Recruitment And Outcome Reporting For Women And Minorities In Stent Device Development Trials For Endovascular Abdominal Aortic Aneurysm Repair

Women and minority groups, like Black and Hispanic patients, have been shown to experience poor outcomes after endovascular aortic aneurysm repair (EVAR). One potential reason is the low involvement of these populations in initial phases of device development. The objective of this systematic review is to understand enrollment and outcome reporting for women and underrepresented minorities in industry-funded device development trials for EVAR. Medline, PubMed, and Embase were searched from inception to December 2020 without language restrictions using the following terminology: Stent, graft, endograft, device, abdominal, aortic aneurysm. Clinicaltrials.gov was also searched from inception to December 2020 for studies on abdominal aortic aneurysm. Two independent reviewers screened and extracted data from articles. All clinical trials (phase I-III and post-market evaluation) that included patients ≥18 years of age, who underwent EVAR were included. The participation-to-prevalence ratio (PPR) is calculated by dividing the percentage of participants in the trial population by the percentage of people with the disease. The PPR was calculated for each study, and trends over time for PPR of women participants is provided in the Fig. Of the 4780 retrieved articles, 58 industry-funded trials were included in this review. A total of 53 trials (91%) reported enrollment by sex/gender, and only seven trials (12%) reported enrollment by race/ethnicity of the participants. Among these trials, a median number of 19 (interquartile range [IQR], 4-51) female participants compared with 167 male (IQR, 57-298) participants and 14 participants (IQR, 8-21) from non-white minority groups compared with 241 white (IQR, 123-464) counterparts were recruited. Considering that the prevalence of women in the disease population is 16.6%, the median PPR is 0.62 (IQR, 0.42-0.88) and has stayed fairly constant over time (Fig). None of the trials reported outcomes like mortality and reintervention rate based on sex/gender or race of the participants. This is the first systematic review to highlight the disparity in recruitment and outcome reporting for women and minorities in aortic device development trials. Although these trials may have been underpowered to study these differences, recent observational studies from registries show differential if not worse outcomes for women and minority vascular patients. Therefore it is imperative to include these populations and report outcomes in the groups, starting from the initial device development phases to improve generalizability of device use and understand sources of variation in device performance.