- Question
- Is it safe to switch frail older patients with atrial fibrillation who are already on a well-controlled vitamin K antagonist (VKA) to a non-vitamin K antagonist oral anticoagulant (NOAC)?
- Design
- Pragmatic, multicenter, open-label, randomized superiority trial with 1330 patients randomized and 12 months of follow-up. Analysis was by intention to treat (662 patients in the switch-to-NOAC arm and 661 in the continue-VKA arm).
- Population
- Patients aged 75 years or older with atrial fibrillation and frailty (Groningen Frailty Indicator score ≥3) treated with INR-guided VKA. Those with a glomerular filtration rate <30 mL·min-1·1.73 m-2 or valvular atrial fibrillation were excluded.
- Intervention
- Switch from the VKA to a NOAC.
- Control
- Continuation of INR-guided VKA treatment.
- Primary outcome
- First occurrence of a major or clinically relevant nonmajor bleeding event, accounting for death as a competing risk.
- Results
- Switching to a NOAC increased the primary outcome: HR 1.69 (95% CI 1.23-2.32), with 101 events in the switch arm and 62 in the continue arm. Thromboembolic events did not differ significantly (HR 1.26; 95% CI 0.60-2.61).
- Safety
- Switching to a NOAC was associated with more major or clinically relevant nonmajor bleeding than continuing the VKA; the trial was stopped for futility after 163 primary outcome events.
- Conclusion
- In frail older patients with atrial fibrillation, switching from a VKA to a NOAC was associated with more bleeding complications without a reduction in thromboembolic events.
- Why it matters
- It challenged the routine practice of switching frail patients who are already well controlled on a VKA to a NOAC, and suggests that continuing the VKA is a reasonable option in this group.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026