Representation of Women in Atrial Fibrillation Ablation Randomized Controlled Trials: Systematic Review

Area of Science:

• Cardiovascular Medicine
• Clinical Trials
• Sex Differences in Health

Background:

• Sex disparities in cardiovascular disease research are a recognized issue.
• Previous studies have indicated potential underrepresentation of women in cardiovascular randomized controlled trials (RCTs).

Purpose of the Study:

• To assess the proportion of women participants in atrial fibrillation (AF) ablation RCTs.
• To identify potential risks associated with the underrepresentation of women in these trials.

Main Methods:

• Systematic literature search of PubMed and Embase for AF ablation RCTs published between 2015 and 2022.
• Analysis of participant demographics, focusing on the proportion of women.
• Comparison of participant characteristics between trials with higher and lower proportions of women.

Main Results:

• Out of 147 AF ablation RCTs (30,055 participants), only 10 trials achieved ≥50% female enrollment.
• The median proportion of women was 31.5%, with no significant change observed from 2015 to 2022.
• Trials with higher female enrollment included older patients with more hypertension but less persistent AF and smaller left atrial size.
• Exclusion criteria affected 28.57% of trials for pregnant/breastfeeding women and 4.1% for reproductive-age women.

Conclusions:

• Women remain underrepresented in contemporary AF ablation RCTs.
• Women enrolled in these trials often present with more comorbidities and less advanced AF.
• This underrepresentation and differing comorbidity profile limit the generalizability of trial findings to the broader population of women with AF.