title: Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV.
abstract: BACKGROUND
  Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.
  
  
  OBJECTIVE
  This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.
  
  
  METHODS
  Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.
  
  
  RESULTS
  At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).
  
  
  CONCLUSIONS
  At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [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: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
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, Aalborg University Hospital, 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, Odense University Hospital, Odense, Denmark.
authors.forename: Henrik Steen
authors.initials: HS
authors.lastname: Hansen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Krusell
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, Denmark.
authors.forename: Hans Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.affiliation: Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
authors.forename: Klara
authors.initials: K
authors.lastname: Berencsi
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Junker
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D003324:Coronary Artery Disease / Q000601:surgery*; D003718:Denmark / Q000453:epidemiology; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D012189:Retrospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000494:pharmacology*; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: drug-eluting stent(s); outcome; percutaneous coronary intervention; very late definite stent thrombosis