FRAIL-AF
Trial question
What is the effect of switching from a VKA to a non-VKA OAC in frail elderly patients with AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 1323
1323 patients (513 female, 810 male).
Inclusion criteria: frail elderly patients with AF.
Key exclusion criteria: GFR < 30 mL/min/1.73 m²; valvular AF.
Interventions
N=662 switch to non-VKA therapy (stop the VKA and start a non-vitamin K OAC if INR is < 1.3).
N=661 continued VKA therapy (continue INR-guided VKA therapy).
Primary outcome
Occurrence of major or clinically relevant non-major bleeding complication
15.3%
9.4%
15.3 %
11.5 %
7.7 %
3.8 %
0.0 %
Switch to non-vitamin K antagonist
therapy
Continued vitamin K antagonist
therapy
Significant
increase ▲
NNH = 16
Significant increase in occurrence of major or clinically relevant non-major bleeding complication (15.3% vs. 9.4%; HR 1.69, 95% CI 1.23 to 2.32).
Secondary outcomes
No significant difference in major bleeding (3.6% vs. 2.4%; HR 1.52, 95% CI 0.81 to 2.87).
No significant difference in thromboembolic events (2.4% vs. 2%; HR 1.26, 95% CI 0.6 to 2.61).
No significant difference in all-cause mortality (6.7% vs. 7%; HR 0.96, 96% CI 0.64 to 1.45).
Conclusion
In frail elderly patients with AF, switch to non-VKA therapy was inferior to continued VKA therapy with respect to occurrence of major or clinically relevant non-major bleeding complication.
Reference
Linda P T Joosten, Sander van Doorn, Peter M van de Ven et al. Safety of Switching from a Vitamin K Antagonist to a Non-Vitamin K Antagonist Oral Anticoagulant in Frail Older Patients with Atrial Fibrillation: Results of the FRAIL-AF Randomized Controlled Trial. Circulation. 2024 Jan 23;149(4):279-289.
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