title: Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction.
abstract: BACKGROUND
  The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations.
  
  
  OBJECTIVE
  This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI.
  
  
  METHODS
  The Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding.
  
  
  RESULTS
  Of 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 30.7% presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group, 0.5% vs. 1.9%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21).
  
  
  CONCLUSIONS
  Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study]; NCT00977938).
authors: Massachusetts General Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
authors: Robert W
authors: RW
authors: Yeh
authors: The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio.
authors: Dean J
authors: DJ
authors: Kereiakes
authors: Université Paris-Diderot, Paris, France, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom.
authors: Philippe Gabriel
authors: PG
authors: Steg
authors: Bern University Hospital, Bern, Switzerland.
authors: Stephan
authors: S
authors: Windecker
authors: The Sanger Heart and Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina.
authors: Michael J
authors: MJ
authors: Rinaldi
authors: Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom.
authors: Anthony H
authors: AH
authors: Gershlick
authors: Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors: Donald E
authors: DE
authors: Cutlip
authors: Saint Luke's Mid-America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
authors: David J
authors: DJ
authors: Cohen
authors: Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors: Jean-Francois
authors: JF
authors: Tanguay
authors: Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts.
authors: Alice
authors: A
authors: Jacobs
authors: Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.
authors: Stephen D
authors: SD
authors: Wiviott
authors: Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts.
authors: Joseph M
authors: JM
authors: Massaro
authors: Heart Institute, University of Medicine Iuliu Hatieganu, Cluj Napoca, Romania.
authors: Adrian C
authors: AC
authors: Iancu
authors: Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
authors: Laura
authors: L
authors: Mauri
mesh_terms: D001241:Aspirin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control*; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000517:prevention & control*; D011725:Pyridines / Q000008:administration & dosage*; D018570:Risk Assessment; D015607:Stents; D013927:Thrombosis / Q000517:prevention & control*; D013997:Time Factors
chemical_list: D010975:Platelet Aggregation Inhibitors; D011725:Pyridines; C446540:thienopyridine; D001241:Aspirin
keywords: acute coronary syndromes; antiplatelet therapy; myocardial infarction; percutaneous coronary intervention; randomized clinical trial