Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)

• Registration Number: NCT00638794
• Lead Sponsor: Cardiovascular Research Foundation, New York

Brief Summary

Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.

Detailed Description

To determine:

1. the frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria,

2. the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and

3. combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-19
• Primary Completion: 2011-12
• Status Verified: 2012-08
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8575

Inclusion Criteria

1. Patients undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated (as defined above) for all lesions (DES + BMS + non-stent).
2. Aspirin use: Adequate aspirin loading given prior to PCI: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg IV aspirin at least 30 minutes prior to the procedure.
3. Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
4. For US sites: Only FDA-approved DES stents may be used in this study. For OUS sites: Only DES stents that are CE marked for approval may be used in this study.
5. PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
6. Patient or guardian able to provide informed written consent.

Exclusion Criteria

1. Patients in whom blood for Accumetrics VerifyNow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and Glycoprotein (GP) IIb/IIIa inhibitor washout duration as follows:

   1. Clopidogrel loading: Clopidogrel loading pre PCI is recommended, but post PCI clopidogrel loading is acceptable per standard of care. In all patients (whether or not clopidogrel is initiated pre or post PCI), prior to blood drawing for VerifyNow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
   2. GP IIb/IIIa inhibitor washout: Eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to VerifyNow platelet function testing. Abciximab must have been discontinued for at 10 days prior to VerifyNow platelet function testing.

2. Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.

3. Severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.

4. Concurrent enrollment in another trial that involves an investigational stent, antithrombotic or antiplatelet agent. Patient in other investigational trials that have not reached their primary endpoint may be enrolled in ADAPT-DES as long as the other trials do not involve an investigational stent, antithrombotic or antiplatelet agent and inclusion of such patient will have no effect on the endpoint of either study.

5. Patients in whom bypass graft surgery is planned within 2 years.

6. Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.

7. Patients unwilling or unable to complete clinical follow-up for the duration of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)	Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications

Primary Outcome Measures

Name	Time	Method
Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.	30 days, 1 year, 2 year

Secondary Outcome Measures

Name	Time	Method
ARC definite, probable, possible or any stent thrombosis, utilizing primary only and then primary + secondary thromboses; death, MI, recurrent ischemia necessitating repeat target lesion and target vessel intervention and MACE.	1 day, 30 days, 1 year, 2 year

Trial Locations

Locations (8)

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

Wellmont Holston Valley Medical Center; 🇺🇸 Kingsport, Tennessee, United States

LeBauer Cardiovascular Research; 🇺🇸 Greensboro, North Carolina, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Columbia University Medical Center & New York Presbyterian; 🇺🇸 New York, New York, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Lehigh Valley Hospital and Health Network; 🇺🇸 Allentown, Pennsylvania, United States

FirstHealth Moore Regional Hospital; 🇺🇸 Pinehurst, North Carolina, United States