Boston Scientific Shares Updates from Its ELEGANCE Registry

Boston Scientific reported an update from its ELEGANCE Registry, evaluating endovascular drug-eluting treatments for peripheral artery disease (PAD) – Eluvia and Ranger – in historically underrepresented patient groups.

12-month results from the registry’s first 500 patients demonstrate disparities that have been seen historically. Underrepresented populations and females have more advanced diseases than their Non-Hispanic White and male counterparts at the time of treatment. 

Study participants underwent peripheral drug-eluting device interventions with the Ranger paclitaxel-coated balloon and/or Eluvia paclitaxel-eluting stent (Boston Scientific, Marlborough, MA, USA), and through novel recruitment mechanisms, the study aims to enroll at least 40% women and 40% underrepresented racial and ethnic groups globally.

One-year outcomes of paclitaxel-based revascularization with the Ranger drug-coated balloon or the Eluvia drug-eluting stent demonstrate excellent clinical outcomes and positive patient experience in females and underrepresented racial/ethnic populations, regardless of these patients presenting a more advanced disease state.

Characteristics of the first 500 patients who completed a 12-month follow-up visit aligned with ELEGANCE enrollment objectives, with 41.6% female and 41.6% from underrepresented racial/ethnic populations. 

Patient characteristics and disease presentation differed among sex, race, and ethnicity groups. Females were significantly older than males on average and more likely to present with advanced Rutherford category 4-6 disease. All underrepresented population groups presented as Rutherford category 4-6 at a greater frequency than the non-Hispanic White group.

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, race, or ethnicity. The overall site-reported 12-month freedom from CD-TLR rate was 89.6%.

1-year outcomes of paclitaxel-based revascularization with the Ranger drug-coated balloon or the Eluvia drug-eluting stent suggest that excellent effectiveness and safety results may generalize to underrepresented patient groups.

This update was shared at VIVA and The VEINS 2024 in Las Vegas.