title: Five-year clinical outcome of the Nobori drug-eluting coronary stent system in the treatment of patients with coronary artery disease: final results of the NOBORI 1 trial.
abstract: OBJECTIVE
  To assess the safety and performance of the Nobori drug-eluting stent with biodegradable polymer versus the TAXUS drug-eluting stent with permanent polymer, in the treatment of patients with de novo coronary artery lesions.
  
  
  RESULTS
  NOBORI 1 was a multicentre, randomised (2:1), prospective, controlled, clinical trial which enrolled 363 patients (238 Nobori and 125 TAXUS) with up to two de novo lesions in two epicardial vessels. The primary endpoint was in-stent late loss at nine months, while secondary endpoints included safety and efficacy up to five years. At five years, clinical data were available for 350 patients (96%). There were no differences in the composite of death and myocardial infarction (10.9% vs. 11.2%) and target lesion failure (9.2% and 10.4%), while ischaemia- and non-ischaemia-driven target lesion revascularisations were less frequent in the Nobori (6.3%) than in the TAXUS arm (16.0%). The rates of stent thrombosis (definite and probable according to the ARC definitions) were 0.0% and 3.2%, in the Nobori and TAXUS stents, respectively (p=0.014).
  
  
  CONCLUSIONS
  Five years after implantation, the Nobori DES resulted in durable treatment effects with very low TLR and no stent thrombosis. The study was not powered to assess the differences in clinical endpoints. These data are hypothesis-generating.
authors.affiliation: Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Eulogio
authors.initials: E
authors.lastname: Garcia
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
authors.forename: Dragica
authors.initials: D
authors.lastname: Paunovic
authors.forename: Patrick
authors.initials: P
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003324:Coronary Artery Disease / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology*; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: C518022:umirolimus; D020123:Sirolimus