Differences in Baseline Clinical Presentation of Peripheral Artery Disease by Gender and Race/Ethnicity: Analyses from the ELEGANCE Registry

Monday, March 6, 2023

1:12 PM – 1:24 PM

Location: Phoenix Convention Center, 221AB

Presenting Author(s)

Maureen Kohi, MD (she/her/hers)

Professor and Chair
University of North Carolina at Chapel Hill

Disclosure(s): Boston Scientific: ELEGANCE Trial Global PI (no direct funding) (Ongoing); SIR Foundation: Advisory Committee/Board Member (), Vice Chair (); VIVA: Advisory Committee/Board Member (), Board Member ()

Disclosure(s):

Maureen Kohi, MD: Boston Scientific: ELEGANCE Trial Global PI (no direct funding) (Ongoing); SIR Foundation: Advisory Committee/Board Member (), Vice Chair (); VIVA: Advisory Committee/Board Member (), Board Member ()

Purpose: The ELEGANCE Registry is collecting real-world data on clinical outcomes following endovascular treatment of Peripheral Artery Disease (PAD), with a target enrollment of ≥40% women and ≥40% underrepresented minorities (URMs). We present baseline clinical data for the first 579 patients, stratified by gender and race/ethnicity.

Materials and Methods: ELEGANCE is a global, open-label, prospective multi-center registry of atherosclerotic lesions associated with PAD treated with drug-eluting devices (DEDs); study design includes components to enhance enrollment of women and URMs. Data collected include sociodemographic, disease, and treatment characteristics. Inclusion criteria include age ≥18 years and treatment with any commercially available Boston Scientific Corporation DED marketed for peripheral vasculature lesions; exclusion criterion is life expectancy < 1 year. Comparisons across gender and race/ethnicity groups were by 2-sample t-test/1-way ANOVA (continuous variables) and Chi-square/Fisher’s exact test (categorical variables).

Results: Of the 579 patients enrolled (710 lesions), 241/579 (41.6 %) are female and 226/570 (39.6%) are URMs (117 [20.5%] Black/African Heritage, 55 [9.6%] Asian, 47 [8.2%] Hispanic/Latino, and 7 [1.2%] Other). Significant differences were found between females and males who presented with moderate (30.2% vs. 23.0%, respectively; p=0.026) or severe calcification (25.7% vs. 35.8%; p=0.003). Females had a higher frequency of Rutherford 4 classification compared to males (21.5% vs. 10.8%; p< 0.001). Claudication as indication for treatment was lower in Asian (61.1%) and Black (53.2%) patients compared to Caucasian (70.6%) and Hispanic (70.2%) patients (p=0.007); chronic limb-threatening ischemia was higher for Black (38.5%) and Hispanic (27.7%) patients compared to Caucasian (21.6%) and Asian patients (22.2%; p=0.005). De-novo stenosis was higher in Asian patients (95.0%) compared to Black, Caucasian, and Hispanic patients (71.1%, 69.2%, and 74.2%, respectively; p< 0.001). Mean lesion length was higher for Black patients (159.9mm) compared to Caucasian (139.7mm) and Hispanic (132.9mm) patients, and lower for Asian patients (115.8mm; p=0.033).

Conclusion: Differences were observed in baseline clinical presentation between gender and race/ethnicity groups potentially suggesting variability in time to diagnosis, treatment decision making, early access to care. Through its emphasis on diversity, ELEGANCE will help to improve clinical decision making and outcomes for patients treated with DEDs.