Association Between Balloon Size and Clinical Outcomes After Inframalleolar Angioplasty for Chronic Limb-Threatening Ischemia.

BACKGROUND: Vessel diameter measured by intravascular ultrasound (IVUS) in inframalleolar (IM) lesions is larger than the balloon size commonly used in practice. It remains unclear which patients receive balloons comparable to IVUS-reported sizes and whether this affects outcomes.

METHODS: We conducted a retrospective, multicenter study of 230 patients with chronic limb-threatening ischemia (CLTI) who underwent IM balloon angioplasty between January 2018 and August 2022. Patients were divided into two groups: those who underwent angioplasty with balloon size ≥2.5 mm, comparable to vessel diameters reported in previous IVUS studies (n = 44), and those treated with smaller balloon size <2.5 mm (n = 186). One-year outcomes, including amputation-free survival (AFS), wound healing, and freedom from target lesion revascularization (TLR), were compared. Propensity score matching (PSM) analysis was conducted.

RESULTS: PSM identified 35 pairs. At 1 year, there were no significant differences in AFS (76.1% vs. 70.6%; P = 0.72) or wound healing rates (71.5% vs. 60.0%; P = 0.76) between the two groups. However, the large balloon group had a significantly higher freedom from TLR rate (79.4% vs. 45.7%; P = 0.004). Multivariate analysis identified balloon diameter ≥2.5 mm as a predictor of freedom from TLR (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.06-0.56; P = 0.003) and severe medial arterial calcification as a risk factor for TLR (HR, 5.9; 95% CI, 1.13-30.9; P = 0.04).

CONCLUSION: The use of balloons with a diameter ≥2.5 mm, comparable to vessel sizes reported in previous IVUS studies, was associated with a higher 1-year freedom from TLR in CLTI patients undergoing IM angioplasty.