Examination of Race and Ethnicity After Revascularization in the BEST-CLI Trial.

Abstract

We examined the Best Endovascular versus Best Surgical Therapy in patients with chronic limb threatening ischemia (BEST-CLI) Trial to determine if ethnoracial disparities persist in the setting of a contemporary randomized controlled trial. Designed as a comparative effectiveness trial evaluating surgical bypass against endovascular therapy in adults with between 2014-2019, this secondary analysis examines Hispanic, Black, and White participants. Exposure variable is ethnoracial identity and primary outcome is major adverse limb events (MALE) or all-cause death (referred to as MALE-free survival). Secondary endpoints include index limb major amputation, major reintervention, mortality, MALE, major adverse cardiac events (MACE). Among 1677 patients (median follow-up 2.4 years [IQR 1.0-3.5]), 350(20.9%) identified as Black and 225(13.4%) as Hispanic. Compared to White patients, Black and Hispanic patients were younger, more likely to be female, have diabetes and/or dialysis dependence (ESKD), and present with advanced disease severity. There were no differences in preoperative guideline directed medical therapy. On univariable analysis, compared to White patients, Black and Hispanic patients had increased likelihood of major amputation. There were no differences noted for MALE-free survival, major reintervention, mortality, MALE, or MACE. After controlling for age, sex, diabetes, ESKD, smoking history, prior revascularization, presenting WIfI stage, anatomic segment of disease treated, revascularization method, there was no association between ethnoracial identity and MALE-free survival, amputation, major reintervention, mortality, MALE, or MACE. Disparities are mitigated when evidence-based care (e.g., appropriate surgical conduits, early access to care) is provided to Black and Hispanic patients in the BEST-CLI trial.