PAD registry meeting enrollment goals for women, patients from underrepresented groups
A registry of drug-eluting devices for the treatment of patients with peripheral arterial disease is meeting its enrollment goals for women and patients from historically underrepresented backgrounds, researchers reported at VIVA 22.
“Despite the high prevalence of peripheral arterial disease in women and underrepresented minorities, these groups are infrequently studied in PAD clinical trials,” Maureen P. Kohi, MD, FSIR, FCIRSE, FAHA, Ernest H. Wood Distinguished Professor and chair of the department of radiology at the University of North Carolina at Chapel Hill, said during a presentation. “ELEGANCE is an innovative global registry building real-world evidence and assessing outcomes in patients treated with drug-eluting products, with an emphasis on previously underrepresented patient populations. Our goal, which is quite bold, is to enroll no fewer than 40% women and no fewer than 40% [underrepresented minorities].”
The registry includes real-world patients with lesions in their peripheral circulation treated with a drug-eluting stent (Eluvia, Boston Scientific) or a drug-coated balloon (Ranger, Boston Scientific).
The focus on recruiting women and people from underrepresented backgrounds “is done through very intense communication with investigators from each site to make specific efforts to screen and enroll women and diverse patients to represent those not previously included in PAD trials,” Kohi said.
The goal is to recruit 1,500 to 5,000 patients to collect data on clinical outcomes, adverse events, health economics, patient preferences and other topics, and to follow 250 of those patients for performance on the 6-minute walk test, quality of life surveys and health care utilization, she said, noting that patients will be followed for 5 years.
“We are very strategic about our site selection and about the [principal investigators] at those sites,” she said. “Ample diversity and inclusion materials are offered to each site. Site-level partnerships and discussions are had on how to increase the recruitment of women and underrepresented minorities in this trial. It is different, because a lot of women and [underrepresented minorities] have distrust of the clinical trial world. There are specific strategies to tackle that mistrust.”
As of July, the registry had 579 patients with 710 lesions from 46 sites. Of those patients, the mean age is 70 years, 41.6% are women and 40.6% are from underrepresented backgrounds (about half of whom are Black or from African heritage), exceeding the goal of 40% for both, Kohi said. About two-thirds presented with claudication and most of the rest with chronic limb-threatening ischemia, she said.
In addition, 27.3% of lesions had restenosis and 32% had severe calcification, she said.
Of the 538 patients with available Rutherford classification, 37.9% were class 4 or higher, she said.
“By emphasizing diversity of patients studied ... ELEGANCE aims to improve therapeutic decision-making and clinical outcomes for the management of PAD with drug-eluting devices in all populations, including those uncommonly studied in PAD trials,” Kohi said during the presentation.
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Kohi MP, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).