Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank

Objectives Since andexanet alfa was approved in May 2022 in Japan, improvement in clinical outcomes of patients with intracranial hemorrhage while on factor Xa inhibitors (FXaIs) is expected. To assess real-world outcomes before approval, this study investigated the clinical outcomes in Japan prior to 2022. Methods Patients who developed intracerebral hemorrhage (ICH) or non-traumatic subarachnoid hemorrhage (SAH) and were admitted within 24 h of their last known well time or onset of symptoms between January 2016 and December 2021 were included. Data were obtained from the Japan Stroke Data Bank, a nationwide multicenter prospective registry. The outcomes were in-hospital mortality and favorable outcomes (modified Rankin Scale score of 0-2 at discharge). Results A total of 859 patients (rivaroxaban, n=227; apixaban, n=355; edoxaban, n=277) with ICH (ICH: n=822, age 79±9 years, 38.6% female; SAH: n=37, age 79±10, 75.7% female) were investigated. On admission, the median National Institutes of Health Stroke Scale (NIHSS) score in ICH patients was 13 [interquartile range (IQR): 6-24], and the median Glasgow Coma Scale score in patients with SAH was 11 [IQR: 6-14]. During the in-hospital period (20 [IQR: 11-37] days), 167 patients with ICH (20.3%) and 14 patients with SAH (37.8%) died in hospital; 135 patients with ICH (16.4%) and 5 patients with SAH (13.5%) achieved a favorable outcome. Conclusion This study presents the clinical outcomes prior to the approval of andexanet alfa. Further studies are needed to evaluate post-approval outcome changes.