ENVISAGE-TAVI AF
Trial question
Is edoxaban noninferior to VKAs in patients with AF who underwent successful TAVR for severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 1426
1426 patients (678 female, 748 male).
Inclusion criteria: adult patients with AF who underwent successful TAVR for severe aortic stenosis.
Key exclusion criteria: coexisting conditions that confer a high risk of bleeding; history or current use of OTC medications, dietary supplements, or drugs outside protocol-specified parameters.
Interventions
N=713 edoxaban (at a dose of 30-60 mg once daily based on the body weight).
N=713 VKA (target INR of 2.0-3.0).
Primary outcome
Incidence of death from any cause, MI, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding
17.3
16.5
17.3/100 py
13.0/100 py
8.7/100 py
4.3/100 py
0.0/100 py
Edoxaban
Vitamin K
antagonist
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the incidence of death from any cause, MI, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding (17.3/100 py vs. 16.5/100 py; HR 1.05, 95% CI 0.85 to 1.31).
Secondary outcomes
No significant difference in the incidence of death from any cause (7.8/100 py vs. 9.1/100 py; HR 0.86, 95% CI 0.64 to 1.15).
No significant difference in the incidence of AIS (2.1/100 py vs. 2.8/100 py; HR 0.75, 95% CI 0.43 to 1.3).
No significant difference in the incidence of MI (1.1/100 py vs. 0.7/100 py; HR 1.65, 95% CI 0.65 to 4.14).
Safety outcomes
Significant differences in major bleeding (9.7 per 100 person-years vs. 7.0 per 100 person-years; HR 1.40, 95% CI 1.03-1.91).
Conclusion
In adult patients with AF who underwent successful TAVR for severe aortic stenosis, edoxaban was noninferior to VKA with respect to the incidence of death from any cause, MI, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding.
Reference
Nicolas M Van Mieghem, Martin Unverdorben, Christian Hengstenberg et al. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Dec 2;385(23):2150-2160.
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