Current Status And Clinical Outcomes Of Endovascular Treatment In Patients With Femoropopliteal Lesions From The Registry Of Endovascular Treatment For Femoropopliteal Artery Disease (REAL- LEAD)

Background) The device-specific outcomes of endovascular therapy (EVT) for lower extremity arterial disease (LEAD) with femoropopliteal artery (FPA) lesions in Japan have been reported in multicenter clinical studies. Based on this evidence, we aimed to evaluate the current status of EVT for FPA lesions by assessing the 1-year patency rate, the final device use rate, and the association of a loss of patency in a real-world setting. Methods) We prospectively enrolled 316 limbs of 281 patients who underwent EVT for FPA lesions between September 2021 and December 2022. The primary outcome was defined as the primary patency of a target FPA lesion at 1 year. The secondary outcomes, freedom from clinically driven (CD) target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse limb events (MALE), were analyzed by Kaplan-Meier curves. The associations of loss of patency were analyzed by a logistic regression model. Results) Approximately 70% of patients received drug-coated balloon (DCB) monotherapy, 10% received drug-eluting stent, and 12% received combination therapy as DCB plus scaffolding device. We demonstrated that the primary patency rate was 81.4%. Freedom from CD-TLR, CD-TVR, and MALE were seen in 94.6 ± 1.36%, 91.4 ± 1.69%, and 87.5 ± 1.95% of the cases, respectively. Loss of primary patency was associated with sex(female), chronic limb-threatening ischemia, history of revascularization, pre-balloon angioplasty without a scoring balloon, severe calcification, and lesions involving the popliteal artery. Conclusion) DCB angioplasty was performed frequently, and the outcomes of EVT in FPA lesions were acceptable in a real-world setting. Clinical trial number : This study is not applicable.