Implementing methods in the ELEGANCE registry to increase diversity in clinical research

Objective: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research. Methods: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age $18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year. Results: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008). Conclusions: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.