Study concept and design: Kereiakes, Yeh, Massaro, Cutlip, Mauri.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Kereiakes, Yeh, Mauri.
Critical revision of the manuscript for important intellectual content: Kereiakes, Yeh, Massaro, Driscoll-Shempp, Cutlip, Steg, Gershlick, Darius, Meredith, Ormiston, Tanguay, Windecker, Garratt, Kandzari, Lee, Simon, Iancu, Trebacz, Mauri.
Statistical analysis: Massaro, Mauri.
Obtained funding: Mauri.
Administrative, technical, or material support: Driscoll-Shempp, Cutlip, Mauri.
Study supervision: Driscoll-Shempp, Mauri.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Yeh reported having received personal fees from Abbott Vascular, personal fees and nonfinancial support from Harvard Clinical Research Institute, and personal fees from Gilead Sciences. Dr Massaro reported having received personal fees from Harvard Clinical Research Institute. Dr Cutlip reported having received support from Medtronic, Boston Scientific, Cordis, and Abbott Vascular and grants from the National Heart, Lung, and Blood Institute. Dr Steg reported having received personal fees from Amarin, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck-Sharpe-Dohme, Novartis, Otsuka, Pfizer, Roche, Medtronic, Vivus, The Medicines Company, and Orexigen and grants and personal fees from sanofi-aventis and Servier. Dr Gershlick reported having received personal fees from Medtronic and Abbott and grants from The Medicines Company. Dr Darius reported having received grants from Harvard Clinical Research Institute. Dr Meredith reported having received support from Boston Scientific and Medtronic. Dr Tanguay reported having received personal fees and/or other support from Abbott Vascular, AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Roche, sanofi-aventis, Servier, Ikaria, and Merck. Dr Windecker reported having received grants from St Jude Medical, Biotronik, The Medicines Company, Abbott, Medtronic, and Edwards Lifesciences and personal fees from AstraZeneca, Eli Lilly, Abbott, Biosensors, Biotronik, and Bayer. Dr Garratt reported having received grants from Boston Scientific, Abbott Vascular, and CeloNova and personal fees or other support from Boston Scientific, The Medicines Company, Abbott Vascular, Infarct Reduction Technologies, Guided Delivery Systems, and Daiichi-Sankyo/Lilly. Dr Kandzari reported having received grants from Medtronic CardioVascular, Abbott Vascular, Boston Scientific, and Biotronik and personal fees from Micell Technologies, Medtronic CardioVascular, and Boston Scientific. Dr Lee reported having received grants from Boston Scientific and personal fees from Boston Scientific and Medtronic. Dr Simon reported having received other support from Cordis/Johnson & Johnson and personal fees from Cordis/Johnson & Johnson and Medtronic Vascular. Dr Mauri reported having received grants from Abbott, Boston Scientific, Medtronic, Cordis, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb, sanofi-aventis, and Biotronik and personal fees from Medtronic, St Jude, and Biotronik. No other disclosures were reported.
Funding/Support: The study was sponsored by the Harvard Clinical Research Institute (HCRI) and funded by Abbott, Boston Scientific, Cordis, Medtronic, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, Eli Lilly, and Daiichi Sankyo and the US Department of Health and Human Services (1RO1FD003870-01).
Role of the Funder/Sponsor: The funding manufacturers and US Food and Drug Administration had input on the study design and conduct of the study. The HCRI oversaw the collection, management, and analysis of the data; the study authors were responsible for interpretation of the data, preparation of the manuscript, and the decision to submit the manuscript for publication.
Previous Presentation: Results were presented in an abstract and in a presentation at the American Heart Association Scientific Sessions; Chicago, Illinois; November 18, 2014.
Additional Contributions: We thank the other investigators, the staff, and the participants of the DAPT Study for their valuable contributions. We wish to acknowledge Joanna Suomi, MSc, for assistance editing and formatting the manuscript and Wen-Hua Hsieh, PhD, for assistance with statistical analysis. Both are employed by Harvard Clinical Research Institute and were compensated for their contributions.
Correction: This article was corrected online April 28, 2015, for errors in describing the prespecified analyses and July 5, 2016, to add an institution to an author’s affiliation.