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, on behalf of the ACHILLES Investigators (Park-Krankenhaus Leipzig-Südost GmbH, Germany; et al) J Am Coll Cardiol 60:2290-2295, 2012^§

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 (Figs 2 and 3).

Figure 2 Angiographic results at 12-month follow-up. Primary endpoints for the intention-to-treat (ITT) population (A), the as-treated population (B), and the diabetic subpopulation (C). Abbreviations as in Figure 1. (Reprinted from Scheinert D, on behalf of the ACHILLES Investigators. 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. J Am Coll Cardiol. 2012;60:2290-2295, Copyright 2012, with permission from the American College of Cardiology.)

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