Outcomes for Hispanic patients undergoing open bypass in BEST-CLI.

Objective: Hispanic patients have a higher prevalence of peripheral artery disease (PAD) risk factors, undergo revascularization at lower rates, and have higher rates of major amputation. This study compares outcomes after open surgical revascularization within the Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) Trial between Hispanic and non-Hispanic White patients.

Methods: In a secondary analysis of BEST-CLI, open surgical cohorts were combined (cohort 1, suitable single segment greater saphenous vein [n = 484]; cohort 2, lack of suitable single segment greater saphenous vein [n = 150]) and examined, by ethnicity, for the following 1-year outcomes: (1) above-ankle amputation, (2) major reintervention, (3) major adverse limb event (a composite of major amputation and major reintervention), and (4) survival. Cox regression models were constructed to determine the association between Hispanic ethnicity and selected endpoints after surgical bypass for patients enrolled in BEST-CLI.

Results: Of the 634 patients who underwent open surgical bypass, 528 (83.3%) were non-Hispanic White (White) and 106 (16.7%) were Hispanic. Compared with White patients, Hispanic patients were younger (64.6 ± 8.6 years vs 68.5 ± 9.6 years; P < .001), had a higher proportion of diabetes (91.5% vs 66.3%; P < .001), end-stage renal disease (15.1% vs 6.8%; P = .005), and were more often never smokers (44.3% vs 16.2%; P < .001). Preoperative ankle-brachial index was higher among Hispanic patients (0.7 ± 0.4 vs 0.5 ± 0.3; P < .001). After controlling for age, sex, diabetes, end-stage renal disease, smoking history, infrapopliteal disease, Wound Ischemia foot Infection stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (adjusted hazard ratio [aHR], 0.67; 95% confidence interval [CI], 0.30-1.48), major reintervention (aHR, 0.81; 95% CI, 0.35-1.87), major adverse limb event (aHR, 0.64; 95% CI, 0.34-1.21), or survival (aHR, 0.69; 95% CI, 0.42-1.13) 1 year after surgical bypass.

Conclusions: Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in BEST-CLI. Future PAD clinical trials should capture metrics of access to care, and timeliness of care for assessing risk of disparate outcomes among PAD populations thought to be at higher risk based on epidemiological and retrospective studies.