In patients with chronic limb-threatening ischemia, surgical revascularization is better than endovascular therapy (BEST-CLI)

Reference

Farber A, Menard MT, Conte MS, et al, for the BEST-CLI Investigators. Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med 2022;387(25):2305-2316.

Synopsis

These researchers identified patients with chronic limb-threatening ischemia, defined as foot pain at rest, nonhealing ischemic ulcer, or gangrene. Patients who were felt to be poor risks for surgery were excluded. The patients' mean age was 67 years. Patients were evaluated and randomly assigned to 1 of 2 groups: cohort 1 had 1434 patients with a single greater saphenous vein segment that was suitable for bypass, and cohort 2 had 396 patients without such a segment who would require an alternate conduit for surgery. Patients in both cohorts were then randomized to receive surgical bypass or an endovascular procedure chosen by the patient's physician. Within each cohort, groups were balanced and analysis was by intention to treat. In both cohorts, well over 90% of those assigned to surgery actually underwent surgery, and almost all of those assigned to an endovascular therapy received that intervention. The primary outcome was a composite of all-cause mortality or a major adverse limb event, defined as an above-ankle amputation or need for a major vascular intervention in the limb. In cohort 1, this outcome was significantly less likely in the surgery group (42.6% vs 57.4%; hazard ratio 0.68; 95% CI 0.59 - 0.79; number needed to treat = 7). Deaths were numerically less common, but this difference was not statistically significant (33.0% vs 37.6%). Both amputations (10.4% vs 14.9%) and major vascular interventions (9.2% vs 23.5%) were significantly less common in the surgery group. Differences between groups were smaller and nonsignificant in cohort 2 (the group without a suitable single saphenous vein segment for bypass). Serious adverse events and cardiovascular events were similar between groups in both cohorts.