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

BACKGROUND: Noninvasive imaging is widely used for both initial diagnosis and guided management of ischemic heart disease. Older adults and women with ischemic heart disease may have different responses to imaging and subsequent treatment outcomes compared to 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 age subgroups of <65, 65 to 74, ≥75 years, and women. 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 <65 years of age were overrepresented with a median PPR of 2.13 (interquartile range, 1.73-2.43), whereas those 65 to 74 years and ≥75 years of age 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 involving imaging for chest pain should target enrollment of older adults to improve generalizability of results to this population.

Duke Scholars

Author Karen Patton Alexander Medicine, Cardiology