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

doi:10.1016/s0140-6736(25)00333-2

Arrhythmias & electrophysiologyRandomised controlled trial

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

LancetPublished 26 Feb 2025

Randomised controlled trial
multicentre
open-label
phase 3
75 hospitals in six European countries
masked events adjudication committee

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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

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<0.0001

first recurrent intracerebral haemorrhage; non-inferiority not met (margin <1.735)

10.89(90% CI 1.95–60.72)

P = 0.96

Further findings

All ischaemic stroke events

DOACrate 0.83 per 100 patient-years95% CI 0.14–2.57

No anticoagulantrate 8.60 per 100 patient-years95% CI 5.43–12.80

All intracerebral haemorrhage

DOACrate 5.00 per 100 patient-years95% CI 2.68–8.39

No anticoagulantrate 0.82 per 100 patient-years95% CI 0.14–2.53

Death

DOAC10%

No anticoagulant13%

Safety

Serious adverse events · intention-to-treat

DOAC44%

No anticoagulant55%

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:10.1016/s0140-6736(25)00333-2

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Summarised from the published abstract; every number is checked against it