OBJECTIVE: Women and racial/ethnic minority groups have been shown to experience poor outcomes after endovascular aortic aneurysm repair (EVAR). One potential reason is the rare inclusion of these populations in initial phases of device development. The objective of this systematic review is to understand enrollment and outcome reporting by Sex and Race/Ethnicity in industry-funded EVAR device development trials.METHODS: MEDLINE, PubMed, and Embase, were searched from inception to January 2022 without language restrictions using the following terminology: "stent", "graft", "endograft", "device", "abdominal aortic aneurysm".CLINICALTRIALS: gov was also searched from inception to January 2022 for "abdominal aortic aneurysm." Two independent reviewers screened and extracted data. All phase I-III and post-market evaluation trials that included patients = 18 years of age, who underwent EVAR were assessed. Participation-to-prevalence ratios (PPR) were calculated to estimate representation of participants by sex and race/ethnicity in trials compared with their share of disease burden.RESULTS: Among the 4,780 retrieved articles, 55 industry-funded trials met inclusion criteria for this review. A total of 51 trials (93%) reported enrolment by sex/gender, and only 7 trials (13%) reported enrolment by race/ethnicity of the participants. A median of 19 (IQR 4.5, 51) women participants were recruited compared to 171 (IQR 57, 311.5) men, and 17 (IQR 7.5, 21.5) racial/minority patients were recruited compared to 241 (IQR 123, 463.5) White participants. Women represent 16.6% of the disease population, and the median PPR is 0.62 (IQR 0.42, 0.88), which has remained constant over time (Figure 1). None of the device trials reported outcomes based on sex/gender or race/ethnicity.CONCLUSIONS: This systematic review to highlights the disparities in recruitment and outcome reporting based on sex and race/ethnicity in EVAR device development trials. While most trials may be underpowered to study these differences, recent registry studies show differential outcomes based on sex and race/ethnicity of vascular patients. Therefore, it is imperative to include and report outcomes in these participants, starting from the initial device development phases to improve generalizability of device-use and understand sources of variation in device performance.
View details for DOI 10.1016/j.avsg.2022.09.059
View details for PubMedID 36272665