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

Area of Science:

• Cardiovascular Research
• Vascular Medicine
• Health Disparities

Background:

• Peripheral artery disease (PAD) disproportionately affects women and underrepresented minorities (URMs).
• These demographic groups exhibit distinct responses to PAD treatments compared to non-Hispanic White males.
• There is a notable underrepresentation of women and URMs in existing PAD research.

Purpose of the Study:

• To assess baseline disease characteristics in a diverse population undergoing treatment for peripheral artery disease (PAD).
• To evaluate the enrollment strategies of the ELEGANCE registry in achieving representation of women and URMs.
• To identify potential disparities in PAD presentation and treatment indications across different sexes and racial/ethnic groups.

Main Methods:

• The ELEGANCE registry is a global, prospective, multi-center, post-market study.
• It aims to enroll at least 40% women and 40% underrepresented minorities (URMs).
• Inclusion criteria include age ≥18 years and treatment with a Boston Scientific drug-eluting device for peripheral lesions.

Main Results:

• Currently, 750 patients are enrolled, with 43.2% female and 47.3% URMs.
• Significant differences in Rutherford classification by sex (P=.019) and treatment indications by race/ethnicity (P=.003) were observed.
• Chronic limb-threatening ischemia was more prevalent in Black and Hispanic/Latino patients, while de-novo stenosis was higher in Asian patients.

Conclusions:

• The ELEGANCE registry data reveal disparities in baseline PAD characteristics based on sex and race/ethnicity.
• These differences may stem from factors such as delayed diagnosis, unmanaged comorbidities, and unequal access to care.
• Further research is needed to address these disparities and optimize PAD management for all patient populations.