Representation of Older Adults and Women in Randomized Trials of Noninvasive Imaging for Chest Pain.

Background: Noninvasive imaging is widely used both for initial diagnosis and to guide management of ischemic heart disease. Older adults and women with ischemic heart disease may have different responses to imaging as well as to treatments and outcomes that follow compared with younger adults and men. We aimed to study the representation of older adults and women in randomized controlled trials of noninvasive imaging among patients with acute and stable chest pain.

Methods: We conducted a systematic search across PubMed, ClinicalTrials.gov, and guidelines to identify randomized controlled trials of noninvasive imaging-guided diagnosis and management for ischemic heart disease that were published between 2002 and 2023. Participation-to-prevalence ratio (PPR) was estimated for women and age subgroups of <65, 65 to 74, ≥75 years. PPR of <0.8, 0.8 to 1.2, and >1.2 indicated underrepresentation, appropriate representation, and overrepresentation, respectively.

Results: Among 53 randomized controlled trials, age and sex breakdown were available in 21 (n=35 503) and 53 (n=55 893) trials, respectively. The median age across all trials was 57.4 years (interquartile range, 55.0-60.2). Participants aged <65 years were overrepresented with a median PPR of 2.13 (interquartile range, 1.73-2.43), whereas those aged 65 to 74 years and ≥75 years were underrepresented with median PPRs of 0.74 (interquartile range, 0.56-0.83) and 0.21 (interquartile range, 0.11-0.33), respectively. Women were adequately represented with a median PPR of 1.2 (1.06-1.32).

Conclusions: Although women were appropriately represented, adults ≥65 years, especially those ≥75 years, were underrepresented in these trials. Future randomized controlled trials on chest pain imaging should target enrollment of older adults to ensure generalizability of results to this population.