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.
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 Type
OBSERVATIONAL
Enrollment
8,575
PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Columbia University Medical Center & New York Presbyterian
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
LeBauer Cardiovascular Research
Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.
Time frame: 30 days, 1 year, 2 year
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.
Time frame: 1 day, 30 days, 1 year, 2 year
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Greensboro, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States