title: Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial).
abstract: OBJECTIVE
  The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected.
  
  
  RESULTS
  The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent.
  
  
  CONCLUSIONS
  At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.
authors.affiliation: Department of Internal Medicine - Cardiology, University of Leipzig - Heart Center, Leipzig, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Stiermaier
authors.forename: Anja
authors.initials: A
authors.lastname: Heinz
authors.forename: Denis
authors.initials: D
authors.lastname: Schloma
authors.forename: Klaus
authors.initials: K
authors.lastname: Kleinertz
authors.forename: Wilfried
authors.initials: W
authors.lastname: Dänschel
authors.forename: Sandra
authors.initials: S
authors.lastname: Erbs
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Enno
authors.initials: E
authors.lastname: Boudriot
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus
keywords: coronary artery disease; drug-eluting stent; paclitaxel; polymer-free; sirolimus