title: A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial.
abstract: OBJECTIVE
  The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease.
  
  
  BACKGROUND
  Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES.
  
  
  METHODS
  Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography.
  
  
  RESULTS
  Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA.
  
  
  CONCLUSIONS
  SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.
authors.affiliation: Department for Angiology, Park-Krankenhaus Leipzig-Südost GmbH, Leipzig, Germany. dierk.scheinert@gmx.de
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Renate
authors.initials: R
authors.lastname: Koppensteiner
authors.forename: Philip
authors.initials: P
authors.lastname: Commeau
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Mariella
authors.initials: M
authors.lastname: Van Ransbeeck
authors.forename: Ayesha C
authors.initials: AC
authors.lastname: Qureshi
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation / Q000379:methods*; D054855:Drug-Eluting Stents; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D008297:Male; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011859:Radiography; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus