Abstract 6187: Clinical Impact of Cilostazol after Endovascular Therapy in Femoropopliteal Artery
Background: Endovascular therapy (EVT) has become standard therapy for patients with symptomatic peripheral artery disease (PAD). Although initial success rate of EVT is high, higher restenosis rate is a limitation. Cilostazol retrospectively has been reported to reduce target lesion revascularization in the femoropopliteal artery.
Aim: The aim of this study was to investigate whether cilostazol would reduce restenosis and target vessel revascularization after EVT of femoropopliteal disease.
Methods: This study was a multicenter, randomized, open-label clinical trial. From October 2004 to October 2005, 80 patients were randomized to receive either cilostazol + aspirin (Clz) or aspirin alone (Ctrl) for femoropopliteal disease. Of these, 2 patients were not meeting inclusion criteria. 78 patients enrolled (Clz: n=39; Ctrl: n=39). Clinical endpoint was clinically driven target vessel revascularization (TVR) and major adverse event (MAE). MAE was defined as death, non-fetal myocardial infarction, stroke, revascularization, bypass surgery and amputation. They were followed-up using duplex ultrasound and/or angiography.
Results: All patient was obtained clinical information. Patient, lesion and procedural characteristics of patients were not significantly different between both groups. The freedom from clinically driven TVR rate at 2 years was significantly higher and restenosis rate was lower in the Clz group than in the Ctrl group (84.6% vs 64.1%, p = 0.049, 43.6% vs 66.7%, p=0.04, respectively). Also, freedom from MAE rate were higher in Clz group than in Ctrll group (77% vs. 46%, p=0.003). Upon multivariate Cox analysis, treatment with cilostazol (hazard ratio (HR) 0.28, 95%confidential interval (CI) 0.08 – 0.99, p = 0.05), diabetes (HR 4.9, 95%CI 1.4 –17.2, p = 0.013), reference diameter (HR 0.47, 95%CI 0.25– 0.91, p = 0.025), and chronic total occlusion (HR 4.2, 95%CI 1.2 –14.8, p = 0.027) were independent predictors of clinically driven TVR after EVT.
Conclusion: Cilostazol taken orally after EVT in femoropopliteal artery significantly reduced the rate of restenosis and clinically driven TVR at 2 years.