Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease

Background: Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis. Methods: We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed. Results: There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26–26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30–16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis. Conclusions: Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia.