LB-6
Contextualizing the BEST-CLI Trial Results in Clinical Practice
Presenter
Eric Secemsky, MD, MSc, FSCAI, Beth Israel Deaconess Medical Center, Newton, MA
Eric Secemsky, MD, MSc, FSCAI, Beth Israel Deaconess Medical Center, Newton, MA, Venita Chandra, Stanford University, Stanford, CA, Joshua Beckman, MD, MSc, Vanderbilt University Medical Center, Nashville, TN, Sahil A. Parikh, MD, FSCAI, NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY, Robert Lookstein, MD, Icahn School of Medicine at Mount Sinai, New York, NY, Sanjay Misra, MD, Mayo Clinic College of Medicine and Science, Rochester, MN and Neel Butala, M.D., University of Colorado Anschutz Medical Campus, Denver, CO
Keywords: Critical Limb Ischemia/Chronic Limb-threatening Ischemia (CLT/CLTI), Peripheral Artery Disease (PAD) and Peripheral Vascular Disease (PVD)
Background
:
CLTI is associated with poor long-term outcomes. The BEST-CLI trial compared endovascular and open surgical revascularization for CLTI, but the generalizability of this study to the clinical population with CLTI has not been evaluated.
Methods:
All Medicare beneficiaries between 2016-2019 and aged 65-85 years with a diagnosis of CLTI who underwent endovascular or surgical revascularization were identified. Revascularization was stratified by endovascular, autologous graft (Cohort 1), and nonautologous graft (Cohort 2). The endpoint was a composite of major adverse limb events (MALE) and death
Results
:
66,153 patients were included in this study (10,125 autologous graft; 7,867 nonautologous graft; 48,161 endovascular). Compared to BEST-CLI Cohort 1, patients were older, more often female and had a greater burden of comorbidities (Table. 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 ICs (25.5% vs 13.0%). The crude 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% Cohort 2; Figure 1). Of those 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; Figure 2).
Conclusions
:
These results suggest that the findings of the BEST-CLI trial may not be applicable to the entirety of the real-world patients with CLTI undergoing revascularization.