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.

Summary

In AF survivors of intracerebral hemorrhage, DOAC therapy dramatically reduced ischemic stroke (HR 0.05) but increased recurrent ICH (HR 10.89). Net clinical benefit therefore depends on individual bleeding versus ischemic risk, reinforcing the need for tailored decision-making and evaluation of alternative strategies.

Key Findings

• DOACs lowered first ischaemic stroke versus no anticoagulation (HR 0.05; p<0.0001).
• Recurrent ICH was higher with DOACs and did not meet non-inferiority margin (HR 10.89; 90% CI 1.95–60.72).
• Serious adverse events and mortality were similar in proportions between groups over median 1.4 years.

Clinical Implications

Consider DOACs for selected AF survivors of ICH with very high ischemic risk and controlled bleeding risk; systematically integrate neuroimaging markers, ICH location, and patient preference. Investigate mechanical alternatives (e.g., left atrial appendage occlusion) when bleeding risk dominates.

Limitations

• Open-label design may influence management behaviors.
• Modest sample size with wide confidence intervals for hemorrhage estimates.

Future Directions

Pool data across ongoing trials and meta-analyze to identify subgroups with net benefit; evaluate left atrial appendage occlusion and combined strategies; integrate imaging biomarkers for individualized risk models.