A Little ELEGANCE in the Study of Under-Represented Patients

First-time data from an important study of the real-world treatment of lesions in the peripheral vasculature was previewed on Tuesday afternoon by Marianne Brodmann, Head of the Division of Angiology at the Medical University of Graz, Austria. As part of the international steering committee for the ELEGANCE registry, Professor Brodmann was asked to share some of the exciting results from an interim analysis of their registry data.

ELEGANCE (Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature) aims to collect real-world data on peripheral arterial disease (PAD) patients treated with drug-eluting devices. It is an international, non-randomized, prospective, open-label, multi-centre post-market registry evaluating the Ranger paclitaxel-coated percutaneous transluminal angioplasty balloon catheter, and ELUVIA drug-eluting vascular stent system (Boston Scientific). Ultimately, the researchers hope to enroll 5000 cases.¹

Importantly, Professor Brodmann’s group is specifically focusing on enrolling patients from groups typically underrepresented in PAD research. “Our goal is to enroll at least 40% women and 40% underrepresented minority patients,” she told LINC Today. “We took a very careful approach in designing the ELEGANCE registry to ensure that patients who are typically underrepresented in PAD research were well represented.”

Professor Brodmann shared initial results in underrepresented groups treated with the Ranger drug-coated balloon (DCB). So far, enrollment has been educational. “We are thrilled to report that our enrollment targets for underrepresented populations are exceeding our goals,” she said, reporting that amongst the 566 patients enrolled thus far who were treated with the Ranger DCB, 45.3% are women and 44.7% are underrepresented minority patients, i.e. those identifying as other than non-Hispanic White. “We are seeing significant differences in baseline medical, disease, and lesion characteristics between these groups,” she added.

The group is currently collecting post-treatment outcome data on these patients, so it’s unclear how patient outcomes differ amongst those treated with the Ranger DCB. “That said, we can say that there are significant differences in clinical presentation of women and minority patients,” she said. “These groups are presenting to us with a higher burden of atherosclerotic risk factors like smoking history, diabetes, and hyperlipidemia.”

The researchers are also seeing differences in lesion presentation itself. For example, Black patients have a longer mean lesion length at the time of treatment than their non-Hispanic White counterparts. Conversely, Asian patients are presenting with significantly shorter mean lesion length, but with a higher prevalence of moderate and severe calcification.

Crucially, Professor Brodmann said conducting a study able to uncover such important disparities could only be done intentionally. It was a conscious choice to select sites in diverse communities, to invite the participation of women and minority investigators, and to employ diversity training for study staff. Additionally, despite specifically selecting sites and physicians in areas known for higher rates of underrepresented populations, Professor Brodmann said establishing just who was seen was important too. “It was critical for us to work with the institutions to determine if they actually saw these underrepresented patients in their practice,” she said. 

“If they did not, we attempted to help establish referral pathways to help bring in those patients (such as providing site materials, referral letters and other methods). These challenges were discovered and addressed through individual discussions with sites to review their diversity and inclusion metrics.”

Professor Brodmann stressed that the approaches her group has used – to ensure that they intentionally choose diverse communities – could be replicated. “We would love to see some of these approaches employed in the design and development of future randomized controlled trials,” she said. 

Women and minority patients are chronically underrepresented in clinical research across myriad disease states, she said. “The issue of representation in clinical research at all levels – from investigators and study staff, to communities and patients – is a pressing one,” she said. “It is our sincere hope that ELEGANCE helps to provide answers to help close the gap in PAD disparities, and that it serves as an example for addressing health disparities for other conditions.”

Interim data from the ELEGANCE registry showing that differences in baseline clinical presentation could be observed between sex and racial/ethnic groups builds on previous research. “These results validate previous smaller studies which indicated that women and minority patients are disproportionately affected by PAD – not just in prevalence, but also in severity of disease,” she said. “We hypothesize that these differences suggest variability in time to diagnosis, treatment planning, and access to care.”

She concluded: “We are excited that the 1-year outcomes data are coming in from patients enrolled at the registry’s launch last year, and look forward to sharing interim analyses from those patients within the next year.”

REFERENCE
1. Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04674969; accessed May 2023.