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

  • D. S
  • K. K
  • T. Z
 et al. 
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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

  • *angioplasty
  • *artery
  • *drug eluting stent
  • *human
  • *infrapopliteal artery
  • *knee
  • *limb disease
  • *patient
  • *percutaneous transluminal angioplasty
  • *peripheral occlusive artery disease
  • *peripheral occlusive artery disease/dt [Drug Ther
  • *peripheral occlusive artery disease/th [Therapy]
  • *popliteal artery
  • *rapamycin XT - peripheral occlusive artery disea
  • *rapamycin/dt [Drug Therapy]
  • *stent
  • aged
  • angiography
  • artery disease
  • article
  • clinical effectiveness
  • controlled study
  • death
  • diabetes mellitus
  • female
  • human
  • implantation
  • limb amputation
  • major clinical study
  • male
  • multicenter study
  • peripheral occlusive artery disease/dt [Drug Thera
  • priority journal
  • randomized controlled trial
  • repeat procedure
  • restenosis
  • revascularization
  • safety
  • vascular patency

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  • Scheinert D.

  • Katsanos K.

  • Zeller T.

  • Koppensteiner R.

  • Commeau P.

  • Bosiers M.

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