Cardiovascular and interventional radiology · 2026
Clinical Outcomes in Chronic Limb-Threatening Ischemia Patients Undergoing Femoropopliteal Endovascular Treatment Using IN.PACT versus Ranger: Results of the PEPPERMINT Study.
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Nagatomi Satoru, Takahara Mitsuyoshi, Kobayashi Taira, Fujimura Naoki, Yamaoka Terutoshi, Matsuda Daisuke, Okazaki Takanobu, Mochizuki Shingo, Shingaki Masami, Endo Masayuki, Hosokawa Kyosuke, Furuyama Tadashi, Shintani Tsunehiro, Sekimoto Yasuhito, Uchiyama Hidetoshi, Kyuragi Ryoichi, Watada Susumu, Morisaki Koichi, Mitsuoka Hiroki, Kawai Yohei, Banno Hiroshi, Hayashi Keita, Shibata Tsuyoshi, Kamei Shunsuke, Obara Hideaki, Ichihashi Shigeo, PEPPERMINT Investigators
Аннотация
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.
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.