatectomy
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Pyrexia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Surgical and medical procedures
Renal artery stent placement
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/438 • Number of events 1
|
0.95%
2/211 • Number of events 4
|
|
Renal and urinary disorders
Renal failure acute
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/438
|
0.47%
1/211 • Number of events 4
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Vascular disorders
Retroperitoneal haemorrhage
|
0.46%
2/438 • Number of events 2
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Sick sinus syndrome
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/438 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Spinal operation
|
0.23%
1/438 • Number of events 1
|
0.95%
2/211 • Number of events 2
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/438
|
0.47%
1/211 • Number of events 2
|
|
Nervous system disorders
Syncope
|
1.1%
5/438 • Number of events 6
|
0.95%
2/211 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Surgical and medical procedures
Thrombectomy
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.23%
1/438 • Number of events 2
|
0.00%
0/211
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Surgical and medical procedures
Thyroidectomy
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Nervous system disorders
Transient ischaemic attack
|
0.68%
3/438 • Number of events 3
|
0.47%
1/211 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/438
|
0.95%
2/211 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Infections and infestations
Urosepsis
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Vascular disorders
Vascular pseudoaneurysm
|
1.1%
5/438 • Number of events 5
|
1.4%
3/211 • Number of events 3
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/438
|
0.47%
1/211 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/438 • Number of events 1
|
0.00%
0/211
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/438 • Number of events 1
|
0.95%
2/211 • Number of events 2
|
Other adverse events
| Measure |
XIENCE V® EECSS
XIENCE V® Everolimus Eluting Coronary Stent System
|
TAXUS® EXPRESS2™ ECSS
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
16.2%
71/438 • Number of events 93
|
16.6%
35/211 • Number of events 44
|
|
General disorders
Catheter site haematoma
|
2.7%
12/438 • Number of events 12
|
5.2%
11/211 • Number of events 11
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
7/438 • Number of events 7
|
5.2%
11/211 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place