title: Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial.
abstract: OBJECTIVE
  Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (Cypher) as compared with that of bare stents with thin struts (BeStent 2).
  
  
  RESULTS
  A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter > or = 50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19-0.56), P<0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22-0.66), P<0.001]. For smaller vessels (< 2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent (P<0.001). For larger vessels (> or = 2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent (P=0.52).
  
  
  CONCLUSIONS
  The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.
authors.affiliation: Deutsches Herzzentrum, Lazarettstrasse 36, 80636 Munich, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Alban
authors.initials: A
authors.lastname: Dibra
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Josef
authors.initials: J
authors.lastname: Dirschinger
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000368:Aged; D023903:Coronary Restenosis / Q000517:prevention & control*; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
chemical_list: D004343:Drug Implants; D007166:Immunosuppressive Agents; D020123:Sirolimus