Hospital Course and Outcomes After Major Bleeding in Patients on Factor Xa Inhibitors in Japan: A Nationwide Observational Study
Abstract
AIM: To evaluate the clinical characteristics, management, and in-hospital outcomes of patients hospitalized with major bleeding while receiving direct factor Xa inhibitors (FXa-I) using a large-scale, nationwide administrative claims database. METHODS: This retrospective cohort study analyzed an administrative hospital claims database to identify patients hospitalized with major bleeding while receiving FXa-I between August 2011 and May 2022 (before the launch of andexanet alfa), resulting in 8011 patients (median age, 80.0 years) being eligible for the analysis. The data collected encompassed patient demographics, hospitalization details, bleeding sites, and outcomes of interest, such as in-hospital mortality and the resumption of OACs. RESULTS: The most common bleeding sites were upper gastrointestinal bleeding (GIB; 30.3%), intracranial hemorrhage (ICH; 17.6%), lower GIB (11.7%), and trauma-related bleeding (9.1%). Patients had a median hospital stay of 11.0 days (range, 1-911 days). The overall in-hospital mortality rate was 7.1% (95% CI: 6.6-7.7%). In-hospital mortality rates by bleeding site were 17.8% for ICH, 5.1% for upper GIB, 1.4% for lower GIB, 10.2% for trauma-related bleeding, and 4.1% for other bleeding sites. The most common cause of death was hemorrhage-related (70.1%). OACs were resumed in 67.9% of patients, with a median time to resumption of 3.0 days. CONCLUSION: In this nationwide study, the in-hospital mortality rate for patients hospitalized for FXa-I-related major bleeding was approximately 7%. Although most patients resumed oral anticoagulant therapy during hospitalization, the significant in-hospital mortality rates observed, especially in cases of ICH, highlight the need for strategies to further improve the outcomes in patients experiencing FXa-I-related complications.
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BibTeX
@article{kohsaka2026hospital,
title = {{Hospital Course and Outcomes After Major Bleeding in Patients on Factor Xa Inhibitors in Japan: A Nationwide Observational Study}},
author = {Shun Kohsaka and Masahiro Yasaka and Mitsuru Hoshino and Ryotaro Ide and Fumitaka Wada and Naru Morita},
journal = {Journal of Atherosclerosis and Thrombosis},
year = {2026},
month = sep,
doi = {10.5551/jat.65869},
url = {https://www.jstage.jst.go.jp/article/jat/33/9/33_65869/_article},
note = {CC BY-NC-SA},
}
RIS
TY - JOUR
TI - Hospital Course and Outcomes After Major Bleeding in Patients on Factor Xa Inhibitors in Japan: A Nationwide Observational Study
AU - Shun Kohsaka
AU - Masahiro Yasaka
AU - Mitsuru Hoshino
AU - Ryotaro Ide
AU - Fumitaka Wada
AU - Naru Morita
PY - 2026
DA - 2026/09/01
JO - Journal of Atherosclerosis and Thrombosis
DO - 10.5551/jat.65869
UR - https://www.jstage.jst.go.jp/article/jat/33/9/33_65869/_article
AB - AIM: To evaluate the clinical characteristics, management, and in-hospital outcomes of patients hospitalized with major bleeding while receiving direct factor Xa inhibitors (FXa-I) using a large-scale, nationwide administrative claims database. METHODS: This retrospective cohort study analyzed an administrative hospital claims database to identify patients hospitalized with major bleeding while receiving FXa-I between August 2011 and May 2022 (before the launch of andexanet alfa), resulting in 8011 patients (median age, 80.0 years) being eligible for the analysis. The data collected encompassed patient demographics, hospitalization details, bleeding sites, and outcomes of interest, such as in-hospital mortality and the resumption of OACs. RESULTS: The most common bleeding sites were upper gastrointestinal bleeding (GIB; 30.3%), intracranial hemorrhage (ICH; 17.6%), lower GIB (11.7%), and trauma-related bleeding (9.1%). Patients had a median hospital stay of 11.0 days (range, 1-911 days). The overall in-hospital mortality rate was 7.1% (95% CI: 6.6-7.7%). In-hospital mortality rates by bleeding site were 17.8% for ICH, 5.1% for upper GIB, 1.4% for lower GIB, 10.2% for trauma-related bleeding, and 4.1% for other bleeding sites. The most common cause of death was hemorrhage-related (70.1%). OACs were resumed in 67.9% of patients, with a median time to resumption of 3.0 days. CONCLUSION: In this nationwide study, the in-hospital mortality rate for patients hospitalized for FXa-I-related major bleeding was approximately 7%. Although most patients resumed oral anticoagulant therapy during hospitalization, the significant in-hospital mortality rates observed, especially in cases of ICH, highlight the need for strategies to further improve the outcomes in patients experiencing FXa-I-related complications.
SN - 1880-3873
SN - 1340-3478
ER -