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

Abstract

BACKGROUND: Sex inequality in randomized controlled trials (RCTs) related to cardiovascular disease has been observed. This study examined the proportion of women enrolled in atrial fibrillation (AF) ablation RCTs and the potential risks of underrepresentation of women. METHODS AND RESULTS: We systematically searched PubMed and Embase for AF ablation RCTs published from 2015 to 2022. Participant characteristics were compared among trials with higher and lower proportions of women. Of 147 AF ablation RCTs (30,055 participants), only 10 trials had enrolled women ≥50% of the total participants. Additionally, 42 trials (28.57%) excluded pregnant/breastfeeding women; 6 (4.1%) excluded reproductive-age women without reliable birth control. The proportion of women in AF RCTs ranged from 9% to 71% (median 31.5%), whereas the median proportion of men was 67.7%. The rate of women included in the trials was stable from 2015 to 2022 (P=0.49). Study characteristics, including funding source, showed no correlation with the rate of inclusion of women. RCTs with a higher proportion of female participants enrolled older patients with AF, had a higher prevalence of hypertension but less persistent AF, and smaller left atrium size (P<0.05 for all). Biological sex was evaluated as a risk factor or in a subgroup analysis in 28 RCTs; 10.7% of these trials observed the implication of sex on their results. CONCLUSION: Women were underrepresented in contemporary AF ablation RCTs. Additionally, women enrolled in AF RCTs were likely to have more comorbidities but less advanced AF, limiting the applicability of the results to women with AF.