title: Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial.
abstract: OBJECTIVE
  The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus.
  
  
  BACKGROUND
  The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus.
  
  
  METHODS
  Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent.
  
  
  RESULTS
  A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization.
  
  
  CONCLUSIONS
  Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).
authors.affiliation: Department of Internal Medicine/Cardiology, University of Leipzig, Heart Center, Leipzig, Germany. stdesch@web.de
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Denis
authors.initials: D
authors.lastname: Schloma
authors.forename: Sven
authors.initials: S
authors.lastname: Möbius-Winkler
authors.forename: Sandra
authors.initials: S
authors.lastname: Erbs
authors.forename: Stephan
authors.initials: S
authors.lastname: Gielen
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Jiangtao
authors.initials: J
authors.lastname: Yu
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.forename: Klaus
authors.initials: K
authors.lastname: Kleinertz
authors.forename: Wilfried
authors.initials: W
authors.lastname: Dänschel
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus