Efficacy of statin treatment after endovascular therapy for isolated below-the-knee disease in patients with critical limb ischemia.

To investigate the efficacy of statin treatment after endovascular therapy (EVT) for isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). From March 2004 to June 2011, 812 patients (984 limbs, 69.0 % male, 71.6 ± 10.0 years old) with CLI underwent successful EVT for de novo isolated BTK lesions at 11 cardiovascular centers in Japan. Of these patients, 169 patients were treated with statins. Successful EVT was defined as direct-line flow to the pedal arch with <30 % residual stenosis. The multicenter data were analyzed retrospectively for outcomes of overall survival, amputation-free survival (AFS), cardiovascular death, limb salvage, freedom from repeat revascularization, and major adverse limb events [MALE: repeat revascularization for the limb or major amputation (defined as above-the-ankle amputation)]. The mean follow-up period was 19.4 ± 17.6 months. Overall survival, AFS and freedom from repeat revascularization at 4 years were significantly higher in patients treated with statins (64.5 vs. 45.9 %, P = 0.004; 64.1 vs. 43.0 %, P = 0.003; and 56.4 vs. 45.4 %, P = 0.03, respectively). However, rates of cardiovascular death, limb salvage, and MALE at 4 years did not differ significantly between the two groups (86.0 vs. 75.2 %, P = 0.11; 87.2 vs. 87.7 %, P = 0.39; and 84.4 vs. 82.9 %, P = 0.64, respectively). After adjusting all outcomes against differences in prespecified baseline variables, there was no significant difference in overall survival, AFS, cardiovascular death, limb salvage, repeat revascularization, and MALE between the groups. In a subgroup of 513 patients who were ambulatory at baseline, statin treatment significantly improved overall survival [hazard ratio (HR) 0.54, 95 % confidential interval (CI) 0.29-0.97, adjusted P = 0.04] and numerically improved AFS (HR 0.63, 95 % CI 0.35-1.07, adjusted P = 0.086). In this subgroup analysis, there was no significant difference in the rates of repeat revascularization, cardiovascular death, limb salvage, and MALE between patients treated with and without statins. In this retrospective study, the statin treatment after successful EVT establishing one straight line for isolated BTK lesions with CLI do not influence overall survival, AFS, and the rates of cardiovascular death, limb salvage, and MALE. However, in ambulatory patients, the statins may improve overall survival and AFS after successful EVT establishing one straight line for isolated BTK lesions.