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

Eric A Secemsky; Jay Giri; Marianne Brodmann; Yann Gouëffic; Weiguo Fu; Alexandra J Greenberg-Worisek; Michael R Jaff; Lee Kirksey; Maureen P Kohi

doi:10.1016/j.jvs.2023.08.131

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

J Vasc Surg. 2024 Jan;79(1):136-145.e3. doi: 10.1016/j.jvs.2023.08.131. Epub 2023 Sep 22.

Authors

Eric A Secemsky¹, Jay Giri², Marianne Brodmann³, Yann Gouëffic⁴, Weiguo Fu⁵, Alexandra J Greenberg-Worisek⁶, Michael R Jaff⁶, Lee Kirksey⁷, Maureen P Kohi⁸

Affiliations

¹ Department of Vascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA. Electronic address: esecemsk@bidmc.harvard.edu.
² Department of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA.
³ Division of Angiology, Medical University of Graz, Graz, Austria.
⁴ Vascular Center, Groupe Hospitalier Paris Saint Joseph, Paris, France.
⁵ Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
⁶ Peripheral Interventions, Boston Scientific Corporation, Marlborough, MA.
⁷ Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH.
⁸ Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.

PMID: 37742734
DOI: 10.1016/j.jvs.2023.08.131

Abstract

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.

Keywords: Clinical trials; Health disparities; Health equity; Patient engagement; Patient recruitment; Peripheral artery disease.

Publication types

Multicenter Study

MeSH terms

Asian
Black or African American
Drug-Eluting Stents*
Ethnicity*
Female
Hispanic or Latino
Humans
Male
Patient Selection*
Peripheral Arterial Disease* / surgery
Product Surveillance, Postmarketing
Prospective Studies
Racial Groups*
Registries
White