ELEGANCE Registry Studies Drug-Eluting Device Treatment of PAD in Underrepresented Minorities and Women

November 5, 2024—The ELEGANCE registry, which is focused on historically underrepresented minorities and women, analyzed endovascular treatment of peripheral artery disease (PAD) with drug-eluting devices. The 12-month clinical results from the first 500 patients in the registry are available.

Jay Giri, MD, presented the ELEGANCE findings in the fourth and final late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, the ELEGANCE registry study participants underwent peripheral device interventions with the Ranger paclitaxel-coated balloon and/or Eluvia paclitaxel-eluting stent (both Boston Scientific Corporation). Through novel recruitment mechanisms, the study aims to enroll at least 40% women and 40% underrepresented racial and ethnic groups globally.

Characteristics of the first 500 patients who completed a 12-month follow-up visit aligned with ELEGANCE enrollment objectives, with 41.6% female patients and 41.6% from underrepresented racial/ethnic populations. Patient characteristics and disease presentation differed among sex and race/ethnicity groups. Females were significantly older than males on average and more likely to present with advanced Rutherford category 4 to 6 disease. All underrepresented population groups presented as Rutherford category 4 to 6 at a greater frequency than the non-Hispanic White group.

Dr. Giri reported that despite differing and advanced disease characteristics, the 12-month above-ankle amputation incidence was low at 0.8%; reintervention rates were low and did not differ significantly by sex or race and ethnicity. The overall site-reported 12-month freedom from clinically driven target lesion revascularization rate was 89.6%.

Although the PAD presentation of the diverse patients enrolled in ELEGANCE reflects significant disparities, 1-year outcomes of paclitaxel-based revascularization with the Ranger Drug-Coated Balloon or Eluvia Drug-Eluting Stent suggest that excellent effectiveness and safety results may generalize to underrepresented patient groups, concluded the findings in the VIVA24 press release.