Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study.

PURPOSE: To report the 6-month angiographic results from a prospective single-center study investigating the efficacy and outcome of sirolimus-eluting stents used for bailout after infrapopliteal revascularization of patients with critical limb ischemia (CLI).
METHODS: Twenty-nine patients (21 men; mean age 68.7 years) underwent infrapopliteal revascularization with bare metal stents (group B) implanted for bailout in 65 lesions (38 stenoses and 27 occlusions) in 40 infrapopliteal arteries. Another 29 patients (21 men; mean age 68.8 years) underwent infrapopliteal bailout stenting with sirolimus-eluting stents (group S) in 66 lesions (46 stenoses and 20 occlusions) in 41 vessels. Preliminary 6-month angiographic and clinical results were analyzed.
RESULTS: Hyperlipidemia and symptomatic cardiac and carotid diseases were more pronounced in group S (p<0.05). Technical success was 96.6% (28/29 limbs) in group B versus 100.0% in group S (p=0.16). Six-month primary patency was 68.1% in group B versus 92.0% in group S (p<0.002). Binary in-stent and in-segment restenosis rates were 55.3% and 66.0%, respectively, in patients with bare stents versus 4.0% and 32.0%, respectively, in patients treated with the sirolimus-eluting stents (both p<0.001). The target lesion re-intervention rate at 6 months was 17.0% in group B versus 4.0% in group S (p=0.02). Limb salvage was 100% in both groups. Six-month mortality and minor amputation rates were 6.9% and 17.2%, respectively, in group B versus 10.3% and 3.4%, respectively, in group S (p=0.32 and p=0.04, respectively).
CONCLUSIONS: Sirolimus-eluting stents seem to restrict neointimal hyperplasia in the infrapopliteal vascular bed.