ResearchPod Summary
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease that carries a high risk of amputation. While both surgical bypass and endovascular therapy are standard treatments, there has been significant uncertainty regarding which approach is superior for improving limb outcomes. The BEST-CLI trial aimed to compare these two strategies in patients who were considered suitable candidates for both.
This international, randomized, multicenter trial enrolled 1830 patients and divided them into two parallel cohorts based on the availability of an autogenous conduit (the great saphenous vein). Cohort 1 included patients with an adequate great saphenous vein, while Cohort 2 included those who required an alternative conduit. Patients were randomized 1:1 to either surgical or endovascular revascularization. The primary outcome was a composite of major adverse limb events (amputation or major reintervention) or death from any cause.
In Cohort 1, patients who underwent surgery had a significantly lower incidence of the primary outcome compared to those who received endovascular therapy (42.6% vs. 57.4%; hazard ratio 0.68). This benefit was primarily driven by a lower rate of major reinterventions and above-ankle amputations in the surgical group. In Cohort 2, where patients lacked an adequate saphenous vein, there was no statistically significant difference in the primary outcome between the two treatment groups (42.8% vs. 47.7%). The incidence of major adverse cardiovascular events and perioperative death was similar across both cohorts and treatment groups.
The results of this trial provide clear evidence that for patients with an available great saphenous vein, surgical bypass should be the preferred initial strategy for treating CLTI. Conversely, when a high-quality vein is not available, the choice between surgery and endovascular therapy is less clear-cut, suggesting that clinical decision-making should be highly individualized. These findings help standardize care for a complex, high-risk patient population.
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