Aim: We investigated the safety and efficacy of sirolimus-eluting stents in the treatment of patients with severe below-the-knee' critical limb ischemia.
Methods: Between October 2004 and January 2005 we performed 20 percutaneous transluminal angioplasty procedures on 18 patients (7 female, 11 male, mean age 72.8 years), implanting 24 sirolimus-eluting stents. At pre-procedure, 12 patients (66.7%) presented with a Rutherford Category 4, 4 (22.2%) with Category 5 and 2 (11.1%) with Category 6. The majority of patients (72.2%, n=13) were non-smokers and 77.8% (n=14) presented with hypercholesterolemia. Calcification was present in 52.2% (n=12) of lesions. Pre-dilation was performed in half the patients. The majority of lesions (95.7%, n=22) were treated with a single sirolimus-eluting stent. Two patients underwent 2 procedures, each one receiving 2 sirolimus-eluting stents. Clinical examination and quantitative vascular analysis were performed in all patients at discharge and at 6-month follow-up.
Results: Percutaneous transluminal angioplasty was successfully performed on all 18 patients. The mean stent length and stent diameter were 30.29 mm and 3.23 mm, respectively. Mean follow-up was 256 days (170-368 days). At the 6-month follow-up, the minimum lumen diameter as measured by Quantitative Vessel Analysis was 2.39 mm with an attendant LLS of 0.38 mm. The overall 6-month survival and limb salvage rate were 94.4% and 94%, respectively.
Conclusions: Our results suggest that treatment with sirolimus-eluting stents can be considered as an effective and safe treatment of patients with critical ischemia.