ANNEXA-I

Andexanet Alfa for Acute Intracerebral Hemorrhage in Patients Receiving a Factor Xa Inhibitor

Patient / Population Intervention / Exposition Vergleich Endpunkt

In 530 patients with factor Xa inhibitor-associated intracerebral haemorrhage, andexanet alfa improved haemostatic efficacy compared with usual care.

530

Design

Randomised open-label RCT with blinded adjudication, stopped early

Endpunkt

Haemostatic efficacy (hematoma expansion ≤35%, NIHSS increase <7, no rescue therapy 3-12 h)

Relevanz

Ergebnis67.0% vs 53.1% haemostatic efficacy (adjusted difference 13.4 points, 95% CI 4.6-22.2; P=0.003). Thromboembolic events higher (10.3% vs 5.6%), including ischaemic stroke (6.5% vs 1.5%).

Connolly SJ, et al. N Engl J Med. 2024;390(19):1745-1755. 10.1056/NEJMoa2313040

Diskussion & Kritik

Improved haemostasis came with a clear excess of thromboembolic events, and functional outcomes were not improved. Stopped early for efficacy, which tempers precision and enthusiasm for routine use over PCC.