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CHICAGO -- Surgical revascularization led to fewer major adverse limb events and deaths compared with endovascular therapy in patients with chronic limb-threatening ischemia, according to the prospective randomized BEST-CLI trial.

After a median follow-up of 2.7 years, the primary composite outcome of major adverse limb events and death from any cause occurred in 42.6% of patients who had an adequate great saphenous vein available for surgery (cohort 1) compared with 57.4% who were assigned to endovascular therapy (HR 0.68, 95% CI 0.59-0.79, P<0.001), reported Alik Farber, MD, of Boston Medical Center at Boston University.

However, no significant difference was seen among patients who needed an alternative bypass conduit (cohort 2). Here, primary outcome events occurred in 42.8% of the surgical group versus 47.7% of the endovascular group (HR 0.79, 95% CI 0.58-1.06, P=0.12) after a median follow-up of 1.6 years.

These results were presented at the American Heart Association annual meeting and published simultaneously in the .

Looking at each outcome separately, there were no differences in death from any cause between the groups in cohort 1 -- 33% of the surgery patients versus 37.6% of the endovascular patients (P=0.81) -- but the groups did differ for above-ankle amputations of the index limb (10.4% vs 14.9%, respectively, P=0.04). There were also significantly fewer major reinterventions of the index limb with surgery (9.2% vs 23.5%, P<0.001).

For cohort 2, there were no differences between the surgery and endovascular therapy groups for all-cause deaths (26.3% vs 24.1%, respectively, P=0.50) and above-ankle amputations of the index limb (14.9% vs 14.1%, P=0.72), but there was a significant difference in major reinterventions of the index limb (14.4% vs 25.6%, P=0.002).

According to current guidelines, patients with peripheral artery disease and chronic limb-threatening ischemia could be treated with either surgery or endovascular therapy. Without adequate treatment, chronic limb-threatening ischemia leads to major amputations at 1 year in 25% of patients.

"Procedure preference may vary by institution and by healthcare professional based on expertise and training, or availability of technology," Farber noted. "As minimally invasive techniques became more available 2 decades ago, there was a trend toward less bypass surgery. However, it is not clear what is best for people with chronic limb-threatening ischemia, in whom the stakes are high."

Commenting on the study, designated discussant W. Schuyler Jones, MD, of the Duke Clinical Research Institute in Durham, North Carolina, said that the evidence on which procedure is best has been thin.

"We have all been waiting in great anticipation for the results of BEST-CLI," he added. "As shown by Dr. Farber, there was an early and prolonged advantage with surgery compared with endovascular therapy. This was a large, diverse, contemporary group of patients. The study design and conduct were incredibly well done."

This international trial included 1,830 patients from 150 sites, mostly in the U.S. Cohort 1 included 718 patients in the surgery arm and 716 in the endovascular therapy arm. Across both groups, mean age was 67, 28-29% were women, 70-74% were white, and 17-22% were Black. Cohort 2 included 197 patients in the surgery arm and 199 in the endovascular therapy arm. Mean age was 68-69, 28% were women, 67-74% were white, and 21-29% were Black.

At a press conference, co-author Matthew Menard, MD, of Brigham and Women's Hospital and Harvard Medical School in Boston, noted that there was no difference in quality of life between the groups.

"The assessment tools we used did not directly measure recovery times after the procedures," he told MedPage Today, suggesting that there are indirect ways to determine what role recovery would play.

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