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

  • Scheinert D
  • Katsanos K
  • Zeller T
 et al. 
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Abstract

Objectives: 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. © 2012 American College of Cardiology Foundation.

Author-supplied keywords

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary
  • Drug-Eluting Stents
  • Europe
  • Female
  • Follow-Up Studies
  • Humans
  • Ischemia
  • Male
  • Peripheral Arterial Disease
  • Popliteal Artery
  • Prospective Studies
  • Sirolimus
  • Treatment Outcome
  • aged
  • angiography
  • angioplasty
  • article
  • below the knee artery
  • clinical effectiveness
  • controlled study
  • critical limb disease
  • drug eluting stent
  • drug-eluting stent
  • female
  • human
  • infrapopliteal artery
  • limb amputation
  • major clinical study
  • male
  • multicenter study
  • percutaneous transluminal angioplasty
  • peripheral arterial disease
  • peripheral occlusive artery disease
  • popliteal artery
  • priority journal
  • randomized controlled trial
  • rapamycin
  • repeat procedure
  • restenosis
  • safety
  • vascular patency

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Authors

  • D Scheinert

  • K Katsanos

  • T Zeller

  • R Koppensteiner

  • P Commeau

  • M Bosiers

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