Long-Term Clinical Impact of Successful Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

Background: Although successful vessel preparation (VP) before drug-coated balloon (DCB) treatment has been found to improve primary patency, its long-term clinical impact remains uncertain.

Aims: The present study sought to assess the long-term clinical efficacy of of of successful VP before DCB treatment for de novo femoropopliteal (FP) lesions in patients with symptomatic lower extremity artery disease.

Methods: This retrospective study analyzed 268 patients (308 limbs) who underwent successful FP endovascular therapy (EVT) for symptomatic lower extremity artery disease between March 2018 and December 2019. Successful VP was defined as < 50% residual stenosis and a dissection grade below grade D before DCB treatment. The primary endpoint was limb salvage (LS) rate, whereas the secondary endpoints included overall survival rate, primary patency, and freedom from clinically driven target lesion revascularization (CD-TLR).

Results: The median follow-up period was 4.4 (interquartile range, 1.6-5.4) years. At 5 years, the LS rate was significantly higher in the successful VP group than in the nonsuccessful VP group (94.4% vs. 87.9%, p = 0.03), but no significant difference in the overall survival rate was observed between both groups (65.6% vs. 68.7%, p = 0.82). At 5 years, the primary patency and freedom from CD-TLR were significantly higher in the successful VP group than in the nonsuccessful VP group (51.2% vs. 31.5%, p < 0.001; 65.0% vs. 51.6%, p = 0.01). Hemodialysis, chronic limb-threatening ischemia, heart failure, and successful VP before DCB treatment were identified as independent predictors of LS.

Conclusions: Successful VP before DCB treatment was independently associated with LS by improving long-term patency in FP-EVT.