Impact of Femoropopliteal Drug-Coated Balloon Use on Clinical Outcomes in Patients With Chronic Limb-Threatening Ischemia.

Abstract

Background: Drug-coated balloons (DCBs) for femoropopliteal (FP) lesions have demonstrated superiority over standard percutaneous transluminal angioplasty (PTA) in maintaining vessel patency. However, data on whether the good durability of DCBs translates into improved wound outcome in chronic limb-threatening ischemia (CLTI) patients are limited.

Aims: The aim of this study was to compare the effectiveness of FP-DCBs with that of standard PTA in achieving superior wound healing outcomes in CLTI patients.

Methods: This was a sub-analysis of the multicenter, retrospective, observational SAPLING (SAtellite database of Patients with chronic Limb-threateniNG Ischemia) registry. CLTI patients with tissue loss who underwent endovascular therapy for FP lesions with either DCBs or PTA were analyzed using propensity score matching. Patients were classified into the DCB group or the PTA group. The primary outcome measure was 2-year wound healing.

Results: A total of 701 limbs were included in this study. After propensity score matching, the 2-year cumulative incidence of wound healing was not significantly different between the DCB and PTA group (76.7% vs. 67.5%; hazard ratio: 1.129; 95% confidence interval: 0.861-1.480, p = 0.382). Interaction analysis demonstrated that DCB use was associated with a higher wound healing rate in patients with Wound grade 2 or 3 (p for interaction = 0.002) and foot Infection grade 2 or 3 (p for interaction = 0.03) in the Wound, Ischemia, and foot Infection classification.

Conclusions: DCB use for FP lesions was not significantly associated with superior wound healing in patients with CLTI. However, DCB may offer benefits for patients with higher wound and foot infection grades.