Impact of Below-the-Knee Runoff in Patients With Lower Extremity Artery Disease Who Underwent Endovascular Therapy Using Drug-Coated Balloons in Femoropopliteal Lesions

Background: The impact of below-the-knee (BK) runoff after drug-coated balloon (DCB) treatment in femoropopliteal (FP) lesions has not been well investigated.

Methods: This retrospective multicenter observational study enrolled 291 consecutive patients with lower extremity artery disease who underwent endovascular therapy with DCBs for FP lesions between January 2018 and December 2021. Patients were classified into four groups based on the BK runoff. Outcome measures included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR) and amputation, and overall survival rates at 24 months. The predictors of restenosis at 24 months were also investigated.

Results: In total, 43, 98, 117, and 33 patients were classified into three, two, one, and no BK runoff groups, respectively. In three, two, one, and no BK runoff groups, the primary patency rates were 72.1%, 67.3%, 61.4%, and 44.1% (p = 0.028); freedom from CD-TLR rates were 87.1%, 78.8%, 71.7%, and 47.1% (p < 0.001); freedom from amputation rates were 95.2%, 97.9%, 92.8%, and 91.5% (p = 0.499); and overall survival rates were 89.4%, 83.2%, 76.6%, and 61.2% (p = 0.007), respectively, at 24 months. Multivariate analysis showed that chronic limb-threatening ischemia, no BK runoff, Lutonix use, and residual stenosis > 30% were independent predictors of primary patency loss at 24 months. The risk score, calculated as the number of predictors, reflected the risk of restenosis.

Conclusion: No BK runoff was associated with worse midterm primary patency, freedom from CD-TLR, and overall survival rates than at least one BK runoff.