Safer stroke prevention strategies are needed for patients with atrial fibrillation after intracranial hemorrhage
Edoxaban did not reduce stroke or systemic embolism but increased major bleeding in high-risk patients with atrial fibrillation who had had an intracranial hemorrhage, according to results presented in a Hot Line session at ESC Congress 2026.
Atrial fibrillation, a common irregular heart rhythm, often leads to ischemic stroke, which occurs when a blood clot blocks blood flow to the brain. Oral anticoagulants like edoxaban can prevent these strokes, but they increase the risk of bleeding, particularly in patients with a history of intracranial hemorrhage. The ENRICH-AF trial, led by Professor Ashkan Shoamanesh from McMaster University, aimed to determine if edoxaban was safe and effective for high-risk atrial fibrillation patients with prior intracranial hemorrhage.
The trial, conducted at 174 sites across 20 countries, involved 948 patients with a mean age of 77 years. Patients were randomly assigned to receive edoxaban or no anticoagulation. After an average of 28 months, edoxaban did not reduce the risk of stroke or systemic embolism compared to no anticoagulation. While ischemic stroke and myocardial infarction decreased with edoxaban, there was a nearly threefold increase in major bleeding events. In fact, major bleeding occurred in 11.6% of edoxaban recipients versus 5.2% of the control group.
These findings suggest that edoxaban may not be suitable for unselected patients with atrial fibrillation after intracranial hemorrhage. Instead, a personalized decision-making approach is necessary. Future trials, such as the ASPIRE trial comparing apixaban versus aspirin, and meta-analyses like COCROACH, will provide further insights into optimizing stroke prevention in this vulnerable population.
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