title: Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial.
abstract: OBJECTIVE
  The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.
  
  
  BACKGROUND
  In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.
  
  
  METHODS
  We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).
  
  
  RESULTS
  At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).
  
  
  CONCLUSIONS
  At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address: okkels@dadlnet.dk.
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Aalborg, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Aalborg, Denmark.
authors.forename: Hans Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus
keywords: drug-eluting stent; percutaneous coronary intervention; very late definite stent thrombosis