The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries.

Abstract

A comparison was made of sirolimus-eluting stents and bare stents as an effective means of treatment of stenosis in crural arteries. Patients were randomly divided into two groups: (1) patients treated with sirolimus-eluting stents and (2) patients treated with bare stents. Each group consisted of 25 patients, and every patient had one stent implanted. All patients showed symptoms of ischemia of the peripheral arteries, classified according to the Rutherford scale into categories 3, 4, and 5. All patients were examined 24 h before and 24 h and 6 months after the intervention. The results were analyzed according to clinical, hemodynamic, and angiographic criteria. Technically, the procedure was successful in 100% of cases, and both groups presented an equal improvement in clinical and hemodynamic parameters. The follow-up angiographic examination demonstrated a significantly lower rate of restenosis among the sirolimus-eluting stent group (4, 16%) versus the bare stent group (19, 76%) (p < 0.001), with lower target lesion revascularization in 3 (12%) versus 14 (56%) (p < 0.05), respectively. Quantitative angiography demonstrated that all variables used to assess restenosis were superior for sirolimus-eluting stents 6 months after intervention: late lumen loss 0.46 +/- 0.72 versus 1.70 +/- 0.94 (p < 0.001) and minimal lumen diameter 2.25 +/- 0.82 versus 0.99 +/- 1.08 (p < 0.001). Results of this study reveal that the use of sirolimus-eluting stents decreases the risk of restenosis in comparison to standard stents.