One-Year ACHILLES Results Published for Cordis Select-Plus DES in Infrapopliteal Disease

November 26, 2012—In the Journal of the American College of Cardiology, Dierk Scheinert, MD, et al published 1-year results from the ACHILLES trial that investigated the efficacy and safety of a balloon-expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease (2012;60:2290–2295). The investigators concluded that SES implantation may offer a promising therapeutic alternative to percutaneous transluminal balloon angioplasty (PTA) for treatment of infrapopliteal peripheral arterial disease.

The investigators stated that the background of the investigation is that the results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could potentially be improved by stabilizing the lesion with an SES. The ACHILLES study was designed to evaluate the Cypher Select-Plus stent (Cordis Corporation, Bridgewater, NJ).

As detailed in the Journal of the American College of Cardiology, 200 patients (total lesion length, 27 ± 21 mm) were randomized to infrapopliteal SES stenting or PTA. The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. 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 = .019), greater vessel patency (75% vs 57.1%; P = .025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA, reported the investigators.