A new analysis of treatment outcome for chronic limb-threatening limb ischemia (CLTI) was presented today as a recent clinical paper at the Society for Cardiac Angiography and Interventions (SCAI) 2023 Scientific Sessions. Following the initial results of the BEST-CLI (Best Endovascular Versus Best Surgical Treatment for Patients with Critical Limb Ischemia) trial in 2022 finding that surgical intervention is superior to endovascular revascularization, questions remain about the extent of the cohort of patients enrolled. , the extent to which the specialization of physicians who perform procedures is compared to the broader division of US specialists performing peripheral procedures, and whether outcome rates are similarly observed in clinical practice among Medicare beneficiaries.
CLTI is associated with poor long-term outcomes and a decrease in quality of life. The BEST-CLI trial compared two treatment options for CLTI, vascular revascularization and surgical bypass to understand which approach produces better outcomes. While the study found surgical revascularization to be preferable, the generalizability of this study to a clinical population with CLTI was not evaluated.
The new study sought to analyze a broader clinical cohort by identifying all 2016-2019 Medicare beneficiaries ages 65-85 with a diagnosis of CLTI who underwent endovascular or surgical revascularization. Vascular reconstitution was divided by endovascular graft and non-autologous graft. The end point was a composite of major adverse events of the limb (male) and death.
66,153 patients were included in this study (10,125 autografts; 7,867 non-autografts; 48,161 intravascular). Compared with BEST-CLI Cohort 1, patients were older, predominantly female and had a higher burden of comorbidities. Vascular workers in the study population versus the 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 mortality in this group was higher with surgery (56.6% autologous grafts vs 42.6% BEST-CLI Cohort 1; 51.6% non-autologous grafts vs 42.8% BEST-CLI Cohort 2) but similar with the endovascular group (58.7% worldwide). real) versus 57.4% of the first group; 47.0% in the real world vs. 47.7%). Among those receiving endovascular treatment, major interventions occurred less frequently than in the trial (10.0% real-world vs 23.5% cohort 1; 8.6% real-world vs 25.6% cohort 2).
For critical ischemia of the extremities, the key is to ensure timely access to vascular care. Although important, the BEST-CLI trial does not capture the full range of CLI patients, including older patients with larger comorbidities. The findings of our study point to the need to individually tailor revascularization strategies based on the patient’s risks, benefits, and preferences.”
Eric A. Secemsky, MD, MSc, FSCAI, director of Vascular Intervention, Beth Israel Deaconess Medical Center in Boston, MA, and study leader
The authors note that older CLI patients may not experience the same benefit from bypass surgery as was observed in the BEST-CLI since at the time, fewer Medicare patients were enrolled in the trial.