title: Real-world safety and effectiveness outcomes of a zotarolimus-eluting stent: final 3-year report of the RESOLUTE International study.
abstract: OBJECTIVE
  We evaluated the safety and effectiveness of the Resolute™ zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years.
  
  
  BACKGROUND
  A randomized comparison of the R-ZES and the XIENCE V™ everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice.
  
  
  METHODS
  RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end-point was the composite of cardiac death and target vessel myocardial infarction (TV-MI) at 1 year. Secondary end-points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).
  
  
  RESULTS
  At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV-MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.
  
  
  CONCLUSIONS
  The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials.
authors: Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
authors: Jorge A
authors: JA
authors: Belardi
authors: Petr
authors: P
authors: Widimský
authors: Franz-Josef
authors: FJ
authors: Neumann
authors: Laura
authors: L
authors: Mauri
authors: Mariano
authors: M
authors: Albertal
mesh_terms: D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: C489443:zotarolimus; D020123:Sirolimus
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