Efficacy of cilostazol after endovascular therapy for femoropopliteal artery disease in patients with intermittent claudication.

OBJECTIVES The purpose of this study was to investigate whether cilostazol reduces restenosis and revascularization after endovascular therapy (EVT) for femoropopliteal lesions. BACKGROUND Cilostazol improves walking distance in patients with intermittent claudication and reduces restenosis after coronary intervention, but its efficacy remains unclear after EVT for femoropopliteal disease. METHODS This study was performed as a multicenter, randomized, open-label clinical trial. Eighty patients (mean age 70.7 +/- 6.2 years, 84% men) with intermittent claudication due to a femoropopliteal lesion were randomly assigned to receive or not receive cilostazol in addition to aspirin. The primary end point was freedom from target vessel revascularization, and the secondary end points were the rate of restenosis and freedom from target lesion revascularization and major adverse cardiovascular events, defined as all-cause death, myocardial infarction, stroke, repeat revascularization, and leg amputation. RESULTS Clinical follow-up information was obtained in all patients. Patient, lesion, and procedural characteristics did not differ significantly between the 2 groups. Stenting was performed in 36 patients (cilostazol, 16; control, 20; p = 0.36). Freedom from target vessel revascularization at 2 years after EVT was significantly higher compared with the control group (84.6% vs. 62.2%, p = 0.04). The rate of restenosis was lower in the cilostazol group (43.6% vs. 70.3%, p = 0.02), and freedom from target lesion revascularization and major adverse cardiovascular events was higher in the cilostazol group (87.2% vs. 67.6%, p = 0.046, 76.8% vs. 45.6%, p = 0.006, respectively). There was no major bleeding in either group during follow-up period. CONCLUSIONS Cilostazol reduced restenosis and repeat revascularization after EVT in patients with intermittent claudication due to femoropopliteal disease.