title: Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study.
abstract: BACKGROUND
  The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents.
  
  
  RESULTS
  We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients.
  
  
  CONCLUSIONS
  Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.
authors.affiliation: Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 DaeHak-ro, JongRo-gu, Seoul, 110-744, Korea. hyosoo@snu.ac.kr
authors.forename: Hyeon-Cheol
authors.initials: HC
authors.lastname: Gwon
authors.forename: Joo-Yong
authors.initials: JY
authors.lastname: Hahn
authors.forename: Kyung Woo
authors.initials: KW
authors.lastname: Park
authors.forename: Young Bin
authors.initials: YB
authors.lastname: Song
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Do-Sun
authors.initials: DS
authors.lastname: Lim
authors.forename: Kyoo-Rok
authors.initials: KR
authors.lastname: Han
authors.forename: Jin-Ho
authors.initials: JH
authors.lastname: Choi
authors.forename: Seung-Hyuk
authors.initials: SH
authors.lastname: Choi
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.forename: Bon-Kwon
authors.initials: BK
authors.lastname: Koo
authors.forename: Taehoon
authors.initials: T
authors.lastname: Ahn
authors.forename: Jung-Han
authors.initials: JH
authors.lastname: Yoon
authors.forename: Myung-Ho
authors.initials: MH
authors.lastname: Jeong
authors.forename: Taek-Jong
authors.initials: TJ
authors.lastname: Hong
authors.forename: Woo-Young
authors.initials: WY
authors.lastname: Chung
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Choi
authors.forename: Seung-Ho
authors.initials: SH
authors.lastname: Hur
authors.forename: Hyuck-Moon
authors.initials: HM
authors.lastname: Kwon
authors.forename: Dong-Woon
authors.initials: DW
authors.lastname: Jeon
authors.forename: Byung-Ok
authors.initials: BO
authors.lastname: Kim
authors.forename: Si-Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Nam-Ho
authors.initials: NH
authors.lastname: Lee
authors.forename: Hui-Kyung
authors.initials: HK
authors.lastname: Jeon
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000188:drug therapy* / Q000453:epidemiology; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D012307:Risk Factors; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin