Impact of 1-month dual antiplatelet therapy after treatment with drug-coated balloon for femoropopliteal artery disease.

Established data describing the optimal duration of dual antiplatelet therapy (DAPT) after endovascular therapy (EVT) for patients with peripheral artery disease (PAD) are limited. This study is a prospective, multi-center single-arm study evaluating 1-month DAPT on clinical outcomes following EVT using drug-coated balloon (DCB) for patients with symptomatic femoropopliteal artery (FPA) disease. A total of 151 patients with de novo FPA lesions which planned DCB therapy were enrolled from seven centers. DAPT (aspirin 100 mg/day and clopidogrel 75 mg/day) was started prior to EVT and continued 1-month after EVT, and subsequent aspirin monotherapy was continued during follow-up period. The primary endpoint was 1-year primary patency, as assessed by duplex ultrasound. Secondary endpoints included re-occlusion, target lesions revascularization (TLR), major amputation, acute limb ischemia (ALI), and bleeding events at one year. Mean age was 74.6 ± 8.8 and critical limb ischemia were observed in 48 patients (31.8%). Mean lesion length was 14.1 ± 9.7 cm and chronic occluded lesions were 23.8%. The primary patency rate was 74.3% at 1-year (the median period: 12.9 months). The rate of freedom from re-occlusion, TLR, and major amputation was 84.0, 86.1, and 88.2% respectively. There were no incidence of ALI and life-threatening bleedings. One-month DAPT and subsequent aspirin monotherapy following EVT with DCB for FPA lesions might be an option in terms of the bleeding risk. Further investigations with large number of subjects are required to reveal the optimal antiplatelet therapy for PAD patients.