Representativeness of Peripheral Artery Disease Randomized Clinical Trials Supporting Current Guidelines

Area of Science:

• Cardiovascular Medicine
• Clinical Trials Methodology
• Health Disparities

Background:

• Peripheral artery disease (PAD) disproportionately affects women, older adults, and racial/ethnic minorities.
• Current PAD guidelines are based on evidence from randomized controlled trials (RCTs).
• The demographic representation within these pivotal RCTs is not well-established.

Purpose of the Study:

• To assess the representation of women, older adults, and racial/ethnic minorities in RCTs supporting current PAD guidelines.
• To compare trial demographics with PAD prevalence data in affected populations.

Main Methods:

• Systematic review of all PAD-specific RCTs cited in the latest American Heart Association/American College of Cardiology lower extremity PAD guidelines.
• Data extraction on participant demographics including sex, age, and race/ethnicity.
• Pooled analysis of demographic proportions and comparison with epidemiological data.

Main Results:

• 78 RCTs representing 101,359 patients were included.
• Women comprised 33% of trial participants, compared to 57.5% in US PAD epidemiological studies.
• The mean age of participants was 67.4 years; 29.4% of the global PAD population is over 70.
• Race/ethnicity data were reported in only 27% of the included studies.

Conclusions:

• RCTs underpinning current PAD guidelines underrepresent women and older adults.
• Racial and ethnic minority groups are underreported in PAD research.
• The limited generalizability of trial evidence may impact the care of diverse patient populations with PAD.