title: Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial.
abstract: BACKGROUND
  We studied the Nobori coronary stent coated with a bioabsorbable polymer and the anti-proliferative agent Biolimus A9 which may reduce neointimal formation.
  
  
  RESULTS
  Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori (85 patients) or paclitaxel eluting stent Taxus(R) (35 patients). The two groups were well matched in baseline characteristics. The primary end point of non-inferiority for in-stent late loss of Nobori stent versus Taxus(R) stent, at 9 months, was reached with the values of 0.15+/-0.27 mm with Nobori stent and 0.32+/-0.33 mm with Taxus(R) stent (p=0.006). Neointimal volume obstruction was 2.2+/-6.0% and 8.9+/-9.2% for Nobori and Taxus(R) stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori stent, and 0%, 8.6% and 14.3% respectively for Taxus(R) stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori stent and 2.9% for Taxus(R) stent. Stent thrombosis rates at 9 months were 0% in both groups.
  
  
  CONCLUSIONS
  In this trial the Nobori Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.
authors.affiliation: Centre Cardiologique du Nord, Saint-Denis, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Eulogio
authors.initials: E
authors.lastname: Garcia
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.forename: Karl
authors.initials: K
authors.lastname: Hauptmann
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Farzin
authors.initials: F
authors.lastname: Fath-Ordoubadi
authors.forename: Stephen
authors.initials: S
authors.lastname: Worthley
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Marco
authors.initials: M
authors.lastname: Bressers
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nagai
authors.forename: Dragica
authors.initials: D
authors.lastname: Paunovic