title: Randomized trial of stents versus bypass surgery for left main coronary artery disease.
abstract: BACKGROUND
  Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice.
  
  
  METHODS
  We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups.
  
  
  RESULTS
  The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).
  
  
  CONCLUSIONS
  In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).
authors.affiliation: Heart Institute, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. sjpark@amc.seoul.kr
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.forename: Duk-Woo
authors.initials: DW
authors.lastname: Park
authors.forename: Sung-Cheol
authors.initials: SC
authors.lastname: Yun
authors.forename: Jung-Min
authors.initials: JM
authors.lastname: Ahn
authors.forename: Hae Geun
authors.initials: HG
authors.lastname: Song
authors.forename: Jong-Young
authors.initials: JY
authors.lastname: Lee
authors.forename: Won-Jang
authors.initials: WJ
authors.lastname: Kim
authors.forename: Soo-Jin
authors.initials: SJ
authors.lastname: Kang
authors.forename: Seung-Whan
authors.initials: SW
authors.lastname: Lee
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.forename: Seong-Wook
authors.initials: SW
authors.lastname: Park
authors.forename: Cheol-Hyun
authors.initials: CH
authors.lastname: Chung
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Do-Sun
authors.initials: DS
authors.lastname: Lim
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.forename: Sang-Gon
authors.initials: SG
authors.lastname: Lee
authors.forename: Hyeon-Cheol
authors.initials: HC
authors.lastname: Gwon
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.forename: Myung-Ho
authors.initials: MH
authors.lastname: Jeong
authors.forename: Seung-Jea
authors.initials: SJ
authors.lastname: Tahk
authors.forename: Ki Bae
authors.initials: KB
authors.lastname: Seung
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002318:Cardiovascular Diseases / Q000453:epidemiology; D001026:Coronary Artery Bypass; D023921:Coronary Stenosis / Q000601:surgery* / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000601:surgery / Q000628:therapy; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage
chemical_list: D020123:Sirolimus