Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: A double-blind, multi-centre, randomized clinical trial

Abstract

Aims Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery. Methods and results161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of <50) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in RutherfordBecker classification after 1 year. Twenty-five (15.5) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6) than in the bare-metal stent group (55.6, P 0.004), and the 1-year secondary patency rates were 91.9 and 71.4 (P 0.005), respectively. The median (interquartile range) change in RutherfordBecker classification after 1 year was-2 (-3 to-1) in the sirolimus-eluting stent group and-1 (-2 to 0) in the bare-metal stent group, respectively (P 0.004). ConclusionMid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in RutherfordBecker classification reveal a significant advantage for the sirolimus-eluting stent.Clinical Trial Registration Information: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00664963. © 2011 The Author.