title: Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents.
abstract: OBJECTIVE
  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).
authors.affiliation: St. Vincent Heart Center, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.affiliation: The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: 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.
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: 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.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Yeh
authors.affiliation: Department of Cardiology, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Department of Medicine, Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; School of Public Health, Boston University School of Medicine, Boston, Massachusetts.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Wen-Hua
authors.initials: WH
authors.lastname: Hsieh
authors.affiliation: Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011474:Prosthesis Design; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D011725:Pyridines; C446540:thienopyridine; D000068338:Everolimus; D001241:Aspirin
keywords: drug-eluting stent(s); dual antiplatelet therapy; everolimus; stent thrombosis