Trial Outcomes & Findings for XIENCE V: SPIRIT WOMEN Sub-study (NCT NCT01182428)
NCT ID: NCT01182428
Last Updated: 2012-08-07
Results Overview
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
455 participants
Primary outcome timeframe
at 1 year
Results posted on
2012-08-07
Participant Flow
Patients were recruited between 30 Sept 2008 and 02 December 2009, from the general female interventional cardiology population who had been admitted for a PCI procedure.
Participant milestones
| Measure |
XIENCE V® / XIENCE PRIME®
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
151
|
|
Overall Study
COMPLETED
|
293
|
150
|
|
Overall Study
NOT COMPLETED
|
11
|
1
|
Reasons for withdrawal
| Measure |
XIENCE V® / XIENCE PRIME®
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
XIENCE V: SPIRIT WOMEN Sub-study
Baseline characteristics by cohort
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
105 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
199 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
308 Participants
n=27 Participants
|
|
Age Continuous
|
68.37 years
STANDARD_DEVIATION 10.14 • n=93 Participants
|
69.85 years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
68.86 years
STANDARD_DEVIATION 10.29 • n=27 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=93 Participants
|
151 Participants
n=4 Participants
|
455 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=93 Participants
|
13 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
43 participants
n=93 Participants
|
25 participants
n=4 Participants
|
68 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
62 participants
n=93 Participants
|
31 participants
n=4 Participants
|
93 participants
n=27 Participants
|
|
Region of Enrollment
France
|
24 participants
n=93 Participants
|
17 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
41 participants
n=93 Participants
|
12 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
11 participants
n=93 Participants
|
6 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=93 Participants
|
3 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
16 participants
n=93 Participants
|
5 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=93 Participants
|
13 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Region of Enrollment
Latvia
|
16 participants
n=93 Participants
|
11 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=93 Participants
|
2 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Norway
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at 1 yearPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=293 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=150 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
|
21.5 Percentage of Participants
Interval 16.94 to 26.65
|
22 Percentage of Participants
Interval 15.65 to 29.49
|
PRIMARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=140 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-stent Late Loss (LL) (Main Secondary Endpoint)
|
0.20 millimeters
Standard Deviation 0.38
|
0.12 millimeters
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Intra-operativePopulation: Based on Intent to Treat (ITT) population.
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=427 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=200 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Clinical Device Success
|
91.1 Percentage of evaluated lesions
Interval 87.99 to 93.63
|
93.5 Percentage of evaluated lesions
Interval 89.14 to 96.49
|
SECONDARY outcome
Timeframe: Intra-operativePopulation: Based on Intent to Treat (ITT) population.
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Clinical Procedure Success
|
85.2 Percentage of Participants
Interval 80.7 to 88.99
|
84.1 Percentage of Participants
Interval 77.28 to 89.54
|
SECONDARY outcome
Timeframe: < 1 day (Acute)Population: Based on Intent to Treat (ITT) population.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Definite, Probable)
|
0.0 Percentage of Participants
Interval 0.0 to 1.21
|
0.0 Percentage of Participants
Interval 0.0 to 2.41
|
SECONDARY outcome
Timeframe: 1 to 30 days (Sub-Acute)Population: Based on Intent to Treat (ITT) population.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Definite, Probable)
|
0.0 Percentage of Participants
Interval 0.0 to 1.21
|
0.66 Percentage of Participants
Interval 0.02 to 3.63
|
SECONDARY outcome
Timeframe: 30 days to 1 year (Late)Population: Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=287 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=144 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Definite, Probable)
|
0.0 Percentage of Participants
Interval 0.0 to 1.28
|
0.69 Percentage of Participants
Interval 0.02 to 3.81
|
SECONDARY outcome
Timeframe: 30 days to 1 year (Late)Population: Based on Intent to Treat (ITT) population.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=287 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=144 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
|
0.35 Percentage of Participants
Interval 0.01 to 1.93
|
1.39 Percentage of Participants
Interval 0.17 to 4.93
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
|
11.51 Percentage of Participants
Interval 8.15 to 15.65
|
13.25 Percentage of Participants
Interval 8.28 to 19.71
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
|
14.67 Percentage of Participants
Interval 10.86 to 19.18
|
14.57 Percentage of Participants
Interval 9.36 to 21.22
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=293 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=150 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
|
18.77 Percentage of Participants
Interval 14.47 to 23.72
|
18.67 Percentage of Participants
Interval 12.78 to 25.84
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
|
11.51 Percentage of Participants
Interval 8.15 to 15.65
|
13.25 Percentage of Participants
Interval 8.28 to 19.71
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
|
15.33 Percentage of Participants
Interval 11.45 to 19.92
|
15.23 Percentage of Participants
Interval 9.91 to 21.97
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
|
12.17 Percentage of Participants
Interval 8.72 to 16.38
|
13.91 Percentage of Participants
Interval 8.82 to 20.47
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
|
18.0 Percentage of Participants
Interval 13.82 to 22.82
|
17.88 Percentage of Participants
Interval 12.13 to 24.94
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=293 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
|
27.99 Percentage of Participants
Interval 22.92 to 33.5
|
30 Percentage of Participants
Interval 22.8 to 38.01
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
|
11.51 Percentage of Participants
Interval 8.15 to 15.65
|
13.25 Percentage of Participants
Interval 8.28 to 19.71
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
|
12.67 Percentage of Participants
Interval 9.12 to 16.97
|
13.25 Percentage of Participants
Interval 8.28 to 19.71
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=293 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=150 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
|
13.99 Percentage of Participants
Interval 10.23 to 18.5
|
15.33 Percentage of Participants
Interval 9.98 to 22.11
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=299 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=140 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-segment Late Loss (LL)
|
0.10 millimeters
Standard Deviation 0.41
|
0.04 millimeters
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=314 Target Lesion
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=148 Target Lesion
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-stent Angiographic Binary Restenosis Rates
|
3.2 Percentage of Target Lesions
Interval 1.54 to 5.78
|
0.7 Percentage of Target Lesions
Interval 0.02 to 3.71
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=305 Target Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=144 Target Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-segment Angiographic Binary Restenosis Rates
|
4.3 Percentage of target lesions
Interval 2.29 to 7.18
|
2.1 Percentage of target lesions
Interval 0.43 to 5.97
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=314 Target Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=148 Target Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-stent Percent Diameter Stenosis
|
15.77 % diameter stenosis
Standard Deviation 14.19
|
13.62 % diameter stenosis
Standard Deviation 11.10
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=305 Target Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=144 Target Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
In-segment Percent Diameter Stenosis
|
22.26 % diameter stenosis
Standard Deviation 13.45
|
20.14 % diameter stenosis
Standard Deviation 12.63
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=304 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
|
0.66 Percentage of Participants
Interval 0.08 to 2.36
|
1.99 Percentage of Participants
Interval 0.41 to 5.7
|
SECONDARY outcome
Timeframe: at 240 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=300 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
|
8.0 Percentage of Participants
Interval 5.19 to 11.67
|
5.96 Percentage of Participants
Interval 2.76 to 11.01
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=293 Participants
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=150 Participants
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
|
18.09 Percentage of Participants
Interval 13.85 to 22.98
|
19.33 Percentage of Participants
Interval 13.35 to 26.57
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=318 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Aneurysm
|
0.0 % of target lesions with aneurysm
Interval 0.0 to 1.15
|
0.0 % of target lesions with aneurysm
Interval 0.0 to 2.41
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=317 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=151 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Thrombus
|
0.3 Percentage of evaluated lesions
Interval 0.01 to 1.74
|
1.3 Percentage of evaluated lesions
Interval 0.16 to 4.7
|
SECONDARY outcome
Timeframe: at 270 daysPopulation: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit
Outcome measures
| Measure |
XIENCE V® / XIENCE PRIME®
n=306 Lesions
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=145 Lesions
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Persisting Dissection
|
0.0 Percentage of evaluated lesions
Interval 0.0 to 1.2
|
0.0 Percentage of evaluated lesions
Interval 0.0 to 2.51
|
Adverse Events
XIENCE V® / XIENCE PRIME®
Serious events: 120 serious events
Other events: 39 other events
Deaths: 0 deaths
CYPHER® SELECT
Serious events: 61 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XIENCE V® / XIENCE PRIME®
n=297 participants at risk；n=304 participants at risk
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=149 participants at risk；n=151 participants at risk
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/297 • Number of events 1 • 1 year
|
2.7%
4/149 • Number of events 10 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
12.8%
38/297 • Number of events 44 • 1 year
|
5.4%
8/149 • Number of events 10 • 1 year
|
|
Cardiac disorders
Angina unstable
|
2.7%
8/297 • Number of events 9 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.67%
2/297 • Number of events 3 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Cardiac aneurysm
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
1.0%
3/297 • Number of events 3 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.7%
5/297 • Number of events 5 • 1 year
|
4.0%
6/149 • Number of events 6 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
5/297 • Number of events 5 • 1 year
|
2.0%
3/149 • Number of events 3 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Eye disorders
Diplopia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haematochezia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Periodontitis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
General disorders
Asthenia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
General disorders
Catheter site haematoma
|
1.7%
5/297 • Number of events 5 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
General disorders
Chest discomfort
|
0.67%
2/297 • Number of events 5 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.34%
1/297 • Number of events 1 • 1 year
|
2.0%
3/149 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Infections and infestations
Cystitis
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Infections and infestations
Localised infection
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Concussion
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
1.7%
5/297 • Number of events 5 • 1 year
|
4.0%
6/149 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Nephropathy toxic
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Reperfusion injury
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Investigations
Biopsy breast
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Investigations
Blood creatine phosphokinase increased
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Investigations
Haemoglobin decreased
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
1.0%
3/297 • Number of events 3 • 1 year
|
0.00%
0/149 • 1 year
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.34%
1/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Nervous system disorders
Headache
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Nervous system disorders
Paresis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Nervous system disorders
Syncope
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/297 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
4/297 • Number of events 4 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/297 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/297 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
1.7%
5/297 • Number of events 5 • 1 year
|
1.3%
2/149 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Scar excision
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Vascular disorders
Duodenal ulcer haemorrhage
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Gastric haemorrhage
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
1.0%
3/297 • Number of events 3 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 2 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
0.67%
2/297 • Number of events 2 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Lymphoedema
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Rectal haemorrhage
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Retroperitoneal hematoma
|
0.34%
1/297 • Number of events 1 • 1 year
|
0.00%
0/149 • 1 year
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/297 • 1 year
|
0.67%
1/149 • Number of events 1 • 1 year
|
|
Vascular disorders
Vascular pseudoaneurysm
|
1.7%
5/297 • Number of events 5 • 1 year
|
0.00%
0/149 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.67%
2/297 • Number of events 2 • 1 year
|
2.7%
4/149 • Number of events 4 • 1 year
|
Other adverse events
| Measure |
XIENCE V® / XIENCE PRIME®
n=297 participants at risk；n=304 participants at risk
Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
CYPHER® SELECT
n=149 participants at risk；n=151 participants at risk
Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
7.1%
21/297 • Number of events 22 • 1 year
|
2.7%
4/149 • Number of events 4 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
6.1%
18/297 • Number of events 18 • 1 year
|
7.4%
11/149 • Number of events 11 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60