Abstract
BACKGROUND: While female sex has historically been associated with worse outcomes following surgical aortic valve replacement, the evidence regarding sex-related differences after transcatheter aortic valve implantation (TAVI) remains inconclusive. Given that women are more frequently referred for TAVI, clarifying the role of sex in procedural outcomes is clinically relevant. OBJECTIVES: To systematically evaluate and summarise randomised clinical trial (RCT) evidence comparing TAVI outcomes between women and men. METHODS: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in PROSPERO (CRD42024510202). PubMed, EMBASE and Web of Science were searched for English-language RCTs up to 1 July 2024. Studies comparing TAVI outcomes by sex were included. The primary outcome was all-cause mortality. Secondary outcomes included cardiovascular mortality, stroke or transient ischaemic attack (TIA), major bleeding and permanent pacemaker implantation (PPI). Pooled ORs were calculated using Mantel-Haenszel random-effects models. RESULTS: 14 RCTs with a total of 15 225 participants were included. No overall difference in all-cause mortality was observed between sexes (OR: 0.83; 95% CI 0.65 to 1.06), though a significant protective effect for female sex was found among intermediate-risk patients (OR: 0.64; 95% CI 0.49 to 0.84; I²=0%). Women had a significantly higher risk of major bleeding (OR: 1.35; 95% CI 1.21 to 1.52; I²=15%). No significant sex-based differences were identified in cardiovascular mortality (OR: 0.98), stroke/TIA (OR: 0.96) or PPI (OR: 1.05). CONCLUSION: Female sex was associated with a lower all-cause mortality among intermediate-risk patients undergoing TAVI, but also with a higher overall risk of major bleeding. These findings suggest the need for further investigation into sex-related anatomical and procedural factors. PROSPERO REGISTRATION NUMBER: CRD42024510202.