Percutaneous transluminal angioplasty for treatment of ''below-the-knee'' critical limb ischemia: early outcomes following the use of sirolimus-eluting stents.

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.