2026 Volume 8 Issue 2 Pages 333-342
Background: This study evaluated the impact of Rheocarna® (Kaneka Medix, Osaka, Japan) after endovascular treatment (EVT) in patients with chronic limb-threatening ischemia (CLTI).
Methods and Results: We retrospectively analyzed consecutive data from 913 patients who underwent EVT for infrainguinal lesions between March 2021 and December 2023 at 8 centers in Japan. Patients were categorized into 2 groups based on whether they received Rheocarna: EVT alone and EVT combined with Rheocarna. Propensity score matching (PSM) was used to adjust for differences in patient and lesion characteristics. The primary outcome was the 1-year wound healing rate. Secondary outcomes included wound healing time, major amputation rate, and reintervention at 1 year. After PSM, 88 matched pairs were identified, with no significant differences in baseline characteristics between the 2 groups. Among patients with severe disease small artery disease (SAD2), the combination of EVT and Rheocarna significantly improved the wound healing rate vs. EVT alone (66.6% vs. 26.0%, respectively; P=0.01) No significant differences were observed between the 2 groups for the other endpoints.
Conclusions: Among patients with CLTI and SAD2, EVT combined with Rheocarna significantly improved the wound healing rate at 1 year, although there were no significant differences in terms of wound healing time, major amputation rate, and reintervention at 1 year. These findings suggest that patients with CLTI and SAD2 may be suitable candidates for Rheocarna treatment following EVT.
