Thomas D Stuckey1, Ajay J Kirtane2, Bruce R Brodie3, Bernhard Witzenbichler4, Claire Litherland5, Giora Weisz6, Michael J Rinaldi7, Franz-Josef Neumann8, D Christopher Metzger9, Timothy D Henry10, David A Cox11, Peter L Duffy12, Ernest L Mazzaferri13, Paul A Gurbel14, Roxana Mehran15, Philippe Généreux16, Ori Ben-Yehuda2, Charles A Simonton17, Gregg W Stone2. 1. LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina. Electronic address: thomas.stuckey@conehealth.com. 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York. 3. LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina. 4. Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany. 5. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 6. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Montefiore Medical Center, Bronx, New York. 7. Sanger Heart & Vascular Institute, Charlotte, North Carolina. 8. Division of Cardiology and Angiology II, Heart Center University of Freiburg, Bad Krozingen, Germany. 9. Wellmont CVA Heart Institute, Kingsport, Tennessee. 10. Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota; Cedars-Sinai Heart Institute, Los Angeles, California. 11. Lehigh Valley Health Network, Allentown, Pennsylvania. 12. Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, North Carolina. 13. The Ohio State University Wexner Medical Center, Columbus, Ohio. 14. Inova Heart and Vascular Institute, Falls Church, Virginia. 15. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 16. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Canada; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. 17. Abbott Vascular, Santa Clara, California.
Abstract
OBJECTIVES: In this analysis of 2-year outcomes in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents) study, the authors sought to examine the independent associations between platelet reactivity to both aspirin and clopidogrel and subsequent outcomes. BACKGROUND: The relationship between platelet reactivity and long-term adverse events following implantation of drug-eluting stents (DES) has been incompletely characterized. METHODS: The ADAPT-DES study was a multicenter registry of patients undergoing routine platelet function testing following percutaneous coronary intervention with DES. The primary study endpoint was definite or probable stent thrombosis (ST); other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. RESULTS: A total of 8,582 patients were enrolled between 2008 and 2010; 46.3% of patients were on dual antiplatelet therapy at 2 years without discontinuation. At 2 years, definite or probable ST occurred in 92 patients (1.07%). In patients treated with dual antiplatelet therapy continuously for 2 years, high platelet reactivity on clopidogrel was independently associated with definite or probable ST (adjusted hazard ratio [HR]: 2.16; 95% confidence interval [CI]: 1.27 to 3.67; p = 0.003), myocardial infarction (adjusted HR: 1.35; 95% CI: 1.05 to 1.74; p = 0.02), freedom from clinically relevant bleeding (adjusted HR: 0.74; 95% CI: 0.62 to 0.90; p = 0.002), and all-cause mortality (adjusted HR: 1.36; 95% CI: 1.01 to 1.85; p = 0.04). Between years 1 and 2, high platelet reactivity was not associated with the very late ST and in patients on aspirin monotherapy, aspirin hyporesponsiveness was not associated with adverse outcomes. CONCLUSIONS: The present study confirms the strong relationship of high platelet reactivity on clopidogrel to 2-year ischemic and bleeding outcomes after DES. The majority of stent-related events occurred within the first year.
OBJECTIVES: In this analysis of 2-year outcomes in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents) study, the authors sought to examine the independent associations between platelet reactivity to both aspirin and clopidogrel and subsequent outcomes. BACKGROUND: The relationship between platelet reactivity and long-term adverse events following implantation of drug-eluting stents (DES) has been incompletely characterized. METHODS: The ADAPT-DES study was a multicenter registry of patients undergoing routine platelet function testing following percutaneous coronary intervention with DES. The primary study endpoint was definite or probable stent thrombosis (ST); other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. RESULTS: A total of 8,582 patients were enrolled between 2008 and 2010; 46.3% of patients were on dual antiplatelet therapy at 2 years without discontinuation. At 2 years, definite or probable ST occurred in 92 patients (1.07%). In patients treated with dual antiplatelet therapy continuously for 2 years, high platelet reactivity on clopidogrel was independently associated with definite or probable ST (adjusted hazard ratio [HR]: 2.16; 95% confidence interval [CI]: 1.27 to 3.67; p = 0.003), myocardial infarction (adjusted HR: 1.35; 95% CI: 1.05 to 1.74; p = 0.02), freedom from clinically relevant bleeding (adjusted HR: 0.74; 95% CI: 0.62 to 0.90; p = 0.002), and all-cause mortality (adjusted HR: 1.36; 95% CI: 1.01 to 1.85; p = 0.04). Between years 1 and 2, high platelet reactivity was not associated with the very late ST and in patients on aspirin monotherapy, aspirinhyporesponsiveness was not associated with adverse outcomes. CONCLUSIONS: The present study confirms the strong relationship of high platelet reactivity on clopidogrel to 2-year ischemic and bleeding outcomes after DES. The majority of stent-related events occurred within the first year.
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