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

Abstract

Objectives: Hispanic patients have 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 versus 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 the BEST-CLI trial, open surgical cohorts were combined (Cohort 1: suitable single segment greater saphenous vein (SSGSV), N=484; Cohort 2: lack of suitable SSGSV, N=150) and examined, by ethnicity, for the following 1-year outcomes: 1) above ankle amputation; 2) major reintervention; 3) major adverse limb event (MALE, 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 the BEST-CLI trial.

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 to White patients, Hispanic patients were younger (64.6±8.6 vs 68.5±9.6, p<0.001), had a higher proportion of diabetes (91.5% vs 66.3%, p<0.001), end-stage renal disease (ESRD) (15.1% vs 6.8%, p=0.005), and were more often never smokers (44.3% vs 16.2%, p<0.001). Preoperative ankle brachial index was higher among Hispanic patients (0.7±0.4 vs 0.5±0.3, p<0.001). After controlling for age, sex, diabetes, ESRD, smoking history, infrapopliteal disease, WIfI Stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (aHR 0.67; 95% CI 0.30-1.48), major reintervention (aHR 0.81; 95% CI 0.35-1.87), MALE (aHR 0.64; 95% CI 0.34-1.21), or survival (aHR 0.69; 95% CI 0.42-1.13) one year after surgical bypass.

Conclusions: Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in the BEST-CLI Trial. 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 epidemiologic, and retrospective studies.