title: Randomized comparison of the Nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries.
abstract: OBJECTIVE
  The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher).
  
  
  BACKGROUND
  The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent.
  
  
  METHODS
  We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months.
  
  
  RESULTS
  At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient.
  
  
  CONCLUSIONS
  Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.
authors.affiliation: Kurashiki Central Hospital, Kurashiki, Japan. k-kadota@lapis.plala.or.jp
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kadota
authors.forename: Toshiya
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Masashi
authors.initials: M
authors.lastname: Iwabuchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Ikari
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.forename: Kenshi
authors.initials: K
authors.lastname: Fujii
authors.forename: Naoto
authors.initials: N
authors.lastname: Inoue
authors.forename: Atsuo
authors.initials: A
authors.lastname: Namiki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000401:mortality; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007564:Japan; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011091:Polyesters; D011108:Polymers; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); C518022:umirolimus; D020123:Sirolimus