Late-Breaking Clinical Trial Abstracts

Abstract

### Late-Breaking Clinical Trials: Risk and Benefit of Dual Antiplatelet Therapy #### Increased Risk of Ischemic Events Upon Discontinuation of Prasugrel After 12 or 30 Months of Therapy Following Placement of the Taxus Liberte Paclitaxel-Eluting Coronary Stent Kirk N Garratt1, Ronald D Jenkins2, Thomas K Pow3, W. Douglas Weaver4, Laura Mauri5, De J Kereiakes6, Kenneth J Winters7, Thomas Christen8, Dominic J Allocco8, David P Lee9; 1Cardiac Interventions, Lenox Hill Heart and Vascular Institute, New York, NY; 2Cardiac Interventions, Heart Clinics Northwest, Coeur d'Alene, ID; 3Cardiac Interventions, Great Lakes Heart Institute, St Joseph, MI; 4Cardiology, Henry Ford Hosp, Detroit, MI; 5Div of Cardiovascular Medicine, Brigham and Women's Hosp, Boston, MA; 6Cardiology, The Christ Hosp Heart and Vascular Cntr/The Lindner Rsch Cntr, Cincinnati, OH; 7Lilly Rsch Laboratories, Eli Lily and Company, Indianapolis, IN; 8Clinical Sciences, Boston Scientific, Marlborough, MA; 9Cardiovascular Medicine Clinic, Standford, Stanford, CA Introduction : The TAXUS Liberte Post-approval Study (TL-PAS) studied long-term clinical outcomes for the TL stent in conjunction with the use of prasugrel and aspirin. A portion of patients from TL-PAS contributed to the Dual Anti-Platelet Therapy (DAPT) trial. Methods : Eligible and consecutive patients in the United States treated with TL stents were enrolled into TL-PAS (N=4199). Those meeting inclusion and exclusion criteria were recruited for participation in the DAPT trial (N=3904). Patients received open-label prasugrel plus aspirin for 12 months after stent placement. At 12 months, patients without ischemic or bleeding events continued aspirin therapy and were randomized 1:1 to continued blinded treatment with either prasugrel or placebo for an additional 18 months (N=2202). At 30 months, study drugs were discontinued, and aspirin was continued through at least 33 months after stent placement. Events were adjudicated by a clinical events committee and monitored by the TL-PAS Data Monitoring Committee (DMC). Results : Nearly 3 years following randomization, the DMC noted a significant increase …