Representativeness of Peripheral Artery Disease Randomized Clinical Trials Supporting Current Guidelines

Abstract

Women, older adults, and racial/ethnic minorities are differentially affected by lower extremity peripheral artery disease (PAD), yet their representation in randomized controlled trials (RCTs) on which current PAD guidelines are based is not known. We therefore evaluated whether RCTs supporting most recent American Heart Association/American College of Cardiology lower extremity PAD guidelines proportionately represent the spectrum of demographic groups affected by PAD. All PAD-specific RCTs cited in the guidelines were included. From 409 references, 78 RCTs were included, representing 101,359 patients. Pooled proportion of women enrolled was 33% (95% confidence interval 29% to 37%) versus 57.5% in US PAD epidemiologic studies. Pooled mean age of all trial participants was 67.4 ± 0.8 years, in comparison with global estimates of PAD, in which 29.4% of the global population with PAD is >70 years old. Race/ethnicity distribution was reported in 27% of studies (21 of 78). In conclusion, in trials supporting current PAD guidelines, women and older adults patients are underrepresented, and different race and ethnic groups are underreported across the spectrum of studies. Underrepresentation of these groups differentially affected by PAD may limit the generalizability of the evidence supporting PAD guidelines.