EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation

ENRICH-AF

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 948 patients with atrial fibrillation and a previous intracranial haemorrhage, edoxaban did not reduce stroke or systemic embolism, and major haemorrhage compared with no anticoagulation.

N

948patients

Schéma

International PROBE RCT (open-label, blinded outcome adjudication), phase 3/4, 1:1, event-driven until 123 adjudicated primary efficacy events; 174 sites in 20 countries, enrolment from September 2019 with follow-up to 2026; after the 2023 DSMB review no further patients with lobar intracerebral or convexity subarachnoid haemorrhage were enrolled

Critère

Primary efficacy — stroke (ischaemic, haemorrhagic or unspecified) or systemic embolism; primary safety — ISTH major haemorrhage

Pertinence

2Important — l’un des piliers parmi d’autres.

RésultatStroke or systemic embolism 11.8% vs 12.8% (HR 0.88, 95% CI 0.61-1.26; P = 0.48) over a mean 28 months. The composite hides two opposite effects: ischaemic stroke 6.2% vs 10.3% (HR 0.57, 0.36-0.90) against haemorrhagic stroke 5.8% vs 1.9% (HR 2.99, 1.41-6.37). ISTH major bleeding 11.6% vs 5.2% (HR 2.23, 1.39-3.59; P < 0.001), fatal bleeding 4.1% vs 0.8%. Death 25.3% vs 23.7%. Recurrent intracranial haemorrhage on edoxaban ran at 7.4 per 100 patient-years after lobar ICH or convexity SAH, against 2.4 after non-lobar ICH.

Shoamanesh A, Sharma M, Hart RG, et al. Presented at ESC Congress 2026, Hot Line 2, 29 August. Not yet published.

Discussion et critique

The largest randomised trial of anticoagulation after intracranial haemorrhage, and the answer is that the two effects cancel: edoxaban cut ischaemic stroke by 43% and tripled haemorrhagic stroke, leaving the composite flat and major bleeding doubled. The trial found its own contraindication along the way — the safety board removed patients with lobar ICH or convexity subarachnoid haemorrhage in 2023 after recurrent bleeding on edoxaban reached about 11% against 1%, and the final data put that group at 7.4 recurrent haemorrhages per 100 patient-years. It closed with 116 of 123 planned events, so 78% power for the effect it was designed to detect. Read as a selection question, not a yes-or-no one: non-lobar bleeds may be anticoagulated, amyloid-pattern bleeds should not.