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
Dierk Scheinert, Konstantinos Katsanos, Thomas Zeller, Renate Koppensteiner, Philip Commeau, Marc Bosiers, Hans Krankenberg, Iris Baumgartner, Dimitris Siablis, Johannes Lammer, Mariella Van Ransbeeck, Ayesha C Qureshi, Hans-Peter Stoll, ACHILLES Investigators, Dierk Scheinert, Dimitris Siablis, Konstantinos Katsanos, Dimitris Karnabatidis, Thomas Zeller, Johannes Lammer, Renate Koppensteiner, Marc Bosiers, Phillippe Commeau, Hans Krankenberg, Iris Baumgartner, Paolo Rubino, Klaus Brechtel, Volker Geist, Peter Huppert, Wouter Lansink, Jan Peregrin, Paul Sidhu, Pierre-Edouard Magnan, Dierk Scheinert, Konstantinos Katsanos, Thomas Zeller, Renate Koppensteiner, Philip Commeau, Marc Bosiers, Hans Krankenberg, Iris Baumgartner, Dimitris Siablis, Johannes Lammer, Mariella Van Ransbeeck, Ayesha C Qureshi, Hans-Peter Stoll, ACHILLES Investigators, Dierk Scheinert, Dimitris Siablis, Konstantinos Katsanos, Dimitris Karnabatidis, Thomas Zeller, Johannes Lammer, Renate Koppensteiner, Marc Bosiers, Phillippe Commeau, Hans Krankenberg, Iris Baumgartner, Paolo Rubino, Klaus Brechtel, Volker Geist, Peter Huppert, Wouter Lansink, Jan Peregrin, Paul Sidhu, Pierre-Edouard Magnan
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.
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed