Abstract 10421: Factors Associated With Early and Late Restenosis Following Drug-Coated Balloon Treatment for Patients in Femoropopliteal Lesions

Abstract

Introduction: Drug-coated balloon (DCB) improves clinical outcomes and has created a paradigm shift in the treatment of femoropopliteal (FP) lesions. However, in real-world FP practice, we occasionally experience early restenosis after DCB treatment despite the achievement of angiographic success at initial endovascular treatment (EVT). The objectives of this study was to elucidate factors associated with early (within 6-month) and late restenosis (after 6-month) following DCB treatment for real-world FP lesions. Methods: This was a multicenter and retrospective study enrolling 486 lesions (lesion length: 12±10 cm, chronic total occlusion [CTO]: 21%, involving popliteal arterial lesions: 43%) in 423 patients (age: 74±9 years, female: 29%, diabetes mellitus: 61%, hemodialysis: 38%, chronic limb-threatening ischemia: 42%) who underwent EVT using DCB between January 2018 and December 2019 in three cardiovascular centers. The outcome measure was primary patency, and the predictors of early and late restenosis were explored by cox proportional regression analysis. Results: During the mean observation period of 25.3±12.1 months, primary patency at 6-, 12-, 24-, and 36-month was 93.1%, 79.1%, 61.6%, and 48.7%, respectively. A total of 31 lesions and 138 lesions developed early and late restenosis, respectively. Multivariate analysis revealed that CTO lesion (Hazard ratio [HR]: 2.29, p=0.033) and involving ostial lesion of superficial femoral artery (HR: 2.73, p=0.009) were significantly associated with early restenosis, while calcification angle over 270° (HR: 1.66, p=0.005), smaller distal external elastic membrane (EEM) diameter evaluated by intravascular ultrasound (HR: 1.03, p< 0.001) and involving popliteal arterial lesions (HR: 1.53, p=0.018) were significantly associated with late restenosis. Conclusions: The factors associated with early restenosis following DCB treatment for real-world FP lesions differed from those with late restenosis.