title: Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss.
abstract: BACKGROUND
  Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis.
  
  
  RESULTS
  To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (P=0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups).
  
  
  CONCLUSIONS
  The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Rainer
authors.initials: R
authors.lastname: Wessely
authors.forename: Alban
authors.initials: A
authors.lastname: Dibra
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Birgit
authors.initials: B
authors.lastname: Jaschke
authors.forename: Josef
authors.initials: J
authors.lastname: Dirschinger
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000368:Aged; D020099:Coated Materials, Biocompatible; D004305:Dose-Response Relationship, Drug; D016503:Drug Delivery Systems; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers / Q000592:standards / Q000627:therapeutic use*; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects / Q000592:standards; D015996:Survival Rate
chemical_list: D020099:Coated Materials, Biocompatible; D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus