title: 2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial.
abstract: OBJECTIVE
  There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).
  
  
  BACKGROUND
  In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.
  
  
  METHODS
  The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.
  
  
  RESULTS
  At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).
  
  
  CONCLUSIONS
  At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Hans Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.forename: Henrik Steen
authors.initials: HS
authors.lastname: Hansen
authors.forename: Hans Erik
authors.initials: HE
authors.lastname: Bøtker
authors.forename: Lars Romer
authors.initials: LR
authors.lastname: Krusell
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D003643:Death; D003718:Denmark; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D016037:Single-Blind Method; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus