- Question
- In patients with chronic limb-threatening ischemia (CLTI), is an initial strategy of surgical revascularization or of endovascular therapy superior for improving limb outcomes?
- Design
- International, randomized, open-label (unmasked) trial of 1830 patients enrolled in two parallel cohorts according to the availability of adequate great saphenous vein. Median follow-up was 2.7 years in cohort 1 and 1.6 years in cohort 2.
- Population
- Patients with CLTI and infrainguinal peripheral artery disease. Cohort 1 included those with a single segment of great saphenous vein usable for surgery; cohort 2 included those who needed an alternative bypass conduit.
- Intervention
- Surgical revascularization (bypass) as the initial strategy.
- Control
- Endovascular therapy as the initial strategy.
- Primary outcome
- Composite of a major adverse limb event (above-ankle amputation or major reintervention, such as a new bypass graft, graft revision, thrombectomy, or thrombolysis) or death from any cause.
- Results
- In cohort 1, the primary outcome occurred in 302 of 709 patients (42.6%) with surgery and 408 of 711 (57.4%) with endovascular therapy (HR 0.68; 95% CI 0.59 to 0.79; P<0.001). In cohort 2, it occurred in 83 of 194 (42.8%) and 95 of 199 (47.7%), respectively (HR 0.79; 95% CI 0.58 to 1.06; P = 0.12).
- Safety
- The incidence of adverse events was similar between groups in both cohorts.
- Conclusion
- With adequate great saphenous vein, surgery significantly reduced the risk of a major adverse limb event or death compared with endovascular therapy; without adequate vein, outcomes were similar.
- Why it matters
- The trial provided large-scale randomized evidence to guide the choice between surgery and endovascular therapy in CLTI, and highlighted the availability of suitable autologous vein as a key factor in that decision.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026