title: Randomized comparison of percutaneous coronary intervention with sirolimus-eluting stents versus coronary artery bypass grafting in unprotected left main stem stenosis.
abstract: OBJECTIVE
  The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery disease.
  
  
  BACKGROUND
  CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial.
  
  
  METHODS
  In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.
  
  
  RESULTS
  The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33).
  
  
  CONCLUSIONS
  In patients with ULM stenosis, PCI with sirolimus-eluting stents did not show noninferiority [corrected] to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard endpoints, [corrected] PCI results are favorable. A longer follow-up is warranted. [corrected]
authors.affiliation: Department of Internal Medicine/Cardiology, University of Leipzig-Heart Center, Germany.
authors.forename: Enno
authors.initials: E
authors.lastname: Boudriot
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.forename: Christoph
authors.initials: C
authors.lastname: Liebetrau
authors.forename: Peter
authors.initials: P
authors.lastname: Boeckstegers
authors.forename: Tilmann
authors.initials: T
authors.lastname: Pohl
authors.forename: Bruno
authors.initials: B
authors.lastname: Reichart
authors.forename: Harald
authors.initials: H
authors.lastname: Mudra
authors.forename: Florian
authors.initials: F
authors.lastname: Beier
authors.forename: Brigitte
authors.initials: B
authors.lastname: Gansera
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Michael
authors.initials: M
authors.lastname: Gick
authors.forename: Thomas
authors.initials: T
authors.lastname: Zietak
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Friedrich-Wilhelm
authors.initials: FW
authors.lastname: Mohr
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus