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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060008 / PAS003 |
| Date Original Protocol Accepted |
06/28/2010
|
| Date Current Protocol Accepted |
01/21/2014
|
| Study Name |
Dual Antiplatelet Study
|
| Device Name |
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the Dual Antiplatlet Study is to evaluate
multiple durations of DAPT following DES implantation to determine the optimal duration. The patients will be randomized to either their DAPT or placebo and followed from 12 months to 30 months post index procedure
|
| Study Population |
This device is indicated for improving luminal diameter for
the treatment of de novo lesions < 28 mm in length in native coronary arteries > 2.5 mm to < 4.0 mm in diameter. Study patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention with TAXUS Liberté stent placement and no contraindications to prolonged dual antiplatlet therapy are eligible to be enrolled in this study. Patients randomized to the control group will receive placebo.
|
| Sample Size |
Up to 4200 patients will be randomized for participation in
DAPT. The sample size is estimated based on the expected follow-up rate.
|
| Key Study Endpoints |
No endpoints are specified for the descriptive analyses of
the DAPT study.
Secondary Endpoints: Stent thrombosis, cardiac death, myocardial infarction, target vessel revascularization, stroke, target vessel failure, and bleeding complication.
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| Follow-up Visits and Length of Follow-up |
60 months post index procedure
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| Interim or Final Data Summary |
| Interim Results |
No results can be shared since this study is being conducted under an IDE.
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| Actual Number of Patients Enrolled |
Overall: 4, 199 subjects
On-label: 1,592 subjects
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| Actual Number of Sites Enrolled |
82 sites
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| Patient Follow-up Rate |
Overall: At three years: 85.8% (3579/4173) On-label: At three years: 86.3% (1370/1588)
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| Final Safety Findings |
The primary endpoint (12-month Cardiac Death or myocardial infarction) was met as the difference of -0.9%, with a 1-sided 95% upper confidence limit of -0.2%, was less (P<0.001) than the pre-specified non-inferiority margin of 1.6%.
The annualized stent thrombosis rate on on-label subjects met the pre-specified performance goal. It was 0.56% between 1 and 2 years (upper 1-sided 95% confidence limit (95% UCL):
0.82%) which was below the 1.0% performance goal (P=0.0025). Between 2 and 3 years, it was
0.51% (1-sided 95% UCL: 0.76%, p<0.001).
The secondary endpoint related to on-label subjects with diabetes also met its performance goal. The 12-month target vessel failure rate of 5.1% (1-sided 95% UCL 6.8%) was less (P<0.001) than the pre-specified non-inferiority performance goal of 12.6%.
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| Study Strengths & Weaknesses |
This study provides longer term (3 years) safety and effectiveness results of the TAXUS Liberté paclitaxel-eluting coronary stent system. This post-approval study contributed subjects to the Dual Antiplatelet Therapy (DAPT) trial, an industry/academic research organization/FDA collaboration with the Harvard Clinical Research Institute. This study supports the safety and effectiveness results of the premarket data on the TAXUS Liberté paclitaxel-eluting coronary stent system.
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| Recommendations for Labeling Changes |
Labeling changes are not recommended since this device is no longer on the market.
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