title: Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial.
abstract: OBJECTIVE
  The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.
  
  
  BACKGROUND
  The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.
  
  
  METHODS
  The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.
  
  
  RESULTS
  Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%.
  
  
  CONCLUSIONS
  The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).
authors.affiliation: Stanford University School of Medicine, Palo Alto, California, USA.
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Ash
authors.initials: A
authors.lastname: Jain
authors.forename: Thaddeus R
authors.initials: TR
authors.lastname: Tolleson
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Spriggs
authors.forename: Brent T
authors.initials: BT
authors.lastname: Mc Laurin
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000453:epidemiology* / Q000473:pathology; D023903:Coronary Restenosis / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control; D003331:Coronary Vessels / Q000187:drug effects* / Q000473:pathology; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000453:epidemiology / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: C489443:zotarolimus; D020123:Sirolimus