Clinical Outcomes in Chronic Limb-Threatening Ischemia Patients Undergoing Femoropopliteal Endovascular Treatment Using IN.PACT versus Ranger: Results of the PEPPERMINT Study.

PURPOSE: To compare the clinical outcomes of high-dose PCB (HD-PCB) and low-dose PCB (LD-PCB) in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS: This study is a multicenter retrospective observational study conducted at 21 institutions in Japan. Patients with CLTI who underwent femoropopliteal endovascular treatment using IN.PACT Admiral DCB (HD-PCB, 3.5 μg/mm2) or Ranger DCB (LD-PCB, 2.0 μg/mm2) were compared. Inverse probability of treatment weighting (IPTW) using propensity scores was applied to adjust for intergroup differences. The primary outcome was restenosis; ten secondary outcomes were also evaluated. RESULTS: A total of 323 patients were included (IN.PACT, n = 211; Ranger, n = 112). Median follow-up was 11.6 months. No significant difference in restenosis was observed between groups (HR 1.05; 95% CI 0.74-1.50; P = 0.78). After Bonferroni correction, slow flow occurred significantly more frequently in the IN.PACT group than in the Ranger group (6.8% vs. 1.0%; OR 11.9; 99.5% CI 1.27-59.3; P = 0.002). No significant intergroup differences were observed in target lesion revascularization, major adverse limb events, wound healing, major amputation, or mortality. CONCLUSIONS: Treatment outcomes for femoropopliteal lesions in patients with CLTI were comparable between the IN.PACT Admiral and Ranger DCBs. However, slow-flow phenomenon was observed more frequently in the IN.PACT group, warranting further investigation. LEVEL OF EVIDENCE: Level 3, Cohort Study.