Initial Management of Critical Limb-Threatening Ischemia

By Joshua A. Beckman, M.D.

Professor of Internal Medicine
Director of Vascular Medicine

At #AHA22, the vascular community focused on the first report of the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial. This NHLBI-sponsored trial persevered through the pandemic to enroll 1,830 patients with chronic limb-threatening ischemia (CLTI) and tested the hypothesis that bypass surgery would have superior amputation-free survival in patients whose anatomy permitted revascularization with either modality. The study had two cohorts, one in which participants could receive saphenous vein bypass grafts and the other in which participants received an alternative bypass conduit. The investigators reported that in the intention-to-treat population, those who received a vein bypass graft, rather than an endovascular intervention, had a significant reduction in the rate of major reinterventions (9.2 % vs. 23.3%) and amputation above the ankle (10.3% vs. 14.8%) but no difference in mortality (35% for the overall cohort) after 2.7 years of follow-up. In cohort 2, which compared alternative bypass conduit with endovascular approaches, no significant difference was noted in primary outcome of major adverse limb events or death from any cause, although the size of this cohort was much smaller (396 patients compared with more than 1,400 in cohort 1).

This initial report likely represents the beginning of the story rather than its end. Presented in the same session was the quality-of-life data from the BEST-CLI trial. The endovascular versus surgical participants had higher quality-of-life scores despite more amputations but not to a degree that was felt to be a clinically meaningful difference between these two groups. Why those assigned to bypass surgery did not have a better quality-of-life score versus those assigned to an endovascular intervention, given the fewer additional procedures and amputations in the former group, is not clear. Importantly, quality of life did increase dramatically in both arms of the trials, an observation demonstrating that revascularization, by whichever modality, results in patients feeling much better. Thus, efforts to salvage limbs are beneficial – by reducing risk of amputation and improving quality of life – even in a patient population with a > 10% per year mortality.

Email: joshua.beckman@utsouthwestern.edu

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