title: Effect of paclitaxel elution from reservoirs with bioabsorbable polymer compared to a bare metal stent for the elective percutaneous treatment of de novo coronary stenosis: the EUROSTAR-II randomised clinical trial.
abstract: OBJECTIVE
  To compare the angiographic and clinical performance of a paclitaxel-eluting stent using reservoirs technology and a bioabsorbable polymer, without surface coating (CoStar), vs. an equivalent bare metal stent (BMS) using an identical metallic platform.
  
  
  RESULTS
  Three hundred and three (303) patients (335 lesions) with de novo coronary artery stenosis suitable for elective percutaneous treatment were randomised in an international multicentre single-blind trial to receive the CoStar stent (n=152) or the equivalent BMS (n=151). At eight months, the primary endpoint of in-segment binary restenosis was significantly lower in the CoStar than in the BMS group (17.6 vs. 30.3%, p=0.029). In-stent late loss (0.41 vs. 0.81 mm; p<0.0001) and all the other angiographic secondary endpoints also favoured CoStar. The composite of cardiac death, myocardial infarction related to the target vessel and target lesion revascularisation was significantly lower at eight months in the CoStar arm (19.7 vs. 29.1%; hazard ratio 0.54, 95% CI: 0.34-0.87; p=0.010), mainly due to lower incidence of target lesion revascularisation (15.1 vs. 26.5%; 95% CI: hazard ratio 0.45, 95% CI: 0.27-0.76; p=0.002).
  
  
  CONCLUSIONS
  As compared with a bare metal stent of identical design, the paclitaxel elution from reservoirs results in significantly less binary restenosis, less late loss and lower revascularisation rates at eight months. Therefore, based on these data, the CoStar paclitaxel-eluting stent was found to be effective and safe.
authors.affiliation: Heart Centre at Isar, Munich, Germany. sigmund@silber.com
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Gutiérrez-Chico
authors.forename: Steffen
authors.initials: S
authors.lastname: Behrens
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Stefan
authors.initials: S
authors.lastname: Hoffmann
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.forename: Darius
authors.initials: D
authors.lastname: Harald
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.forename: Christoph
authors.initials: C
authors.lastname: Nienaber
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D016037:Single-Blind Method; D015607:Stents
chemical_list: D008670:Metals; D011108:Polymers; D017239:Paclitaxel