Rotational Atherectomy-Assisted Balloon Angioplasty versus Plain Balloon Angioplasty for Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: A Retrospective Observational Study
Abstract
Objective: This study aimed to compare procedural and mid-term clinical outcomes between rotational atherectomy-assisted balloon angioplasty (RA+POBA) and POBA alone for infrapopliteal (IP) lesions in patients with chronic limb-threatening ischemia (CLTI). Methods: This retrospective study included 71 consecutive patients with CLTI who underwent endovascular intervention for IP peripheral arterial disease between January 2020 and January 2025 and had at least 6 months of follow-up. A total of 78 limbs were analyzed and categorized into RA+POBA and POBA groups. The primary outcome was target lesion revascularization (TLR) during follow-up. Limb-level outcomes were analyzed accounting for within-patient clustering. Results: Patient-level analysis included 35 patients in the RA+POBA group and 36 patients in the POBA group. Follow-up duration was similar between groups (18.0 [12–63] vs. 21.0 [12–82] months; p=0.919). TLR occurred in 6 limbs in both groups (15.4% vs. 15.4%; risk ratio [RR] 1.15, 95% confidence interval [CI] 0.23–5.66; p=0.866). Major amputation occurred in 1 limb in the RA+POBA group and 9 limbs in the POBA group (2.6% vs. 23.1%; RR 0.12, 95% CI 0.02–0.81; p=0.030). No significant differences were observed in minor amputation or all-cause mortality. Conclusion: In this retrospective cohort, RA+POBA was associated with a lower major amputation rate. However, this secondary, unadjusted finding was based on a limited number of events and should be considered hypothesis-generating. Furthermore, the absence of differences in TLR and mortality suggests that these findings should not be interpreted as evidence of superior patency, durability, or survival benefit.