New Analysis Contextualizes BEST-CLI Trial Findings in Real-World Setting

May 19, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced findings from a new analysis of chronic limb-threatening ischemia (CLTI) treatment outcomes that sought to evaluate the generalizability of the BEST-CLI study to the clinical population with CLTI.

According to SCAI, after publication of the initial results of the BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients with Critical Limb Ischemia) clinical trial showing surgical intervention was superior to endovascular revascularization, questions remained regarding how inclusive the enrolled patient population was, how reflective the specialty of the physicians who performed the procedures are compared to the broader breakdown of specialists in the United States performing peripheral procedures, and whether outcome rates are similarly observed in clinical practice among Medicare beneficiaries. The BEST-CLI study was presented at the American Heart Association 2022 Scientific Sessions held November 5-7 in Chicago, Illinois, and simultaneously published by Alik Farber, MD, et al in The New England Journal of Medicine (2022; 387:2305-2316).

Eric A. Secemsky, MD, Director of Vascular Intervention, Beth Israel Deaconess Medical Center in Boston, Massachusetts, the Lead Investigator of the new analysis, “Contextualizing the BEST-CLI Trial Results in Clinical Practice,” presented the findings as late-breaking clinical research at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona.

According to SCAI, the new study sought to analyze a broader clinical population by identifying all Medicare beneficiaries between 2016 to 2019 and age 65 to 85 years with a diagnosis of CLTI who underwent endovascular or surgical revascularization. Revascularization was stratified by endovascular, autologous graft, and nonautologous graft approaches. The endpoint was a composite of major adverse limb events (MALE) and death. The study was composed of 66,153 patients including 10,125 autologous graft surgeries, 7,867 nonautologous graft surgeries, and 48,161 endovascular procedures.

Compared to the BEST-CLI Cohort 1, patients in the analysis were older, more often female, and had a greater burden of comorbidities. Endovascular operators for the study population versus BEST-CLI were less likely to be surgeons (55.9% vs 73.0%) and more likely to be interventional cardiologists (25.5% vs 13.0%). The risk of death or MALE in this cohort was higher with surgery (56.6% autologous grafts vs 42.6% BEST-CLI Cohort 1; 51.6% nonautologous grafts vs 42.8% BEST-CLI Cohort 2) but similar with endovascular (58.7% real-world vs 57.4% Cohort 1; 47.0% real-world vs 47.7%). Of those patients receiving endovascular treatment, major interventions occurred less frequently compared to the trial (10.0% real-world vs 23.5% Cohort 1; 8.6% real-world vs 25.6% Cohort 2).

“For critical limb ischemia (CLI), the key is ensuring timely access to vascular care,” commented Dr. Secemsky in the SCAI press release. “Although the BEST-CLI trial is important, it doesn’t fully capture the full range of CLI patients, including older patients with greater comorbidities. The findings from our study point to the need to individually tailor revascularization strategies based on patient risks, benefits, and preferences.”

Older CLI patients may not experience the same benefit with bypass surgery as observed in BEST-CLI where, at the time, fewer Medicare patients were enrolled in the trial, noted the analysis investigators in the SCAI press release.