title: Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial.
abstract: OBJECTIVE
  Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery.
  
  
  RESULTS
  161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004).
  
  
  CONCLUSIONS
  Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.
authors.affiliation: Abteilung Angiologie, Herz-Zentrum Bad Krozingen, Südring 15, Bad Krozingen, Germany. aljoscha.rastan@herzzentrum.de
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Rainer
authors.initials: R
authors.lastname: Zahorsky
authors.forename: Ullrich
authors.initials: U
authors.lastname: Beschorner
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwarz
authors.forename: Klaus
authors.initials: K
authors.lastname: Brechtel
authors.forename: Catherine
authors.initials: C
authors.lastname: Böhme
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; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006085:Graft Survival; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy; D007511:Ischemia / Q000188:drug therapy; D007866:Leg / Q000098:blood supply; D008297:Male; D011150:Popliteal Artery; D011446:Prospective Studies; D015424:Reperfusion / Q000379:methods; D055502:Secondary Prevention; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*; D014654:Vascular Patency
chemical_list: D050257:Tubulin Modulators; D020123:Sirolimus