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

Abstract

Objective 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.

Intracranial Hemorrhage in Patients Receiving Factor Xa Inhibitors: Challenges and Perspectives
Ryuki Chatani
Internal Medicine15 Jul 2026Peer-reviewedCC BY-NC-NDFull textCardiovascular medicineJ-STAGE
Is the International Normalized Ratio (INR) Enough? Reevaluating INR-Based Decision-Making for Four-Factor Prothrombin Complex Concentrate in Geriatric Warfarin-Associated Intracranial Hemorrhage: A Multicenter Cohort Study
Yunus Dogan, Akkan Avci, Ramazan Guven +21
Biomedicines28 Sep 2026Peer-reviewedCC BYFull textGeneral medicineEurope PMC
Clinical Characteristics and In-Hospital Course of Symptomatic Intracranial Hemorrhage After Intravenous Alteplase in Older Adults with Acute Ischemic Stroke: A Retrospective Cohort Study
Sorina Nicoleta Munteanu, Dana Tutunaru, Aurel Nechita +7
Neurology international1 Oct 2026Peer-reviewedCC BYFull textGeneral medicineEurope PMC
Limited utility of optic nerve sheath diameter for monitoring intracranial pressure in patients with intracranial hemorrhage
Beschan Ahmad, Mario Maria Joachim Trappe, Lars-Olav Harnisch +4
Frontiers in neurology8 Oct 2026Peer-reviewedCC BYFull textNeurologyEurope PMCCrossref
Impact of insulin resistance partially mediating symptomatic intracranial hemorrhage on futile recanalization in large vessel occlusion patients
Lin Gao, Chen Gong, Zhiyuan Wang +9
Scientific Reports1 Aug 2026Peer-reviewedCC BYFull textEpidemiology & public healthDOAJ

Cite

BibTeX RIS

BibTeX

@article{wada2026characteristics,
  title = {{Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank}},
  author = {Shinichi Wada and Sohei Yoshimura and Takako Torii-Yoshimura and Junji Miyazaki and Yoshito Arakaki and Yasuhisa Yoshida and Masato Inoue and Masateru Katayama and Kenichi Morita and Yoshiki Yagita and Yoshihiro Miyamoto and Kazunori Toyoda and Masatoshi Koga},
  journal = {Internal Medicine},
  year = {2026},
  month = jul,
  doi = {10.2169/internalmedicine.6045-25},
  url = {https://www.jstage.jst.go.jp/article/internalmedicine/65/14/65_6045-25/_article},
  note = {CC BY-NC-ND},
}

RIS

TY  - JOUR
TI  - Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank
AU  - Shinichi Wada
AU  - Sohei Yoshimura
AU  - Takako Torii-Yoshimura
AU  - Junji Miyazaki
AU  - Yoshito Arakaki
AU  - Yasuhisa Yoshida
AU  - Masato Inoue
AU  - Masateru Katayama
AU  - Kenichi Morita
AU  - Yoshiki Yagita
AU  - Yoshihiro Miyamoto
AU  - Kazunori Toyoda
AU  - Masatoshi Koga
PY  - 2026
DA  - 2026/07/15
JO  - Internal Medicine
DO  - 10.2169/internalmedicine.6045-25
UR  - https://www.jstage.jst.go.jp/article/internalmedicine/65/14/65_6045-25/_article
AB  - Objective 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.
SN  - 1349-7235
SN  - 0918-2918
ER  -

Abstract

Related

Cite