Author + information
- Received September 15, 2015
- Revision received September 29, 2015
- Accepted October 1, 2015
- Published online January 25, 2016.
- James B. Hermiller, MD∗,
- Mitchell W. Krucoff, MD†,
- Dean J. Kereiakes, MD‡,
- Stephan Windecker, MD§,
- P. Gabriel Steg, MD‖,¶,
- Robert W. Yeh, MD, MSc#∗∗,††,
- David J. Cohen, MD, MSc‡‡,
- Donald E. Cutlip, MD∗∗,††,§§,
- Joseph M. Massaro, PhD††,‖‖,
- Wen-Hua Hsieh, PhD††,
- Laura Mauri, MD, MSc∗∗,††,¶¶∗ (, )
- DAPT Study Investigators
- ∗St. Vincent Heart Center, Indianapolis, Indiana
- †Department of Medicine, Duke University Medical Center, Durham, North Carolina
- ‡The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio
- §Department of Cardiology, Bern University Hospital, Bern, Switzerland
- ‖Université Paris-Diderot, INSERM U-1148, and Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France
- ¶National Heart & Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom
- #The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ∗∗Harvard Medical School, Boston, Massachusetts
- ††Harvard Clinical Research Institute, Boston, Massachusetts
- ‡‡Department of Cardiology, Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City School of Medicine, Kansas City, Missouri
- §§Department of Medicine, Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ‖‖School of Public Health, Boston University School of Medicine, Boston, Massachusetts
- ¶¶Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Laura Mauri, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115.
Objectives The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)–treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting.
Background In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study.
Methods The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc.
Results Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01).
Conclusions In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938)
This study was sponsored by the Harvard Clinical Research Institute. Funding for this study was provided by Abbott Vascular, Boston Scientific, Cordis Corporation, Medtronic, Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership, Eli Lilly and Company, Daiichi Sankyo Company Limited, and the U.S. Department of Health and Human Services (1RO1FD003870-01). Dr. Hermiller is a consultant for Abbott Vascular, Boston Scientific, Medtronic, and St. Jude Medical. Dr. Krucoff is a consultant for and has received grants from Abbott Vascular, Medtronic, Boston Scientific, OrbusNeich, and Biosensors. Dr. Windecker has received research funding (to his institution) from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Biosensors, Medtronic, The Medicines Company, and St. Jude Medical; and has received speakers fees from AstraZeneca, Eli Lilly and Company, Abbott, Biotronik, Boston Scientific, Biosensors, Medtronic, and Bayer. Dr. Steg has received research funding from Sanofi and Servier; is a consultant for Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL-Behring, Daiichi-Sankyo-Lilly, GlaxoSmithKline, Janssen, Medtronic, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company; and is a stockholder in Aterovax. Dr. Yeh is on an advisory board of Abbott Vascular; and is a consultant for Gilead Sciences, Boston Scientific, and Merck. Dr. Cohen receives research grant support from Eli Lilly, AstraZeneca, Daiichi-Sankyo, Medtronic, Abbott Vascular, and Boston Scientific; is a consultant for Eli Lilly, AstraZeneca, Medtronic, and Abbott Vascular; and receives speaking honoraria from AstraZeneca. Dr. Cutlip received research funding (paid to his institution) from Medtronic, Boston Scientific, and Celonova. Dr. Massaro has received funding from Harvard Clinical Research Institute for statistical services for the paper. Dr. Mauri has received grants (to her institution) from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly and Company, Daiichi-Sankyo, Sanofi, Bristol-Myers Squibb, Boehringer Ingelheim, and Biotronik; is a consultant for Amgen, Medtronic, Eli Lilly and Company, Boehringer Ingelheim, Recor, and Biotronik; and has received honoraria from AstraZeneca and Sanofi. Drs. Kereiakes and Hsieh have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 15, 2015.
- Revision received September 29, 2015.
- Accepted October 1, 2015.
- American College of Cardiology Foundation