BEST-CLI: Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

On Thursday afternoon, vascular surgeon Eric Scott, MD, from The Iowa Clinic in Des Moines, presented a review of the results from the BEST-CLI study, which were published in The New England Journal of Medicine. Over 150 medical centers participated in this study, with a targeted enrollment of 2,100 participants across the United States, Canada, Italy, Finland, and New Zealand. Dr Scott began by outlining the trial design and presenting an overview of the study. 

BEST-CLI was an international, prospective, randomized trial of patients with critical limb-threatening ischemia (CLTI) and infrainguinal peripheral arterial disease. Patients were enrolled if 2 operators (1 with expertise in bypass and 1 with expertise in endovascular therapy) both agreed that the patient could be equally treated by either surgery or endovascular therapy. There was a 1:1 randomization between surgical bypass and any available endovascular therapy. Participants were followed up every 6 months up to 7 years, and the primary endpoints were major adverse limb events (MALEs) and death. MALEs included major amputation, new bypass, bypass revision, thrombectomy, and thrombolysis. The 1830 participants were divided into 2 cohorts: 1436 were in the adequate great saphenous vein (GSV) cohort and 396 were in the alternative cohort (patients who lacked an adequate saphenous vein). 

Dr Scott presented the primary outcomes of the study. In cohort 1, incidence of a MALE or death was significantly lower in the surgical group than endovascular group. In cohort 2, the outcomes in the 2 groups were similar. He then questioned how generalizable the BEST-CLI results are, as the enrollment rate for the study was only 2.8% of the potential patients screened. 

In closing, Dr Scott summarized the BEST-CLI findings. The study found significantly higher rates of major secondary intervention following endovascular therapy vs bypass surgery in patients with suitable GSV, and it found no differences in death, MI, or major amputation in either cohort. These data are only applicable to the CLTI patient believed equally treated by either strategy.

BEST-CLI is not, he said, a depiction of how most CLTI is treated; it’s not a randomized, controlled trial; and it does not provide evidence to abandon an endovascular-first approach.