Comparing BEST-CLI participants with patients treated at a tertiary centre serving a regional-remote population

BACKGROUND: The BEST-CLI trial established the first large-scale evidence for revascularisation of chronic limb-threatening ischaemia (CLTI), but its restrictive eligibility criteria may limit applicability to regional-remote populations. METHODS: We retrospectively evaluated BEST-CLI eligibility in a consecutive cohort of patients treated for CLTI at a tertiary vascular centre serving the North Queensland regional and remote Australian population. Trial criteria were applied independently by two vascular surgeons. The primary outcome was the composite of all-cause mortality and major adverse limb events (MALE) and was compared by eligibility and procedure type using risk-factor adjusted Cox proportional model. RESULTS: Patients (n=388) were followed for a median of 2.4 (inter-quartile range 1.3, 3.9) years, and 277 (71.4%) of them were deemed ineligible for BEST-CLI. Ineligible patients lived significantly further from the tertiary centre than eligible patients (median 225.6 vs 73.1 km, p=0.038), with rurality significantly associated with ineligibility (p=0.011). BEST-CLI eligible patients had a significantly lower risk of primary outcome events compared with ineligible patients (adjusted hazard ratio: 0.53, 95% confidence intervals: 0.39, 0.71, p<0.001). CONCLUSIONS: The strict eligibility criteria in the BEST-CLI trial would have excluded many rural and remote patients with CLTI who have worse outcomes then eligible patients. Trial findings may not be generalisable to regional populations, underscoring the need for relevant benchmarks and strategies to address inequities to clinical trial access.