Impact of cilostazol after endovascular treatment for infrainguinal disease in patients with critical limb ischemia.

BACKGROUND Cilostazol reduces restenosis and repeat revascularization after endovascular therapy (EVT) in claudicant patients with femoropopliteal lesions. However, the efficacy of cilostazol in patients with critical limb ischemia (CLI) is unclear. Therefore, we investigated the effect of cilostazol on outcomes in patients with CLI. METHODS From January 2004 to December 2009, 618 patients (30.8% women, 356 treated with cilostazol, 72.4 ± 7.3 years old) with CLI underwent EVT for de novo infrainguinal lesions. Their data were retrospectively analyzed. The primary outcome measure was amputation-free survival (AFS), The secondary outcome measures were overall survival, limb salvage, freedom from repeat revascularization, and freedom from surgical conversion. Mean follow-up was 21 ± 14 months. RESULTS AFS and the limb salvage rate at 5 years were significantly higher in the cilostazol-treated group (47.7% vs 32.7%, P < .01; 86.6% vs 75.3%, P < .01; respectively). However, overall survival and freedom from repeat revascularization at 5 years did not differ significantly between the two groups (43.9% vs 46.0%, P = .24; 39.9% vs 31.8%, P = .21, respectively). Freedom from surgical conversion at 5 years was significantly higher in the cilostazol-treated group (91.0% vs 81.2%, P < .01). After correcting all end points with baseline variables, cilostazol was effective for prevention of AFS (hazard ratio [HR], 0.67; 95% confidential interval [CI], 0.49-0.91; adjusted P = .01) and improvement of limb salvage rate (HR, 0.42; 95% CI, 0.25-0.69; adjusted P < .01). There was no significant difference in overall survival, repeat revascularization, and surgical conversion between the groups. CONCLUSIONS Cilostazol may improve AFS and limb salvage rate after EVT for infrainguinal disease in patients with CLI.