title: Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial.
abstract: BACKGROUND
  Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.
  
  
  OBJECTIVE
  To compare the first 2 commercially available drug-eluting stents-sirolimus-eluting and paclitaxel-eluting-for prevention of symptom-driven clinical end points, using a study design reflecting everyday clinical practice.
  
  
  METHODS
  Randomized, blinded trial conducted August 2004 to January 2006 at 5 university hospitals in Denmark. Patients were 2098 men and women (mean [SD] age, 63.6 [10.8] years) treated with percutaneous coronary intervention (PCI) and randomized to receive either sirolimus-eluting (n = 1065) or paclitaxel-eluting (n = 1033) stents. Indications for PCI included ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina pectoris, and stable angina.
  
  
  METHODS
  The primary end point was a composite clinical end point of major adverse cardiac events, defined as either cardiac death, acute myocardial infarction, target lesion revascularization, or target vessel revascularization. Secondary end points included individual components of the composite end point, all-cause mortality, and stent thrombosis.
  
  
  RESULTS
  The sirolimus- and the paclitaxel-eluting stent groups did not differ significantly in major adverse cardiac events (98 [9.3%] vs 114 [11.2%]; hazard ratio, 0.83 [95% confidence interval, 0.63-1.08]; P = .16) or in any of the secondary end points. The stent thrombosis rates were 27 (2.5%) and 30 (2.9%) (hazard ratio, 0.87 [95% confidence interval, 0.52-1.46]; P = .60), respectively.
  
  
  CONCLUSIONS
  In this practical randomized trial, there were no significant differences in clinical outcomes between patients receiving sirolimus- and paclitaxel-eluting stents.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00388934.
authors.affiliation: Department of Cardiology, Gentofte University Hospital, Hellerup, Copenhagen, Denmark. anders@galloe.dk
authors.forename: Anders M
authors.initials: AM
authors.lastname: Galløe
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Klaus
authors.initials: K
authors.lastname: Rasmussen
authors.forename: Peter R
authors.initials: PR
authors.lastname: Hansen
authors.forename: Niels
authors.initials: N
authors.lastname: Bligaard
authors.forename: Kari
authors.initials: K
authors.lastname: Saunamäki
authors.forename: Anders
authors.initials: A
authors.lastname: Junker
authors.forename: Jens
authors.initials: J
authors.lastname: Aarøe
authors.forename: Ulrik
authors.initials: U
authors.lastname: Abildgaard
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.forename: Thomas
authors.initials: T
authors.lastname: Engstrøm
authors.forename: Jan S
authors.initials: JS
authors.lastname: Jensen
authors.forename: Henning R
authors.initials: HR
authors.lastname: Andersen
authors.forename: Hans E
authors.initials: HE
authors.lastname: Bøtker
authors.forename: Søren
authors.initials: S
authors.lastname: Galatius
authors.forename: Steen D
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Jan K
authors.initials: JK
authors.lastname: Madsen
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.forename: Steen Z
authors.initials: SZ
authors.lastname: Abildstrøm
authors.forename: Ghita B
authors.initials: GB
authors.lastname: Stephansen
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus