Comparing BEST-CLI Participants with Patients Treated at a Tertiary Center Serving a Regional-Remote Population

Area of Science:

• Vascular Surgery
• Clinical Trials
• Health Equity

Background:

• The BEST-CLI trial provided key evidence for chronic limb-threatening ischemia (CLTI) revascularization.
• Restrictive eligibility criteria in BEST-CLI may limit its generalizability to diverse populations.
• Regional and remote populations often face unique challenges in accessing advanced medical care.

Purpose of the Study:

• To assess the applicability of BEST-CLI eligibility criteria to a regional Australian CLTI cohort.
• To compare outcomes between patients eligible and ineligible for the BEST-CLI trial.
• To highlight potential disparities in clinical trial access for rural and remote patients.

Main Methods:

• Retrospective evaluation of 388 CLTI patients treated at a tertiary vascular center.
• Application of BEST-CLI eligibility criteria by two independent vascular surgeons.
• Comparison of primary outcomes (mortality, major adverse limb events) using adjusted Cox proportional models.

Main Results:

• 71.4% of patients were ineligible for BEST-CLI, with ineligibility linked to greater distance from the center and rurality.
• Ineligible patients resided significantly further from the tertiary center (median 225.6 km vs 73.1 km).
• BEST-CLI eligible patients demonstrated a significantly lower risk of adverse outcomes (aHR: 0.53, p<0.001).

Conclusions:

• Strict BEST-CLI criteria exclude many rural/remote CLTI patients who experience worse outcomes.
• Trial findings may not be generalizable to regional populations due to these exclusions.
• There is a need for relevant benchmarks and strategies to improve clinical trial access and address inequities.