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

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 RESULTS: 161 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 Rutherford-Becker 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 Rutherford-Becker 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). CONCLUSION: Mid-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 Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.

Primary use of sirolimus-eluting stents in the infrapopliteal arteries.

PURPOSE: To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia. METHODS: A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification. RESULTS: Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year. CONCLUSION: Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.