One-year mortality, cardiovascular and limb events in the BEST-CLI Registry of chronic limb threatening ischemia patients.

Background

Patients with chronic limb threatening ischemia (CLTI) are at risk for cardiovascular events, amputations, hospitalizations, and death. We aimed to describe 1-year outcomes of a broader, non-clinical trial cohort of CLTI patients at a subset of BEST-CLI trial sites.

Methods

The BEST-CLI Registry enrolled patients with CLTI from 40 BEST-CLI trial sites between 2019 and 2023. One-year rates of mortality, major adverse limb events (MALE), composite of mortality or MALE, and major adverse cardiovascular events (MACE) were reported and compared between key subgroups using multivariable analyses.

Results

Of 1,009 patients who enrolled in the BEST-CLI Registry, 34.5% were female and 28.1% were Black. Ischemic rest pain was present in 62.8% of patients and tissue loss in 74.2%. Over the course of a year, 38.9% of patients (95% CI 35.4-42.7%) experienced the composite of MALE or mortality: MALE occurred in 17.0% (95% CI 14.2-20.4%) and 25.6% (95% CI 22.3-29.1%) died. Major amputation occurred in 8.2% (95%CI 6.3-10.7%) and 20.6% (95% CI 17.1-24.8%) had any revascularization. MACE occurred in 27.3% of participants (95% CI 23.9-30.8%). There were no differences in outcomes between Black and White or female and male patients.

Conclusions

In this large, diverse cohort of CLTI patients, including those ineligible for revascularization, mortality and limb events were common at one year, and did not differ based on race or sex. Patients had higher clinical event rates compared to those published in the BEST-CLI trial. Further work is needed to understand the generalizability of BEST-CLI findings to real-world cohorts of CLTI.