Key result
Edoxaban vs VKA showed similar NACE risk in women (HR 1.16) and men (HR 1.08), while the increased risk of major bleeding with edoxaban was attenuated in women (HR 1.11) compared to men (HR 1.75).
Why the study?
Women are at higher risk of bleeding and stroke than men after TAVR, and it is unclear whether the effect of edoxaban on these complications varies by sex.
Does edoxaban compared to vitamin K antagonist have a different effect on NACE and major bleeding in women versus men with atrial fibrillation after TAVR?
RCT (n=1,377)
Does edoxaban compared to vitamin K antagonist have a different effect on NACE and major bleeding in women versus men with atrial fibrillation after TAVR?
Hazard Ratio: 1.16 (95% CI 0.81–1.65)
p-value: p=0.820 for interaction
In patients with atrial fibrillation after TAVR, the increased risk of major bleeding associated with edoxaban compared to VKA is attenuated in women compared to men, with no sex differences in net adverse cardiovascular events.
Observational data suggest attenuated bleeding risk with edoxaban in women post-TAVR; leaves open confirmation of sex-specific effects in randomized trials.
In the ENVISAGE-TAVI AF (Edoxaban vs Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation–Atrial Fibrillation) trial, edoxaban was noninferior to vitamin K antagonists (VKA) for a composite outcome of ischemic and bleeding complications but increased major bleeding in patients with atrial fibrillation after successful transcatheter aortic valve replacement. Women are at higher risk of bleeding and stroke than men after transcatheter aortic valve replacement. It is unclear whether the effect of edoxaban on these complications varies in relation to sex. This study was to assess the effect of edoxaban vs VKA according to sex in the ENVISAGE-TAVI AF trial. The primary outcomes were net adverse cardiovascular events (NACE) and major bleeding, assessed considering the effective time on study medication (safety analysis). Out of 1,377 patients, 658 (47.8%) were women. Risks for ischemic and major bleeding outcomes were similar between women and men. Edoxaban compared to VKA was associated with a similar risk of NACE in women (HR: 1.16; 95% CI: 0.81-1.65) and men (HR: 1.08; 95% CI: 0.76-1.53; P for interaction = 0.820) and a higher risk of major bleeding in both sexes (P for interaction = 0.170). The risk increase of major bleeding was attenuated in women (HR: 1.11; 95% CI: 0.69-1.79) as compared to men (HR: 1.75; 95% CI: 1.07-2.85). There were no treatment-related differences for ischemic complications in both sexes. Edoxaban compared to VKA was associated with a similar risk of NACE and higher risk of major bleeding in both sexes. The increase in bleeding complications with edoxaban was attenuated in women.
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Mehran et al. (2023) conducted an RCT in Atrial fibrillation after transcatheter aortic valve replacement (n=1,377). Edoxaban vs. Vitamin K antagonist (VKA) was evaluated on Net adverse cardiovascular events (NACE) in women (HR 1.16, 95% CI 0.81-1.65, p=0.820 for interaction). Edoxaban vs VKA showed similar NACE risk in women (HR 1.16) and men (HR 1.08), while the increased risk of major bleeding with edoxaban was attenuated in women (HR 1.11) compared to men (HR 1.75).
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