ELEGANCE Study Seeks to Improve Diversity in Peripheral Artery Disease Trials

November 4, 2022—Women and underrepresented minorities (URMs) are infrequently included in peripheral artery disease (PAD) trials, despite the high prevalence of PAD these groups. To address this disparity, ELEGANCE—a global, nonrandomized, open-label, prospective, multicenter registry—is actively collecting real-world data on outcomes after endovascular treatment of PAD, with an emphasis on enrolling diverse patients treated with drug-eluting devices (DEDs).

Maureen P. Kohi, MD, presented data from ELEGANCE during the third of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, ELEGANCE aims to enroll at least 40% each of women and URMs. Enrolled patients will be followed up to 5 years post–index treatment. Inclusion criteria include age ≥ 18 years, written informed consent, and treatment with any commercially available Boston Scientific Corporation DEDs marketed for lesions in peripheral artery circulation.

As summarized in the VIVA Foundation press release, Dr. Kohi reported that 579 patients (710 lesions) have been enrolled across 46 activated sites in the United States, China, Germany, and Thailand as of July 28, 2022. Mean age is 69.6 years (SD ± 9.7 years); 241 (41.6 %) are female and 235 (40.6%) are URMs.

Of these URM patients, 117 (20.2%) are Black or of African heritage, 55 (9.5%) are Asian, and 47 (8.1%) are Hispanic/Latino.

Comorbidities and risk factors include current smoking (56 patients; 27.4%) or past smoking (292; 51.3%); type 2 diabetes mellitus (305; 52.7%); and history of hyperlipidemia (468; 82.2%) and/or history of hypertension (515; 90.5%) requiring medication.

Treatment indications include claudication (370 patients; 66.3%) and chronic limb-threatening ischemia (143; 25.6%). Median lesion length was 100 mm (interquartile range, 60-200 mm).

Of 710 treated lesions, 513 (72.7%) were de novo and 193 (27.3%) were restenotic. Calcification was moderate or severe in 178 patients (25.3%) and 225 patients (32.0%), respectively. Among the 538 patients with available Rutherford classification at baseline, 204 (37.9%) were ≥ class 4.

Dr. Kohi concluded that by emphasizing diversity of patients studied, ELEGANCE will improve therapeutic decision-making and clinical outcomes for the management of PAD with DEDs in all populations, including those uncommonly included in PAD trials.