One-year results of drug-coated balloons for long and occlusive Femoropopliteal artery disease: a single-arm trial.

BACKGROUND: The performance of drug-coated balloons (DCBs) in femoropopliteal interventions has been proven through randomized trials in short lesions and lesions with relatively low proportion of occlusions. There is limited evidence of DCBs in long or occlusive lesions. This study is to investigate the efficacy of the paclitaxel-coated balloon for treatment of long and occlusive femoropopliteal arterial lesions. METHODS: A single-arm trial including 44 femoropopliteal lesions (chronic total occlusion (CTO) plus > 10 cm) treated with DCBs was performed to collect data of average 1-year follow-up. Endpoints contain primary patency, target lesion revascularization (TLR), amelioration of the Rutherford classification, change of ankle brachial index (ABI) and major adverse events. RESULTS: Technical success is 97.7% while device success is 100%. Mean lesion length was 186 +/- 86.3 cm. Stent implantation was performed in 13.6%. Cumulative probability of primary patency was 78.8% +/- 6.8% at 1 year while that of freedom from TLR was 91.4% +/- 4.9%. Rutherford classification improved from average 3.3 +/- 1.0 to 2.1 +/- 1.4 (p < 0.001) at follow-up with a 72.7% amelioration rate. Ankle-branchial index changed from 0.33 +/- 0.40 to 0.67 +/- 0.37 (p = 0.002). No major adverse event was observed. CONCLUSION: These results suggest that it is safe and effective to treat long and totally occlusive femoropopliteal artery disease with DCBs. Further studies are demanded to confirm these results.