BEST-CLI: Surgery Best for Avoiding Amputation in PAD Patients

A pair of studies presented at the American Heart Association 2022 Scientific Sessions are providing evidence in support of a surgical approach, rather than endovascular therapy, for reducing risk of amputation and preserving quality of life among certain patients with critical limb ischemia.

Named the Best Endovascular versus Best Surgical Therapy for Patients with Chronic Limb Threatening Ischemia (BEST-CLI) Trial, data from AHA 22 outlined the benefits of surgical rather than endovascular revascularization for patients with peripheral artery disease and great saphenous veins suitable for bypass surgery, indicating use was associated with significant reductions in rate of amputation relative to endovascular revascularization, with either approach associated with improved quality of life among patients who were successfully revascularized.

“The results we found within Group 1 are interesting in that there were significantly fewer amputations and major reoperations performed in the people who had bypass surgery, and there was no difference between the treatment groups in the number of patient deaths,” said lead investigator Alik Farber, MD, MBA, an associate chief medical officer for surgical services and chief of the division of vascular and endovascular surgery at Boston Medical Center, in a statement from the AHA. “This information debunks the idea that CLTI patients who need revascularization should have an endovascular procedure first due to concern that bypass surgery may be potentially more dangerous. In this group of people, who were at acceptable risk for surgery and had a good vein available, we determined that surgical bypass led to better outcomes.”

An international, prospective, randomized, open-label, multicenter, superiority trial, BEST-CLI was launched with the intent of comparing surgical and endovascular revascularization with the intent of comparing the approaches ability to improve limb perfusion and, subsequently, reduce risk of amputation. With this in mind, investigators designed their research endeavor to enroll patients with critical limb-threatening ischemia infrainguinal peripheral artery disease into a pair of parable-cohort trials. Specifically, the study was designed with 1 cohort characterized by the ability to use their great saphenous vein for surgery and a second cohort of patients who needed an alternative bypass conduit.

A total of 1830 patients from 150 sites in North America, Europe, and Oceania were enrolled in the study. Of these, 1434 qualified for inclusion in cohort 1 and the remaining 396 were placed into the second cohort. The 1434 enrolled in cohort 1 were than randomized to undergo bypass surgery or an endovascular procedure to restore blood flow, with 718 randomized to surgical treatment and 716 randomized to endovascular therapy. The 396 enrolled into cohort 2 were randomized to a bypass surgery using an arm vein or an artificial blood or to an endovascular procedure, with 197 randomized to surgery and 199 randomized to endovascular therapy.

The trial included 2 primary outcomes of interest. The first was a composite of a major adverse limb event, which investigators defined as s amputation above the ankle or a major limb reintervention. The second primary outcome of interest was death from any cause. The trial also included planned analyses to estimate the impact of treatment approach on quality of life among patients included in the trial, which was assessed using VascuQOL for detecting changes in PAD severity, the European Quality of Life 5D to assess general quality of life, including mobility, self-care and usual activities, the Short Form 12 to assess daily living, and a numerical scale (1 – 10) to rate pain severity.

In cohort 1, which included a median follow-up of 2.7 years, a primary outcome event was occurred among 42.6% in the surgical group and 57.4% in the endovascular group (HR, 0.68 [95% CI, 0.59-0.79]; P <.001). In cohort 2, which included a median follow-up of 1.6 years, a primary outcome event occurred among 42.8% in the surgical group and 47.7% in the endovascular group (HR, 0.79 [95% CI, 0.58-1.06]; P=.12). investigators pointed out the incidence of adverse events was similar in the 2 groups in both cohorts. Analysis of quality of life endpoints demonstrated scores were low at the beginning of the study, but pain scores decreased substantially and quality-of-life scores increased for all participants across all measures used for assessment throughout the duration of the study.

“We anticipated low levels of quality of life at the beginning of the study due to the pain and other life-altering symptoms associated with chronic limb-threatening ischemia,” said Matthew Menard, MD, an associate professor of surgery at Harvard Medical School, and co-director of endovascular surgery at the Brigham and Women’s Hospital, in a statement from the AHA around the quality of life presentation from BEST-CLI. “Improvement in health-related quality-of-life measures regardless of the type of procedure is very encouraging and highlights the importance of timely restoration of blood flow to the leg and foot.“

This study, “Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia,” was presented at AHA 22 and simultaneously published in the New England Journal of Medicine.