Arrhythmias & electrophysiologyRandomised controlled trial
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
- Randomised controlled trial
- pragmatic
- multicentre
- open-label
- superiority
- prespecified futility analysis
Authors' conclusion
Switching international normalized ratio-guided VKA treatment to an NOAC in frail older patients with atrial fibrillation was associated with more bleeding complications compared with continuing VKA treatment, without an associated reduction in thromboembolic complications.
Study context
- Population
- Frail older patients with AF (≥75 years plus Groningen Frailty Indicator score ≥3) on VKA; GFR <30 or valvular AF excludedITT: 662 vs 661
- Participants
- 1,330 patients
- Comparison
- Switch from INR-guided VKA to NOAC vs continued VKA
- Switch to NOACn = 662
- Continue VKAn = 661reference
- Primary endpoint
- Major or clinically relevant nonmajor bleeding, whichever came first (death as competing risk)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Major or clinically relevant nonmajor bleeding
Switch
101
events
Continue
62
events
- HR, primary outcome
- 1.69 (switch to NOAC vs continued VKA; 95% CI 1.23-2.32)
Secondary outcomes
Thromboembolic events
- HR, thromboembolic events
- 1.26 (switch to NOAC vs continued VKA; 95% CI 0.60-2.61)
Original publication
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. Published 27 August 2023. doi:10.1161/circulationaha.123.066485
Summarised from the published abstract; every number is checked against it