title: Cobalt-chromium KAname™ coRonary stEnt system in the treatment of patients with coronary artery disease (KARE study).
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions.
  
  
  BACKGROUND
  Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance.
  
  
  METHODS
  Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume.
  
  
  RESULTS
  Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months.
  
  
  CONCLUSIONS
  Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation.
authors.affiliation: CHU Rangueil Toulouse, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Carrie
authors.forename: Volker
authors.initials: V
authors.lastname: Schächinger
authors.forename: Gian Battista
authors.initials: GB
authors.lastname: Danzi
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Biljana
authors.initials: B
authors.lastname: Putnikovic
authors.forename: Andres
authors.initials: A
authors.lastname: Iniguez
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.forename: Zlatko
authors.initials: Z
authors.lastname: Mehmedbegovic
authors.forename: Branko
authors.initials: B
authors.lastname: Beleslin
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002857:Chromium; D003035:Cobalt; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000473:pathology; D011446:Prospective Studies; D015607:Stents
chemical_list: D002857:Chromium; D003035:Cobalt