Arrhythmias & electrophysiology
Direct oral anticoagulants versus no anticoagulation for the prevention of stroke in survivors of intracerebral haemorrhage with atrial fibrillation (PRESTIGE-AF): a multicentre, open-label, randomised, phase 3 trial
Errata to this article were published (Lancet, 15 Mar 2025 ↗ · 21 Jun 2025 ↗)
Authors' conclusion
DOACs effectively prevent ischaemic strokes in survivors of intracerebral haemorrhage with atrial fibrillation but a part of this benefit is offset by a substantially increased risk of recurrent intracerebral haemorrhage.
Study context
- Population
- Adults with spontaneous intracerebral haemorrhage, AF, an indication for anticoagulation and modified Rankin Scale score ≤4
- Participants
- 319 adults
- Comparison
- DOAC vs no anticoagulation
- DOACn = 158
- No anticoagulantn = 161reference
- Primary endpoint
- Coprimary: first ischaemic stroke (superiority) and first recurrent intracerebral haemorrhage (non-inferiority, margin HR <1.735)
- Follow-up
- Median 1.4 years
Methodological detailsmulticentre, open-label, phase 3, 75 hospitals in six European countries, masked events adjudication committee
- Multicentre
- Open-label
- Phase 3
- 75 hospitals in six European countries
- Masked events adjudication committee
Primary result
As reported in the abstract
DOAC vs No anticoagulantHRP value
First ischaemic stroke
0.05(95% CI 0.01–0.36)
log-rank p<0.0001First recurrent intracerebral haemorrhage; non-inferiority not met (margin <1.735)
10.89(90% CI 1.95–60.72)
P = 0.96Further findings
All ischaemic stroke events
All intracerebral haemorrhage
Death
Safety
Serious adverse events · intention-to-treat
Original publication
Direct oral anticoagulants versus no anticoagulation for the prevention of stroke in survivors of intracerebral haemorrhage with atrial fibrillation (PRESTIGE-AF): a multicentre, open-label, randomised, phase 3 trial. Lancet. Published 26 February 2025. doi:10.
Summarised from the published abstract; every number is checked against it