XIENCE V: SPIRIT WOMEN Sub-study
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01182428
Collaborator
(none)
455
25
2
33.9
18.2
0.5
Study Details
Study Description
Brief Summary
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
455 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
Study Start Date
:
Sep 1, 2008
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: XIENCE V® / XIENCE PRIME™
|
Device: XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
|
| Active Comparator: CYPHER SELECT
|
Device: CYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
|
Outcome Measures
Primary Outcome Measures
- Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [at 1 year]
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.
- In-stent Late Loss (LL) (Main Secondary Endpoint) [at 270 days]
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
Secondary Outcome Measures
- Clinical Device Success [Intra-operative]
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
- Clinical Procedure Success [Intra-operative]
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.
- Adjudicated Stent Thrombosis (Definite, Probable) [< 1 day (Acute)]
- Adjudicated Stent Thrombosis (Definite, Probable) [1 to 30 days (Sub-Acute)]
- Adjudicated Stent Thrombosis (Definite, Probable) [30 days to 1 year (Late)]
- Adjudicated Stent Thrombosis (Definite, Probable, Possible) [30 days to 1 year (Late)]
- Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). [at 30 days]
- Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. [at 240 days]
- Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. [at 1 year]
- Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [at 30 days]
- Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [at 240 days]
- Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [at 30 days]
- Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [at 240 days]
- Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [at 1 year]
- Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [at 30 days]
- Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [at 240 days]
- Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [at 1 year]
- In-segment Late Loss (LL) [at 270 days]
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
- In-stent Angiographic Binary Restenosis Rates [at 270 days]
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).
- In-segment Angiographic Binary Restenosis Rates [at 270 days]
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).
- In-stent Percent Diameter Stenosis [at 270 days]
- In-segment Percent Diameter Stenosis [at 270 days]
- Adjudicated Revascularization (TLR/TVR/All Revascularizations) [at 30 days]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
- Adjudicated Revascularization (TLR/TVR/All Revascularizations) [at 240 days]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
- Adjudicated Revascularization (TLR/TVR/All Revascularizations) [at 1 year]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
- Aneurysm [at 270 days]
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
- Thrombus [at 270 days]
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
- Persisting Dissection [at 270 days]
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
General Inclusion Criteria:
-
Patient must be female.
-
Patient must be at least 18 years of age.
-
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
-
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
-
Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
-
Patient must agree to undergo all protocol-required follow-up examinations.
-
Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
-
Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
-
Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
-
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
-
Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
-
Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
-
Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
-
Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
-
Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
-
Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hosital Italiano de Buenos Aires - Cardiologia | Buenos Aires | Argentina | 1181 | |
| 2 | Instituto Cardiovascular de Buenos Aires-ICBA | Buenos Aires | Argentina | 1428 | |
| 3 | Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II | Wien | Austria | 1090 | |
| 4 | Heilig Hart Ziekenhuis Roeselare | Roeselare | Belgium | 8800 | |
| 5 | Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia | Sao Paulo | Brazil | 04012-180 | |
| 6 | Rigshospitalet | Copenhagen | Denmark | ||
| 7 | Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud | Massy | France | 91300 | |
| 8 | Kardiologische Klinik Herz- und Diabeteszentrum | Bad Oeynhausen | Germany | 32545 | |
| 9 | Segebergerkliniken | Bad Segeberg | Germany | 23795 | |
| 10 | Technische Universität Dresden, Medizinische Klinik II - Kardiologie | Dresden | Germany | 01307 | |
| 11 | Semmelweis University, Department of Cardiovascular Surgery | Budapest | Hungary | ||
| 12 | Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO | Milano | Italy | 20149 | |
| 13 | Centro Cardiologico Monzino | Milan | Italy | 20138 | |
| 14 | Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena | Modena | Italy | 41100 | |
| 15 | Ospedale Cisanello | Pisa | Italy | 56127 | |
| 16 | Istituto Clinico Humanitas | Rozzano | Italy | 20089 | |
| 17 | Latvian Center of Cardiology, P. Stradina University Hospital | Riga | Latvia | 1002 | |
| 18 | AMC | Amsterdam | Netherlands | 1105 | |
| 19 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | 3430 | |
| 20 | Haukeland university hospital | Bergen | Norway | 5021 | |
| 21 | Institute of Cardiology | Warsaw | Poland | 04-628 | |
| 22 | Hospital General de Alicante | Alicante | Spain | 3010 | |
| 23 | Hospital Universitari Germans Trias i Pujol | Barcelona | Spain | 08916 | |
| 24 | Inselspital Bern, Kardiologie | Bern | Switzerland | 3010 | |
| 25 | Cardiocentro Ticino | Lugano | Switzerland | 6900 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Marie-Claude Morice, Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
- Principal Investigator: Stephan Windecker, University Hospital Bern, Bern, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01182428
Other Study ID Numbers:
- 07-377 sub-study
First Posted:
Aug 16, 2010
Last Update Posted:
Aug 7, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 304 | 151 |
| COMPLETED | 293 | 150 |
| NOT COMPLETED | 11 | 1 |
Baseline Characteristics
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 304 | 151 | 455 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
105
34.5%
|
42
27.8%
|
147
32.3%
|
| >=65 years |
199
65.5%
|
109
72.2%
|
308
67.7%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
68.37
(10.14)
|
69.85
(10.54)
|
68.86
(10.29)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
304
100%
|
151
100%
|
455
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Spain |
24
7.9%
|
13
8.6%
|
37
8.1%
|
| Austria |
3
1%
|
3
2%
|
6
1.3%
|
| Switzerland |
43
14.1%
|
25
16.6%
|
68
14.9%
|
| Italy |
62
20.4%
|
31
20.5%
|
93
20.4%
|
| France |
24
7.9%
|
17
11.3%
|
41
9%
|
| Hungary |
41
13.5%
|
12
7.9%
|
53
11.6%
|
| Argentina |
11
3.6%
|
6
4%
|
17
3.7%
|
| Belgium |
6
2%
|
4
2.6%
|
10
2.2%
|
| Brazil |
5
1.6%
|
1
0.7%
|
6
1.3%
|
| Poland |
12
3.9%
|
3
2%
|
15
3.3%
|
| Denmark |
16
5.3%
|
5
3.3%
|
21
4.6%
|
| Germany |
26
8.6%
|
13
8.6%
|
39
8.6%
|
| Latvia |
16
5.3%
|
11
7.3%
|
27
5.9%
|
| Netherlands |
8
2.6%
|
2
1.3%
|
10
2.2%
|
| Norway |
7
2.3%
|
5
3.3%
|
12
2.6%
|
Outcome Measures
| Title | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
|---|---|
| Description | 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. |
| Time Frame | at 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 293 | 150 |
| Number (95% Confidence Interval) [Percentage of Participants] |
21.5
7.1%
|
22
14.6%
|
| Title | Clinical Device Success |
|---|---|
| Description | Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system. |
| Time Frame | Intra-operative |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Measure Lesions | 427 | 200 |
| Number (95% Confidence Interval) [Percentage of evaluated lesions] |
91.1
|
93.5
|
| Title | Clinical Procedure Success |
|---|---|
| Description | 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. |
| Time Frame | Intra-operative |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
85.2
28%
|
84.1
55.7%
|
| Title | Adjudicated Stent Thrombosis (Definite, Probable) |
|---|---|
| Description | |
| Time Frame | < 1 day (Acute) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
| Title | Adjudicated Stent Thrombosis (Definite, Probable) |
|---|---|
| Description | |
| Time Frame | 1 to 30 days (Sub-Acute) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.0
0%
|
0.66
0.4%
|
| Title | Adjudicated Stent Thrombosis (Definite, Probable) |
|---|---|
| Description | |
| Time Frame | 30 days to 1 year (Late) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. Population change based on follow up timeframe. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 287 | 144 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.0
0%
|
0.69
0.5%
|
| Title | Adjudicated Stent Thrombosis (Definite, Probable, Possible) |
|---|---|
| Description | |
| Time Frame | 30 days to 1 year (Late) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Based on Intent to Treat (ITT) population. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 287 | 144 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.35
0.1%
|
1.39
0.9%
|
| Title | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). |
|---|---|
| Description | |
| Time Frame | at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
11.51
3.8%
|
13.25
8.8%
|
| Title | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |
|---|---|
| Description | |
| Time Frame | at 240 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 300 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
14.67
4.8%
|
14.57
9.6%
|
| Title | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |
|---|---|
| Description | |
| Time Frame | at 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 293 | 150 |
| Number (95% Confidence Interval) [Percentage of Participants] |
18.77
6.2%
|
18.67
12.4%
|
| Title | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
|---|---|
| Description | |
| Time Frame | at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
11.51
3.8%
|
13.25
8.8%
|
| Title | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
|---|---|
| Description | |
| Time Frame | at 240 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 300 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
15.33
5%
|
15.23
10.1%
|
| Title | In-stent Late Loss (LL) (Main Secondary Endpoint) |
|---|---|
| Description | In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up. |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Lesions | 300 | 140 |
| Mean (Standard Deviation) [millimeters] |
0.20
(0.38)
|
0.12
(0.36)
|
| Title | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
|---|---|
| Description | |
| Time Frame | at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
12.17
4%
|
13.91
9.2%
|
| Title | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
|---|---|
| Description | |
| Time Frame | at 240 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 300 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
18.0
5.9%
|
17.88
11.8%
|
| Title | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
|---|---|
| Description | |
| Time Frame | at 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 293 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
27.99
9.2%
|
30
19.9%
|
| Title | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
|---|---|
| Description | |
| Time Frame | at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
11.51
3.8%
|
13.25
8.8%
|
| Title | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
|---|---|
| Description | |
| Time Frame | at 240 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 300 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
12.67
4.2%
|
13.25
8.8%
|
| Title | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
|---|---|
| Description | |
| Time Frame | at 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 293 | 150 |
| Number (95% Confidence Interval) [Percentage of Participants] |
13.99
4.6%
|
15.33
10.2%
|
| Title | In-segment Late Loss (LL) |
|---|---|
| Description | LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Lesions | 299 | 140 |
| Mean (Standard Deviation) [millimeters] |
0.10
(0.41)
|
0.04
(0.37)
|
| Title | In-stent Angiographic Binary Restenosis Rates |
|---|---|
| Description | 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). |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Target Lesion | 314 | 148 |
| Number (95% Confidence Interval) [Percentage of Target Lesions] |
3.2
|
0.7
|
| Title | In-segment Angiographic Binary Restenosis Rates |
|---|---|
| Description | 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). |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Target Lesions | 305 | 144 |
| Number (95% Confidence Interval) [Percentage of target lesions] |
4.3
|
2.1
|
| Title | In-stent Percent Diameter Stenosis |
|---|---|
| Description | |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Target Lesions | 314 | 148 |
| Mean (Standard Deviation) [% diameter stenosis] |
15.77
(14.19)
|
13.62
(11.10)
|
| Title | In-segment Percent Diameter Stenosis |
|---|---|
| Description | |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 227 | 114 |
| Measure Target Lesions | 305 | 144 |
| Mean (Standard Deviation) [% diameter stenosis] |
22.26
(13.45)
|
20.14
(12.63)
|
| Title | Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
|---|---|
| Description | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations |
| Time Frame | at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.66
0.2%
|
1.99
1.3%
|
| Title | Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
|---|---|
| Description | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations |
| Time Frame | at 240 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 300 | 151 |
| Number (95% Confidence Interval) [Percentage of Participants] |
8.0
2.6%
|
5.96
3.9%
|
| Title | Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
|---|---|
| Description | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations |
| Time Frame | at 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 293 | 150 |
| Number (95% Confidence Interval) [Percentage of Participants] |
18.09
6%
|
19.33
12.8%
|
| Title | Aneurysm |
|---|---|
| Description | All subjects with aneurysm of the target lesion up to the 270 day follow-up visit |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Measure Lesions | 318 | 151 |
| Number (95% Confidence Interval) [% of target lesions with aneurysm] |
0.0
|
0.0
|
| Title | Thrombus |
|---|---|
| Description | All subjects with thrombus of the target lesion up to the 270 day follow-up visit |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Measure Lesions | 317 | 151 |
| Number (95% Confidence Interval) [Percentage of evaluated lesions] |
0.3
|
1.3
|
| Title | Persisting Dissection |
|---|---|
| Description | All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit |
| Time Frame | at 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 304 | 151 |
| Measure Lesions | 306 | 145 |
| Number (95% Confidence Interval) [Percentage of evaluated lesions] |
0.0
|
0.0
|
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 120/304 (39.5%) | 61/151 (40.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/297 (0.3%) | 1 | 4/149 (2.7%) | 10 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Acute myocardial infarction | 2/297 (0.7%) | 2 | 0/149 (0%) | 0 |
| Angina pectoris | 38/297 (12.8%) | 44 | 8/149 (5.4%) | 10 |
| Angina unstable | 8/297 (2.7%) | 9 | 2/149 (1.3%) | 2 |
| Arteriosclerosis coronary artery | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Atrial fibrillation | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Atrial flutter | 2/297 (0.7%) | 3 | 0/149 (0%) | 0 |
| Cardiac aneurysm | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Ventricular tachycardia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Cardiac failure | 3/297 (1%) | 3 | 2/149 (1.3%) | 2 |
| Cardiac failure acute | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Cardiac tamponade | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Cardiogenic shock | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Coronary artery disease | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Coronary artery dissection | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Coronary artery stenosis | 5/297 (1.7%) | 5 | 6/149 (4%) | 6 |
| Myocardial infarction | 5/297 (1.7%) | 5 | 3/149 (2%) | 3 |
| Myocardial ischaemia | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Palpitations | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Pericardial effusion | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Tachycardia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Deafness | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Vertigo positional | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Eye disorders | ||||
| Diplopia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diverticulum intestinal haemorrhagic | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Duodenal ulcer | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Gastric ulcer | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Haematochezia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Ileus | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Intestinal obstruction | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Melaena | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Periodontitis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| General disorders | ||||
| Asthenia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Catheter site haematoma | 5/297 (1.7%) | 5 | 1/149 (0.7%) | 1 |
| Catheter site haemorrhage | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Chest discomfort | 2/297 (0.7%) | 5 | 1/149 (0.7%) | 1 |
| Non-cardiac chest pain | 1/297 (0.3%) | 1 | 3/149 (2%) | 3 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Immune system disorders | ||||
| Hypersensitivity | 2/297 (0.7%) | 2 | 0/149 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Cystitis | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Diverticulitis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Localised infection | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Pneumonia | 2/297 (0.7%) | 2 | 0/149 (0%) | 0 |
| Urinary tract infection | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Cardiac procedure complication | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Concussion | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Coronary artery restenosis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Device dislocation | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Femoral neck fracture | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Humerus fracture | 2/297 (0.7%) | 2 | 0/149 (0%) | 0 |
| In-stent arterial restenosis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| In-stent coronary artery restenosis | 5/297 (1.7%) | 5 | 6/149 (4%) | 6 |
| Nephropathy toxic | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Pelvic fracture | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Reperfusion injury | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Spinal fracture | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Subdural haematoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Thrombosis in device | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Investigations | ||||
| Biopsy breast | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Blood creatine phosphokinase increased | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Haemoglobin decreased | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Troponin increased | 3/297 (1%) | 3 | 0/149 (0%) | 0 |
| Cardiac enzymes increased | 2/297 (0.7%) | 2 | 4/149 (2.7%) | 4 |
| Metabolism and nutrition disorders | ||||
| Hypovolaemia | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Exostosis | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Knee deformity | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Pain in extremity | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Brain neoplasm | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Breast neoplasm | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Colon cancer | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Malignant melanoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Malignant neoplasm progression | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Multiple myeloma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Neoplasm malignant | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Small intestine carcinoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Uterine leiomyoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral infarction | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Dizziness | 1/297 (0.3%) | 2 | 0/149 (0%) | 0 |
| Headache | 2/297 (0.7%) | 2 | 1/149 (0.7%) | 1 |
| Hypoaesthesia | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Paresis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Syncope | 1/297 (0.3%) | 1 | 1/149 (0.7%) | 1 |
| Transient ischaemic attack | 0/297 (0%) | 0 | 2/149 (1.3%) | 2 |
| Vascular dementia | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Renal and urinary disorders | ||||
| Renal colic | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Renal failure | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Renal failure acute | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Reproductive system and breast disorders | ||||
| Metrorrhagia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Dyspnoea | 4/297 (1.3%) | 4 | 1/149 (0.7%) | 1 |
| Lung disorder | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Pneumothorax | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Pulmonary embolism | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Pulmonary oedema | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Respiratory failure | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Surgical and medical procedures | ||||
| Arterial stent insertion | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Cardiac pacemaker battery replacement | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Cataract operation | 0/297 (0%) | 0 | 2/149 (1.3%) | 2 |
| Coronary angioplasty | 0/297 (0%) | 0 | 2/149 (1.3%) | 2 |
| Coronary revascularisation | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Hip arthroplasty | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Percutaneous coronary intervention | 5/297 (1.7%) | 5 | 2/149 (1.3%) | 2 |
| Scar excision | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Vascular disorders | ||||
| Aortic aneurysm | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Arterial stenosis limb | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Duodenal ulcer haemorrhage | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Femoral arterial stenosis | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Gastric haemorrhage | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Gastrointestinal haemorrhage | 3/297 (1%) | 3 | 1/149 (0.7%) | 1 |
| Hypertension | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Hypertensive crisis | 0/297 (0%) | 0 | 1/149 (0.7%) | 2 |
| Intermittent claudication | 2/297 (0.7%) | 2 | 0/149 (0%) | 0 |
| Lymphoedema | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Peripheral ischaemia | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Rectal haemorrhage | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Retroperitoneal hematoma | 1/297 (0.3%) | 1 | 0/149 (0%) | 0 |
| Shock haemorrhagic | 0/297 (0%) | 0 | 1/149 (0.7%) | 1 |
| Vascular pseudoaneurysm | 5/297 (1.7%) | 5 | 0/149 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 39/297 (13.1%) | 11/149 (7.4%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 21/297 (7.1%) | 22 | 4/149 (2.7%) | 4 |
| Investigations | ||||
| Cardiac enzymes increased | 18/297 (6.1%) | 18 | 11/149 (7.4%) | 11 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Ellen Travis, Clinical Science |
|---|---|
| Organization | Abbott Vascular |
| Phone | 408-845-3000 |
| Ellen.Travis@av.abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01182428
Other Study ID Numbers:
- 07-377 sub-study
First Posted:
Aug 16, 2010
Last Update Posted:
Aug 7, 2012
Last Verified:
Jul 1, 2012