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.