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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Dual Antiplatelet Therapy EDUCATE


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General
Application Number P060033 / PAS003
Current Plan Approved 02/01/2008
Study Name Dual Antiplatelet Therapy EDUCATE
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 Design Description This is a prospective, multi-center study designe to further understand Endeavor stent treatment patterns and clinical outcomes in broad, unselected patient populations in North America, and to understand North American physician prescription patterns of dual antiplatelet therapy and implications of compliance with dual antiplatelet therapy.
Study Population Description This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length < 27mm in native coronary arteries with reference vessel diameters of > 2.5mm to < 3.5 mm. Study subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention with stent placement are eligible to be enrolled in this study. Subjects may have multi-vessel treatment. Patients eligible for randomization into the CPI should not have contraindications to prolonged dual antiplatelet therapy noted at the time of randomization.
Sample Size A minimum of 2,000 patients and a maximum of 4,000 patients, 100-150 sites
Data Collection Endpoints that will be analyzed include: 1) definite and probable stent thrombosis at one year; 2) Combined rate of cardiac death and MI at one year; 3) Composite of death, target vessel MI, stroke, and major bleeding (severe or moderate per GUSTO classification) at one year; and 4) dual antiplatlet therapy compliance rates at each follow up interval to one year.
Follow-up Visits and Length of Follow-up Patients will be followed at 3 , 6, 9, 12, 15, 18, 24, 30, and 33 months. The 12 month and 30 month follow-up include a clincal visit, 6, 9, 15, 18, 24, and 33 month follow-up involves telephone follow-up.
Final Study Results
Interim Safety Information No results can be shared since this study is being conducted under an IDE.
Number of Patients 2262 patients were enrolled and followed from baseline. Of those enrolled, 1,440 patients were considered 12 months clear, (defined as thienopyridine compliant with no event prior to the 12 month time point) and from those, 811 provided consent to be randomized into the Critical Path Initiative (CPI) portion of the study and followed through 33 months.
Number of Sites A total of 92 sites were included in this study.
Follow-up Rate At 12 months, the follow-up rate was 87.9%. For the non-randomized group at 24 months, the follow- up rate was 99.6%. Finally, the CPI follow-up rate at 33 months was 99.7%.
Safety Findings At one year, the Academic Research Consortium (ARC)-defined definite/probable stent thrombosis rate

was 1.3%. The combined rate of cardiac death and myocardial infarction (MI) at one year was 3.8%. The rate of the composite endpoint, including death, target vessel MI, stroke, and major bleeding (severe or moderate per GUSTO classification) at one year was 7.4%.



The rates for all key endpoints including ARC definite/probable stent thrombosis, cardiac death/MI, and the composite endpoint (death, target vessel MI, stroke, and major bleeding) were consistently low (below 10%) across all groups except for the rate of the composite endpoint among the non- randomized subjects followed to 24 months. Results of this composite endpoint for all groups beyond

12 months are as follows: Non-Randomized at 24 months: 16.9%, CPI Intent-to-Treat (ITT) 12 months Dual Antiplatelet Therapy (DAPT): 5.9%, CPI ITT 30 months DAPT: 5.9%, CPI on-treatment (OT) 12 months DAPT: 1.7%, and CPI OT 30 months DAPT: 4.8%. The rates of cardiac death/MI and thrombosis were similar between the 12 month DAPT group and the 30 month DAPT group at 33 months.

Although not tested for significance, patients considered ┬┐complex┬┐ had higher rates of ARC definite/probable stent thrombosis, cardiac death/MI and the composite endpoint in comparison to non-complex patients.
Effect Findings Rates of DAPT usage and compliance were as expected and per protocol, indicating use of placebo or thienopyridine in the randomized (CPI) portion of the study. DAPT compliance rates were 88.3% on the day of procedure, 98.1% at 30 days, 96.2% at 180 days, and 93.5% at one year.



The increased rate of DAPT use in the CPI ITT 12 month DAPT group (5.85%) and the decreased rate of DAPT use in the CPI ITT 30 month DAPT group (80.7%) may represent the management of events that occurred during this phase as well as subject medication use. On-treatment rates were as expected, however, with only 1.3% using DAPT among the 12 months DAPT group at 30 months, and 99.6% among the 30 month DAPT group at 30 months.

Strengths & Weaknesses The study observed clinical outcomes in a broad unselected patient population during one year, and up to 33 months in randomized subjects following PCI treatment to help define optimal duration of DAPT therapy. It also provides a background for future studies and analyses that will better and more definitively define optimal duration of DAPT therapy.

Limitations to this study may include the omission of subjects who had an event prior to one year, as

they are at most risk for subsequent complications from infarction or bleeding; as few, if any, studies are adequately powered to identify optimal DAPT duration, the omission is reasonable. This study was not powered to determine a treatment effect on clinical outcomes of different durations of DAPT treatment

Label Changes A labeling update is not needed because Medtronic Vascular has ceased manufacturing and distribution of the Endeavor Spring OTW and RX devices.


Dual Antiplatelet Therapy EDUCATE Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/01/2008 08/04/2008 Overdue/Received
12 month report 01/26/2009 01/26/2009 On Time
18 month report 07/26/2009 07/23/2009 On Time
2 year report 01/14/2010 01/14/2010 On Time
3 year report 01/31/2011 01/31/2011 On Time
4 year report 01/31/2012 01/30/2012 On Time
5 year report 01/30/2013 01/30/2013 On Time
6 year report 01/30/2014 01/30/2014 On Time
final report 12/31/2014 12/19/2014 On Time
revised final report 11/20/2015 11/20/2015 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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