Background: In Japan, Andexanet alfa was approved in May 2022. Improvement of clinical outcome in patients developed intracranial hemorrhage while taking factor-Xa inhibitor (FXai) is expected. To understand the real-world Japanese data, this study aimed to investigate the clinical outcomes of these patients prior to 2022.
Methods: Patients who developed intracerebral hemorrhage (ICH) and non-traumatic subarachnoid hemorrhage (SAH) while taking FXaiand admitted within 24 hours of their last known well time or onset between January 2016 and December 2021 were included. Data were obtained from a long-lasting nationwide hospital-based multicenter prospective registry: the Japan Stroke Data Bank. The outcomes were death in hospital and favorable outcome (modified Rankin Scale at discharge: 0-2).
Results: Eight hundreds and fifty-nine patients (rivaroxaban: n=227, apixaban: n=355, edoxaban: n=277) with intracranial hemorrhage (ICH: n=822, age 79±9, female 38.6 %, SAH: n=37, age 79±10, female 75.7 %) were investigated. The median National Institutes of Health Stroke Scale in ICH patients was 13 [interquartile range (IQR): 6-24], and Glasgow Coma Scale 11 [6-14] in SAH patients on admission. During the in-hospital periods (20 [11-37] days), any surgery was performed on 97 ICH patients (11.8 %) and 23 SAH patients (62.2 %). Whereas 167 ICH patients (20.3 %) and 14 SAH patients (37.8 %) died in hospital, 135 ICH patients (16.4 %) and 5 SAH patients (13.5 %) achieved favorable outcome.
Conclusion: This study showed the clinical outcomes before approval of Andexanet alfa. Further study of changes in outcomes after the approval is awaited.