New Analysis of Critical Limb-Ischemia Patients Underscores Need for Tailored Treatment Options

Late-Breaking Clinical Research Results Announced at SCAI Scientific Sessions 2023

BOSTON - Eric A. Secemsky, MD, MSc, FSCAI, director of Vascular Intervention at Beth Israel Deaconess Medical Center (BIDMC) presented a new analysis of clinical trial data evaluating chronic limb-threatening ischemia (CLTI) treatment outcomes as late-breaking clinical research by at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.

CLTI is associated with poor long-term outcomes and a reduction in quality of life. The BEST-CLI trial compared two CLTI treatment options, endovascular revascularization and surgical bypass to understand which approach leads to better outcomes. Initial results of the BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia) trial in 2022 found surgical intervention superior to endovascular revascularization. However, questions remained regarding the generalizability of this study to the real-world clinical population with CLTI as well as the physicians who performed the procedures.

The new study led by Secemsky sought to analyze a broader clinical population by identifying all Medicare beneficiaries aged 65-85 years with a diagnosis of CLTI who underwent endovascular or surgical revascularization between 2016-2019. Revascularization was stratified by endovascular, autologous graft, and nonautologous graft. The endpoint was a composite of major adverse limb events (MALE) and death.

“For critical limb ischemia, the key is ensuring timely access to vascular care,” said Secemsky, who is also an assistant professor of medicine at Harvard Medical School. “Although the BEST-CLI trial is a critically important trial for the vascular field, it is important to understand the applicability of these results to patients with CLTI who were not generally enrolled, including older patients with greater comorbidities. Our study’s findings point to the need to individually tailor revascularization strategies based on patient risks, benefits and preferences.”

Secemsky and colleagues included data from 66,153 patients in this study (10,125 autologous graft; 7,867 nonautologous graft; 48,161 endovascular). Compared to BEST-CLI Cohort 1, these patients were older, more often female and had a greater burden of comorbidities.

Additionally, endovascular operators for the study population versus BEST-CLI were less likely to be surgeons (56 percent vs 73 percent) and more likely to be interventional cardiologists (26 percent vs 13 percent).

The risk of death or MALE in this cohort was higher with surgery (57 percent autologous grafts vs 43 percent BEST-CLI Cohort 1; 52 percent nonautologous grafts vs 43 percent BEST-CLI Cohort 2) but similar with endovascular (59 percent real-world vs 57 percent Cohort 1; 47 percent real-world vs 48 percent Cohort 2). Of those receiving endovascular treatment, major interventions occurred less frequently compared to the trial (10 percent real-world vs 24 percent Cohort 1; 9 percent real-world vs 26 percent Cohort 2). The authors note that older CLI patients may not experience the same benefit with bypass surgery as observed in BEST-CLI.

This press release was adapted from the Society for Cardiovascular Angiography & Interventions.