Patients excluded from BEST-CLI were more likely to undergo a major amputation at a single urban safety net hospital

BEST-CLI (Best Endovascular Versus Best Surgical Therapy for Patients with Critical Limb Ischemia) is the largest randomized clinical trial for chronic limb-threatening ischemia (CLTI). However, as with any randomized clinical trial, generalizability is a concern. Our aims were to determine and quantify reasons for trial exclusion in all patients who underwent revascularization for CLTI at a single urban safety net hospital and to compare outcomes after revascularization of patients who were not eligible for BEST-CLI with patients who were eligible.

All patients who underwent revascularization for CLTI from August 2014 to October 2019 at a single center were identified. Trial- and site-specific exclusion criteria were assessed, and patients were grouped by enrollment criteria. Demographics, comorbidities, preoperative medications, prior interventions, and outcomes were then compared between noneligible and eligible patient groups. Categorical variables were compared using Pearson's χ² tests. Normally distributed variables were compared via Student t tests and non-normally distributed variables were assessed using Mann-Whitney U tests. Kaplan-Meier curves were constructed for time-to-event analysis of outcomes.

Of the 159 patients who underwent revascularization, 17 (11%) met BEST-CLI enrollment criteria and 142 (89%) were ineligible. The primary reasons for exclusion were perceived patient ability to adhere to trial protocol (46%), which included patients who had planned follow-up elsewhere or were unable to adhere to follow-up appointments. A total of 36 patients (25%) were deemed at excessive risk for open bypass; 26 patients (18%) were limited by an institutional policy excluding patients with limited English proficiency. Seventy-nine patients (56%) met a single criterion for exclusion, 52 patients (37%) met 2 criteria, and 11 patients (8%) met 3 criteria. Compared with patients eligible for BEST-CLI, noneligible patients had a significantly greater 5-year major amputation rate (P = .02) and lower major reintervention rate (P = .01), but no difference in all-cause mortality (P = .63).

Most patients presenting with CLTI at an urban safety net hospital failed to meet the BEST-CLI enrollment criteria. Nonmedical factors played a role in the exclusion of more than one-half of these patients, which underscores the importance of accommodating these factors to better assess ideal management strategies in this hospital setting.