Diversity and Inclusion in PAD: The ELEGANCE Registry

During a Town Hall session at ISET 2022, Dr. Maureen Kohi of the University of North Carolina at Chapel Hill discussed the racial and ethnic disparities in patients with critical limb ischemia (CLI) and peripheral arterial disease (PAD). Black American patients fare much worse than their Caucasian patients when it applies to CLI and extremity amputation.

“Despite the high prevalence of PAD in women and underrepresented minorities, clinical trials rarely include significant size cohorts,” Dr. Kohi said. “Given the heterogeneity of PAD patient presentation, there is still a need to better understand how PAD treatments affect such cohorts.” Data about these populations doesn’t exist, however—which is what the Drug-ELuting REGistry: ReAl World Treatment of LesioNs in the Peripheral VasCulaturE, or ELEGANCE, Registry is trying to change. The objective of the Registry is to prospectively collect real-world data on the treatment of PAD with a focus on efforts to screen and enroll diverse groups that have been previously underrepresented in PAD research. The goal of this prospective, multicenter, global single-arm, nonrandomized open registry is to enroll up to 5,000 subjects at up to 100 global centers, treated with drug-eluding devices.

“This registry aims to collect the data that we need to be able to intelligently answer questions about quality of life and healthcare utilization as it applies to women and underrepresented minorities, among others,” Dr. Kohi explained. “We're making a bold promise that we intend to enroll at least 40% women. That's never been done. And up to 40% underrepresented minorities, which also has not been done.” To do this, a diverse group of global physicians make up the steering committee, including men and women in a variety of specialties who treat patients with PAD: interventional radiologists, interventional cardiologists, and vascular surgeons, among others.

Unique efforts are being made to include a diverse group of patient populations in the ELEGANCE Registry. “We're targeting media campaigns to drive study awareness, to recruit more patients into the clinical trial,” Dr. Kohi said. “And at each site we have teams that are present to help with enrollment, to overcome barriers, and to educate the site directors and the individuals at the specific sites to improve inclusion of patients and diverse patients. We are working to close the gap initiative to try to improve the inclusion of diverse patients in our registry.”

So far, 250 patients have been enrolled in the registry, and already they’re above the target of 40% women. More than 30% underrepresented minorities are enrolled, which is closing in on the 40% target. “To make a difference, we need to be different,” said Dr. Kohi. “I think ELEGANCE is an excellent example of the partnership between industry and physicians, as we aim to be a diverse multidimensional source of real-world data in PAD treatment outcomes. By emphasizing diversity and inclusion in clinical trial leadership and patient enrollment, we can expand patient representation in PAD trials and improve clinical decision making and outcomes.”