A new sex-specific analysis of the DEDICATE-DZHK6 trial has provided insights into the outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis.¹ While management strategies for aortic stenosis can differ between women and men, evidence guiding these decisions has been limited. This analysis aimed to describe the sex-specific characteristics and outcomes for low- to intermediate-risk patients.

Methodology

The DEDICATE-DZHK6 trial was a randomised, controlled study that previously demonstrated the non-inferiority of TAVI compared to SAVR. This predefined descriptive subgroup analysis evaluated sex-specific effects within the trial cohort.¹ The study included 1,394 patients with severe aortic stenosis at low to intermediate surgical risk, of whom 43.3% were women. The primary endpoint was a composite of all-cause death or stroke at one year.

Results

At baseline, women in the trial were slightly older than men (mean age 74.8 vs 74.2 years, p=0.020) and presented with a higher operative risk, as indicated by a median Society of Thoracic Surgeons (STS) risk score of 2.1% versus 1.5% for men (p<0.001).¹

The primary outcome of all-cause death or stroke at one year occurred less frequently in patients assigned to TAVI in both sexes. In women, the event rate was 5.2% in the TAVI group versus 11.5% in the SAVR group (Hazard Ratio [HR] 0.46; 95% Confidence Interval [CI] 0.25–0.82). In men, the rate was 5.4% for TAVI versus 9.0% for SAVR (HR 0.61; 95% CI 0.35–1.03).¹

When analysing the components of the primary endpoint, all-cause death at one year was lower with TAVI for both women (2.6% vs 6.7%; HR 0.41; 95% CI 0.17–0.90) and men (2.6% vs 5.9%; HR 0.44; 95% CI 0.20–0.88). The incidence of stroke at one year was also lower with TAVI in women (2.6% vs 6.2%; HR 0.43; 95% CI 0.18–0.93), while the difference was less pronounced in men (3.1% vs 3.6%; HR 0.89; 95% CI 0.41–1.90).¹

Interpretation

This analysis confirms that among low- to intermediate-risk patients with severe aortic stenosis, TAVI was non-inferior to SAVR for the primary outcome in both women and men, with consistently lower event rates observed in those assigned to TAVI. According to the investigators, “Women were at particular risk for early complications irrespective of the assigned treatment and at increased stroke risk after SAVR.”¹ These findings may help to refine treatment decisions for aortic stenosis, taking sex-specific risks into account.²

References

1. Bleiziffer S, Leuschner F, Rudolph TK, et al. Sex-specific outcomes after transcatheter or surgical treatment of aortic valve stenosis: the DEDICATE-DZHK6 trial. Eur Heart J. 2026;47(11):1339-1353. https://doi.org/10.1093/eurheartj/ehaf519.

2. Valdiserri P, Mehran R. Equal tools, unequal tolls: should sex influence decision-making for aortic valve stenosis? Eur Heart J. 2026;47(11):1354-1355. https://doi.org/10.1093/eurheartj/ehaf580.

This study was funded by the German Centre for Cardiovascular Research (DZHK).

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