From Monash Heart and Monash University, Melbourne, Australia (I.T.M., W.-H.H.); Montreal Heart Institute, Université de Montréal, Québec, Canada (J.-F.T.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Beth Israel Deaconess Medical Center, Boston, MA (D.E.C.); Harvard Clinical Research Institute, Boston, MA (D.E.C., R.W.Y., J.M.M., L.M.); Harvard Medical School, Boston, MA (D.E.C., R.W.Y., L.M.); The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.); Lenox Hill Hospital, New York, NY (K.N.G.); Stanford University, Stanford, CA (D.P.L.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique–Hôpitaux de Paris – all in Paris, National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Henry Ford Medical Group, Detroit, MI (W.D.W.); Mayo Clinic, Rochester, MN (D.R.H.); Institute for Health Policy Studies, University of California, San Francisco (R.G.B.); Jan Pawel II Hospital Krakow, Poland (J.T.); Boston University School of Public Health, Boston, MA (J.M.M.); and Brigham and Women’s Hospital, Boston, MA (L.M.).
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Background—Patients with diabetes mellitus (DM) are at high risk for recurrent ischemic events after coronary stenting. We assessed the effects of continued thienopyridine among patients with DM participating in the Dual Antiplatelet Therapy (DAPT) Study as a prespecified analysis.Methods and Results—After coronary stent placement and 12 months treatment with open-label thienopyridine plus aspirin, 11 648 patients free of ischemic or bleeding events and who were medication compliant were randomly assigned to continued thienopyridine or placebo, in addition to aspirin, for 18 more months. After randomization, patients with DM (n=3391), in comparison with patients without DM (n=8257), had increased composite outcome of death, myocardial infarction (MI), or stroke (6.8% versus 4.3%, P<0.001), increased death (2.5% versus 1.4%, P<0.001), and MI (4.2% versus 2.6%, P<0.001). Among patients with DM, in a comparison of continued thienopyridine versus placebo, rates of stent thrombosis were 0.5% versus 1.1%, P=0.06, and rates of MI were 3.5% versus 4.8%, P=0.058; and among patients without DM the rates were 0.4% versus 1.4%, P<0.001 (stent thrombosis, P interaction=0.21) and 1.6% versus 3.6%, P<0.001 (MI, P interaction=0.02). Bleeding risk with continued thienopyridine was similar among patients with or without DM (interaction P=0.61).Conclusions—In patients with DM, continued thienopyridine beyond 1 year after coronary stenting is associated with reduced risk of MI, although this benefit is attenuated in comparison with patients without DM.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.