Author + information
- Received May 15, 2017
- Accepted May 30, 2017
- Published online August 21, 2017.
- Thomas D. Stuckey, MDa,∗ (, )
- Ajay J. Kirtane, MD, SMb,c,
- Bruce R. Brodie, MDa,
- Bernhard Witzenbichler, MDd,
- Claire Litherland, MSb,
- Giora Weisz, MDb,e,
- Michael J. Rinaldi, MDf,
- Franz-Josef Neumann, MDg,
- D. Christopher Metzger, MDh,
- Timothy D. Henry, MDi,j,
- David A. Cox, MDk,
- Peter L. Duffy, MD, MMMl,
- Ernest L. Mazzaferri Jr., MDm,
- Paul A. Gurbel, MDn,
- Roxana Mehran, MDb,o,
- Philippe Généreux, MDb,p,q,
- Ori Ben-Yehuda, MDb,c,
- Charles A. Simonton, MDr,
- Gregg W. Stone, MDb,c,
- ADAPT-DES Investigators
- aLeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina
- bClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- cCenter for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center/New York–Presbyterian Hospital, New York, New York
- dDepartment of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany
- eMontefiore Medical Center, Bronx, New York
- fSanger Heart & Vascular Institute, Charlotte, North Carolina
- gDivision of Cardiology and Angiology II, Heart Center University of Freiburg, Bad Krozingen, Germany
- hWellmont CVA Heart Institute, Kingsport, Tennessee
- iMinneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
- jCedars-Sinai Heart Institute, Los Angeles, California
- kLehigh Valley Health Network, Allentown, Pennsylvania
- lReid Heart Center, FirstHealth of the Carolinas, Pinehurst, North Carolina
- mThe Ohio State University Wexner Medical Center, Columbus, Ohio
- nInova Heart and Vascular Institute, Falls Church, Virginia
- oThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- pHôpital du Sacré-Coeur de Montréal, Montréal, Canada
- qGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- rAbbott Vascular, Santa Clara, California
- ↵∗Address for correspondence:
Dr. Thomas D. Stuckey, LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, 110 Meadowbrook Terrace, Greensboro, North Carolina 27408.
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.
The ADAPT-DES study was sponsored by the Cardiovascular Research Foundation, with funding provided by Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi Sankyo, Eli Lilly, Volcano, and Accumetrics. Dr. Stuckey has served on the advisory board for and received speaker honoraria from Boston Scientific, Eli Lilly/Daiichi Sankyo, and The Medicines Company. Dr. Kirtane has received institutional research grants to Columbia University from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St. Jude Medical, Vascular Dynamics, and Eli Lilly. Dr. Witzenbichler has served as a consultant for Volcano. Dr. Weisz has served on the medical advisory board for Angioslide, AstraZeneca, Calore, Corindus, Filterless, Medtronic, Medivisor, M.I. Medical Incentives, and Vectorious; and has received research grant support from Angioslide, Corindus, and Mitrazyme. Dr. Rinaldi has served as a consultant for Abbott Vascular, Boston Scientific, and St. Jude Medical. Dr. Metzger has served as a consultant for Abbott Vascular, Cordis, IDEV Technologies, Medtronic, and Volcano; Dr. Henry has served on the scientific advisory board for Abbott Vascular, Boston Scientific, and The Medicines Company; and the steering committee for TRANSLATE study sponsored by Eli Lilly/Daiichi Sankyo. Dr. Cox has served as a consultant for Abbott Vascular, Boston Scientific, Medtronic, and The Medicines Company. Dr. Duffy has served as a speaker/consultant for Volcano/Philips. Dr. Gurbel has served as a consultant for Daiichi Sankyo, Bayer, AstraZeneca, Merck, Medtronic, CSL Behring, Janssen, New Haven Pharmaceuticals, Boehringer Ingelheim, and Haemonetics; has received grant support from the National Institutes of Health, Daiichi Sankyo, CSL Behring, AstraZeneca, Harvard Clinical Research Institute, Haemonetics, Coramed, Merck, Sinnowa, and Duke Clinical Research Institute; has received payment for lectures including service on the Speakers Bureaus of AstraZeneca, Daiichi Sankyo, and Merck; has owned stock or stock options in Merck, Medtronic, and Pfizer; and has received patents in the area of personalized antiplatelet therapy and interventional cardiology. Dr. Mehran has received research grant support from Eli Lilly, AstraZeneca, The Medicines Company, Bristol-Myers Squibb/Sanofi; has served as a consultant for AstraZeneca, Bayer, CSL Behring, Janssen Pharmaceuticals, Merck, Osprey Medical, Watermark Research Partners (modest [<$5,000/year]); has served on the scientific advisory board for Abbott Laboratories, Boston Scientific, Covidien, Janssen Pharmaceuticals, The Medicines Company, and Sanofi; Mt. Sinai School of Medicine (faculty occasionally give lectures at events sponsored by industry, but only if the events are free of any marketing purposes to PlatformQ); and has served on committees and the data safety monitoring board for Forest Laboratories (no payment). Dr. Généreux has received speaker fees from Abbott Vascular and Edwards Lifesciences; has served as a consultant for Cardiovascular Systems and PiCardia; and has received institutional research grant support from Boston Scientific. Dr. Simonton is an employee of Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 15, 2017.
- Accepted May 30, 2017.
- 2017 American College of Cardiology Foundation