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Comparing BEST-CLI Participants with Patients Treated at a Tertiary Center Serving a Regional-Remote Population
Shivshankar Thanigaimani1, David Sun2, Oh Sung Choy2
1Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia.
Insights
The BEST-CLI trial
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.
Background:
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.
Methods:
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.
Results:
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).
Conclusion:
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.
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