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Original Article Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents Laura Mauri, M.D., Dean J. Kereiakes, M.D., Robert W. Yeh, M.D., Priscilla Driscoll-Shempp, M.B.A., Donald E. Cutlip, M.D., P. Gabriel Steg, M.D., Sharon-Lise T. Normand, Ph.D., Eugene Braunwald, M.D., Stephen D. Wiviott, M.D., David J.

Cohen, M.D., David R. Holmes, Jr., M.D., Mitchell W. Krucoff, M.D., James Hermiller, M.D., Harold L. Dauerman, M.D., Daniel I. Simon, M.D., David E. Kandzari, M.D., Kirk N.

Garratt, M.D., David P. Lee, M.D., Thomas K. Pow, M.D., Peter Ver Lee, M.D., Michael J.

Rinaldi, M. Download Free Software Home Design 3d. D., and Joseph M. Massaro, Ph.D., for the DAPT Study Investigators N Engl J Med 2014; 371:2155-2166 DOI: 10.1056/NEJMoa1409312 open through December 10, 2014. Methods Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed.

After 12 months of treatment with a thienopyridine drug (clopidogrel or prasugrel) and aspirin, patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another 18 months; all patients continued receiving aspirin. The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) during the period from 12 to 30 months. The primary safety end point was moderate or severe bleeding. Figure 1 Enrollment, Randomization, and Follow-up.

Patients were enrolled within 72 hours after stent placement. They were followed for 12 months while they received open-label treatment with thienopyridine plus aspirin and were then randomly assigned to receive thienopyridine therapy or placebo (each in addition to aspirin) for an additional 18 months.

The randomized treatment period ended at 30 months; thereafter, patients continued taking aspirin only and were followed for another 3 months. Although the number of patients with available data on clinical follow-up is reported in each group, the coprimary efficacy end points were analyzed with the last available follow-up information in the intention-to-treat population, which included all patients who underwent randomization. GUSTO denotes Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries. Figure 2 Cumulative Incidence of Stent Thrombosis, According to Study Group. Cumulative incidence curves are shown for the primary efficacy end point of probable or definite stent thrombosis, as assessed according to the criteria of the Academic Research Consortium, in the intention-to-treat population. Randomization occurred at 12 months after stenting. The primary-analysis period was the period from month 12 to month 30 after percutaneous coronary intervention (i.e., the 18 months after randomization, during which subjects received the randomized study drug).