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Published on: January 18, 2018
Endovascular Treatment Alone vs. Endovascular Treatment Plus Rheocarna for Patients With Chronic Limb-Threatening
Takahiro Tokuda1, Naoki Yoshioka2, Akiko Tanaka3
1Department of Cardiology, Nagoya Heart Center Nagoya Japan.
Insights
Rheocarna® significantly improved wound healing in patients with chronic limb-threatening ischemia (CLTI) and small artery disease (SAD2) after endovascular treatment (EVT). This suggests Rheocarna may benefit specific CLTI patients undergoing EVT.
Area of Science:
- Vascular Surgery
- Regenerative Medicine
- Clinical Research
Background:
- Chronic limb-threatening ischemia (CLTI) poses a significant clinical challenge.
- Endovascular treatment (EVT) is a common intervention for infrainguinal lesions.
- Evaluating adjunct therapies to improve outcomes after EVT is crucial.
Purpose of the Study:
- To assess the impact of Rheocarna® as an adjunct therapy following EVT in CLTI patients.
- To compare wound healing rates and other clinical outcomes between EVT alone and EVT with Rheocarna®.
- To identify patient subgroups who may benefit most from Rheocarna®.
Main Methods:
- Retrospective analysis of 913 CLTI patients undergoing EVT for infrainguinal lesions.
- Patients grouped into EVT alone or EVT with Rheocarna®.
- Propensity score matching (PSM) used to control for baseline differences; 88 matched pairs analyzed.
- Primary outcome: 1-year wound healing rate; secondary outcomes: healing time, amputation, reintervention.
Main Results:
- In patients with small artery disease (SAD2), the EVT plus Rheocarna® group showed a significantly higher 1-year wound healing rate (66.6%) compared to EVT alone (26.0%; P=0.01).
- No significant differences were observed between groups for wound healing time, major amputation rate, or reintervention rate at 1 year.
- PSM successfully balanced baseline characteristics between the 88 matched pairs.
Conclusions:
- Adjunctive Rheocarna® therapy significantly improved 1-year wound healing rates in CLTI patients with SAD2 undergoing EVT.
- Rheocarna® did not significantly impact wound healing time, major amputation, or reintervention rates in this cohort.
- Patients with CLTI and SAD2 may be suitable candidates for Rheocarna® treatment post-EVT.
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.
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