title: Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.
abstract: OBJECTIVE
  The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions.
  
  
  BACKGROUND
  There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up.
  
  
  METHODS
  The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class.
  
  
  RESULTS
  The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was -2 (-3 to -1) in the SES group and -1 (-2 to 0) in the BMS group, respectively (p = 0.006).
  
  
  CONCLUSIONS
  Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).
authors.affiliation: Angiologie, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany. aljoscha.rastan@herzzentrum.de
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Klaus
authors.initials: K
authors.lastname: Brechtel
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Rainer
authors.initials: R
authors.lastname: Zahorsky
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Uwe
authors.initials: U
authors.lastname: Schwarzwälder
authors.forename: Roland
authors.initials: R
authors.lastname: Macharzina
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwarz
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Bürgelin
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy; D007511:Ischemia / Q000628:therapy; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*
chemical_list: D000903:Antibiotics, Antineoplastic; D020123:Sirolimus