|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060008 / PAS002 |
| Date Original Protocol Accepted |
10/10/2008
|
| Date Current Protocol Accepted |
09/29/2014
|
| Study Name |
TAXUS Registry
|
| Device Name |
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the TAXUS Liberte-Paclitaxel-Eluting Coronary Stent and prasugrel as part of a dual antiplatelet therapy drug regimen. This is a consecutively-enrolled study with follow-up through 5 years. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy study.
|
| Study Population |
Patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with TAXUS Liberté stent placement and no contraindications to prolonged DAPT.
|
| Sample Size |
Approximately 4,200 consecutive, eligible patients will be enrolled at up to 100 U.S. sites.
Primary Endpoint
Given the non-inferiority margin of 1.6% and a one-sided 5% significance level, 2,363 on-label TAXUS Liberté patients would be required to provide 80% power to test the hypothesis for the primary endpoint.
Secondary Endpoints
A total of 2,100 on-label patients treated with the TAXUS Liberté stent and followed through 3 years post stent index procedure is required. To allow for approximately 3.5% attrition per year, 2,546 on-label patients will be required to provide at least 2,100 on-label patients through 3-year follow-up. This will include 871 patients enrolled in the TAXUS ATLAS Workhorse protocol and 1,675 on-label patients enrolled into the TAXUS Liberté Post Approval Study.
|
| Key Study Endpoints |
The rate of Cardiac Death or Myocardial Infarction (MI) among all on-label patients through 12 months or survive free of Cardiac Death or MI for at least 335 days (Day 365 minus 30 days).
Secondary Endpoints
1. Stent thrombosis (ST) rate, using the historical TAXUS definition in the following populations: overall patient population, TAXUS Liberté on-label population, TAXUS Liberté off-label population.
2. ST rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Revascularization) in the following populations; overall patientpopulation, TAXUS Liberté on-label patient population and off-label patient population.
3. Overall and TAXUS-related MACCE rates (cardiac death, myocardial infarction, target vessel revascularization, stroke).
4. Overall and TAXUS-related cardiac death, MI or stroke rates.
5. Overall and TAXUS-related MACE rates (cardiac death, myocardial infarction, target vessel revascularization).
6. Overall and TAXUS-related cardiac death or MI rates.
7. Overall and TAXUS-related target vessel failure (TVF) rates.
8. Overall and TAXUS-related target vessel revascularization (TVR) rates.
9. Overall and TAXUS-related MI rates.
10. Overall and TAXUS-related cardiac death rates.
11. All cause death rate.
12. Non-cardiac death rate.
13. All death or MI rate.
14. All stroke rate.
15. Rate of bleeding complication will be studied separately for GUSTO classifications severe and moderate as well as for major bleeding (the composite of GUSTO severe + moderate bleeding).
|
| Follow-up Visits and Length of Follow-up |
Patients will be consecutively-enrolled and followed up through a minimum of three years.
Length of Follow-up
All patients will be followed for a minimum of three years. For patients who are unblinded at 30 months, determined to have been randomized to prasugrel (blinded), and subsequently provided with additional prasugrel: the 36-month follow-up visit should be conducted as an office visit. In addition, a 42-month follow-up visit is required for this subset of patients by telephone or office visit.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Overall: 4, 199 subjects
On-label: 1,592 subjects
|
| Actual Number of Sites Enrolled |
82 sites
|
| Patient Follow-up Rate |
Overall: At three years: 85.8% (3579/4173)
On-label: At three years: 86.3% (1370/1588)
|
| Final Safety Findings |
Safety/Effectiveness 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%.
|
| 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.
|
| Recommendations for Labeling Changes |
Labeling changes are not recommended since this device is no longer on the market.
|
