title: Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.
abstract: OBJECTIVE
  Despite antirestenotic efficacy of coronary drug-eluting stents (DES) compared with bare metal stents (BMS), the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Although dual antiplatelet therapy (DAPT) beyond 1 year provides ischemic event protection after DES, ischemic event risk is perceived to be less after BMS, and the appropriate duration of DAPT after BMS is unknown.
  
  
  OBJECTIVE
  To compare (1) rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE; composite of death, myocardial infarction, or stroke) after 30 vs 12 months of thienopyridine in patients treated with BMS taking aspirin and (2) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses.
  
  
  METHODS
  International, multicenter, randomized, double-blinded, placebo-controlled trial comparing extended (30-months) thienopyridine vs placebo in patients taking aspirin who completed 12 months of DAPT without bleeding or ischemic events after receiving stents. The study was initiated in August 2009 with the last follow-up visit in May 2014.
  
  
  METHODS
  Continued thienopyridine or placebo at months 12 through 30 after stent placement, in 11,648 randomized patients treated with aspirin, of whom 1687 received BMS and 9961 DES.
  
  
  METHODS
  Stent thrombosis, MACCE, and moderate or severe bleeding.
  
  
  RESULTS
  Among 1687 patients treated with BMS who were randomized to continued thienopyridine vs placebo, rates of stent thrombosis were 0.5% vs 1.11% (n = 4 vs 9; hazard ratio [HR], 0.49; 95% CI, 0.15-1.64; P = .24), rates of MACCE were 4.04% vs 4.69% (n = 33 vs 38; HR, 0.92; 95% CI, 0.57-1.47; P = .72), and rates of moderate/severe bleeding were 2.03% vs 0.90% (n = 16 vs 7; P = .07), respectively. Among all 11,648 randomized patients (both BMS and DES), stent thrombosis rates were 0.41% vs 1.32% (n = 23 vs 74; HR, 0.31; 95% CI, 0.19-0.50; P < .001), rates of MACCE were 4.29% vs 5.74% (n = 244 vs 323; HR, 0.73; 95% CI, 0.62-0.87; P < .001), and rates of moderate/severe bleeding were 2.45% vs 1.47% (n = 135 vs 80; P < .001).
  
  
  CONCLUSIONS
  Among patients undergoing coronary stent placement with BMS and who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis, MACCE, or moderate or severe bleeding. However, the BMS subset may have been underpowered to identify such differences, and further trials are suggested.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00977938.
authors.affiliation: The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio2Lindner Research Center, Cincinnati, Ohio.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts4Massachusetts General Hospital, Boston.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Yeh
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts5Boston University, Boston, Massachusetts.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Priscilla
authors.initials: P
authors.lastname: Driscoll-Shempp
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts6Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Université Paris-Diderot, Paris, France8Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France9National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: University Hospitals of Leicester, Leicester, United Kingdom.
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Gershlick
authors.affiliation: Vivantes Neukoelln Medical Center, Berlin, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Darius
authors.affiliation: Monash Heart, Victoria, Australia.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.affiliation: Mercy Hospital, Auckland, New Zealand.
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.affiliation: Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Jean Francois
authors.initials: JF
authors.lastname: Tanguay
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Lenox Hill Hospital, New York, New York.
authors.forename: Kirk N
authors.initials: KN
authors.lastname: Garratt
authors.affiliation: Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Stanford University, Stanford, California.
authors.forename: David P
authors.initials: DP
authors.lastname: Lee
authors.affiliation: University Hospitals Case Medical Center, Cleveland, Ohio.
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Simon
authors.affiliation: Heart Institute, Cluj-Napoca, Romania.
authors.forename: Adrian Corneliu
authors.initials: AC
authors.lastname: Iancu
authors.affiliation: Jan Pawel II Hospital Krakow, Krakow, Poland.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Trebacz
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts22Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000453:epidemiology; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012306:Risk; D015607:Stents
chemical_list: D010975:Platelet Aggregation Inhibitors; D011725:Pyridines; C446540:thienopyridine; D001241:Aspirin