Three Year Clinical Outcomes of Drug‐Coated Balloons in Patients With Femoropopliteal Chronic Total Occlusion: Results From the Multicenter EAGLE Study

Background Several studies have reported the effectiveness of drug‐coated balloon (DCB) for femoropopliteal (FP) chronic total occlusion (CTO). Aims The EAGLE study aimed to investigate the real‐world clinical outcomes of DCB for FP CTO lesions at 3 years. Four risk factors for 1‐year restenosis were considered: hemodialysis, chronic limb‐threatening ischemia, restenosis lesion, and no dual antiplatelet therapy use. Methods This retrospective multicenter registry analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP CTO between July 2017 and February 2021. The primary outcome was 3‐year primary patency. Secondary outcomes were 3‐year rates of freedom from: clinically driven target lesion revascularization (CD‐TLR); re‐occlusion; acute limb ischemia (ALI). Three‐year clinical outcomes, based on four 1‐year restenosis risk factors, were investigated using Cox proportional hazards regression models. Results The 3‐year rate of primary patency was 47.9% (95% confidence interval: 42.2%−54.4%), whereas the corresponding rates of freedom from CD‐TLR, re‐occlusion, and ALI were 61.9% (56.4%−68.0%), 77.5% (72.3%−83.1%), and 96.4% (94.3%−98.5%), respectively. The bailout stent rate was 8.9%. Risk factor accumulation was associated with a lower rate of 3‐year freedom from restenosis. Primary patency rates were 47.9% overall, with subgroup results of 65.2% (no risk factors), 47.1% (one risk factor), and 29.8% (two or more). Conclusions Outcomes of DCB for FP CTOs of patients without restenosis factors at 1 year were acceptable, but 3‐year patency was low in patients with multiple risk factors. Freedom from CD‐TLR, re‐occlusion, and ALI outcomes were acceptable.