What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: transcatheter aortic valve replacement (n=11310). Intervention: Female sex vs. Male sex. Primary outcome: all-cause mortality (adjusted HR 0.79, 95% CI 0.73 to 0.86, p=0.001).

What question did this study set out to answer?

This study aims to evaluate how sex influences outcomes after transcatheter aortic valve replacement, focusing on mortality and safety.

June 13, 2026

Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes

Key Result

Female sex was independently associated with improved survival after transcatheter aortic valve replacement (adjusted HR 0.79; 95% CI 0.73-0.86; p=0.001), despite more bleeding and vascular events.

Key Points

This study aims to evaluate how sex influences outcomes after transcatheter aortic valve replacement, focusing on mortality and safety.
Collaborative meta-analysis using data from 5 studies in MEDLINE, Embase, and Cochrane Library
Generated a patient-level database encompassing time-to-event data from selected studies
Primary outcome was all-cause mortality, with 30-day safety endpoints including major vascular complications, bleeding, and stroke
Women had higher rates of major vascular complications (6.3% vs. 3.4%; p < 0.001) and major bleeding events (10.5% vs. 8.5%; p = 0.003)
No differences in procedural 30-day mortality (2.6% vs. 2.2%; p = 0.24)
Female sex linked to improved survival at median follow-up of 387 days (adjusted HR 0.79; 95% CI 0.73-0.86; p = 0.001)

Study Design

Type

Meta-Analysis (n=11,310)

Multicenter

Yes

Structured PICO

Does female sex influence mortality and safety outcomes in patients undergoing transcatheter aortic valve replacement?

Population

11,310 patients undergoing transcatheter aortic valve replacement, followed for a median of 387 days.

Exposure

Female sex

Comparator

Male sex

Outcome

All-cause mortalityhard clinical

Female sex is an independent predictor of late survival after TAVR, despite higher early rates of bleeding, vascular, and stroke complications.

Main Result

Hazard Ratio: 0.79 (95% CI 0.73–0.86)

p-value: p=0.001

Abstract

BACKGROUND: There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement. OBJECTIVES: The aim of this study was to evaluate the impact of sex on early and late mortality and safety end points after transcatheter aortic valve replacement using a collaborative meta-analysis of patient-level data. METHODS: From the MEDLINE, Embase, and the Cochrane Library databases, data were obtained from 5 studies, and a database containing individual patient-level time-to-event data was generated from the registry of each selected study. The primary outcome of interest was all-cause mortality. The safety end point was the combined 30-day safety end points of major vascular complications, bleeding events, and stroke, as defined by the Valve Academic Research Consortium when available. RESULTS: Five studies and their ongoing registry data, comprising 11,310 patients, were included. Women constituted 48.6% of the cohort and had fewer comorbidities than men. Women had a higher rate of major vascular complications (6.3% vs. 3.4%; p < 0.001), major bleeding events (10.5% vs. 8.5%; p = 0.003), and stroke (4.4% vs. 3.6%; p = 0.029) but a lower rate of significant aortic incompetence (grade ≥2; 19.4% vs. 24.5%; p < 0.001). There were no differences in procedural and 30-day mortality between women and men (2.6 % vs. 2.2% p = 0.24 and 6.5% vs. 6.5% p = 0.93, respectively), but female sex was independently associated with improved survival at median follow-up of 387 days (interquartile range: 192 to 730 days) from the index procedure (adjusted hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p = 0.001). CONCLUSIONS: Although women experience more bleeding events, as well as vascular and stroke complications, female sex is an independent predictor of late survival after transcatheter aortic valve replacement. This should be taken into account during patient selection for this procedure.

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