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

The BEST-CLI trial established the first large-scale evidence for revascularization of chronic limb-threatening ischemia (CLTI), but its restrictive eligibility criteria may limit applicability to regional-remote populations.

We retrospectively evaluated BEST-CLI eligibility in a consecutive cohort of patients treated for CLTI at a tertiary vascular center serving the North Queensland regional and remote Australian population. Trial criteria were applied independently by 2 vascular surgeons. The primary outcome was the composite of all-cause mortality and major adverse limb events and was compared by eligibility and procedure type using risk-factor adjusted Cox proportional models.

Patients (n = 388) were followed for a median of 2.4 (interquartile 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 center 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 than ineligible patients (adjusted hazard ratio: 0.53, 95% confidence intervals: 0.39, 0.71, P < 0.001).

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 generalizable to regional populations, underscoring the need for relevant benchmarks and strategies to address inequities to clinical trial access.