Clinical Impacts of Sodium-Glucose Co-Transporter 2 Inhibitors in Diabetic Patients with Chronic Limb Threatening Ischaemia Undergoing Endovascular Therapy: Results of the SIRIUS Study.

Takei, Tatsuro; Tokuda, Takahiro; Yoshioka, Naoki; Ogata, Kenji; Tanaka, Akiko; Kojima, Shunsuke; Yamaguchi, Kohei; Yanagiuchi, Takashi et al. · Eur J Vasc Endovasc Surg · 2026

retrospective_cohort · Level III

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Abstract

Although sodium-glucose co-transporter 2 (SGLT2) inhibitors are effective treatments, their use may be associated with increased risk of lower limb amputation. Moreover, no studies have reported on their clinical safety and efficacy in patients with chronic limb threatening ischaemia (CLTI). Therefore, this multicentre retrospective observational study evaluated their clinical efficacy in diabetic patients with CLTI who underwent endovascular therapy (EVT). Eligible patients with diabetes and CLTI were identified retrospectively between January 2021 and December 2023 from a multicentre Japanese EVT registry. The patients were divided into two groups based on whether or not they received treatment with SGLT2 inhibitors. The clinical safety and efficacy of SGLT2 inhibitors was evaluated after propensity score matching (PSM). The primary outcome was freedom from major amputation within one year. Secondary endpoints were amputation free survival, all cause death, wound healing, cardiovascular death, and infection related death within one year. Among 257 patients, 51 matched pairs were analysed after PSM, with no baseline differences between groups. One year freedom from major amputation was similar (94.0% vs. 86.8%; p = .30), whereas amputation free survival was statistically significantly better in the SGLT2 inhibitor group (88.3% vs. 71.3%; p = .030). The all cause mortality rate was also lower with SGLT2 inhibitors (4.7% vs. 18.7%; p = .030). Wound healing (82.8% vs. 69.7%; p = .49), cardiovascular mortality (0.0% vs. 7.0%; p = .070), and infection related mortality (2.2% vs. 6.1%; p = .31) did not differ statistically significantly between the groups. SGLT2 inhibitors may not be associated with an increased risk of major lower limb amputation in patients with CLTI undergoing EVT. These agents may be associated with improved clinical outcomes in this population.