What is the clinical evidence from this study?

Study design: Cohort. Population: Major bleeding while receiving direct factor Xa inhibitors (n=8011). Intervention: Direct factor Xa inhibitors (FXa-I). Primary outcome: In-hospital mortality (95% CI 6.6-7.7).

What does this research mean for the field?

Among patients hospitalized for major bleeding while receiving factor Xa inhibitors, the overall in-hospital mortality rate is 7.1%, with the highest mortality observed in cases of intracranial hemorrhage. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study aims to assess the clinical characteristics and outcomes of patients with major bleeding on factor Xa inhibitors.

May 20, 2026Journal of Atherosclerosis and Thrombosis0 citationsOpen Access

Hospital Course and Outcomes After Major Bleeding in Patients on Factor Xa Inhibitors in Japan: A Nationwide Observational Study

SKShun KohsakaKeio University MYMasahiro YasakaFukuoka Hospital MHM HoshinoAstraZeneca (Brazil)

Key Result

Among patients hospitalized for major bleeding while receiving factor Xa inhibitors, the overall in-hospital mortality rate was 7.1%, with the highest mortality observed in cases of intracranial hemorrhage.

Key Points

This study aims to assess the clinical characteristics and outcomes of patients with major bleeding on factor Xa inhibitors.
Analyzed a nationwide administrative hospital claims database.
Identified 8011 patients hospitalized for major bleeding while receiving factor Xa inhibitors.
Collected data on patient demographics, bleeding sites, and in-hospital outcomes.
Overall in-hospital mortality rate was 7.1% (95% CI: 6.6–7.7%).
In-hospital mortality rates by bleeding site: 17.8% for intracranial hemorrhage, 5.1% for upper gastrointestinal bleeding.
67.9% of patients resumed oral anticoagulant therapy with a median resumption time of 3.0 days.

Study Design

Type

Cohort (n=8,011)

Multicenter

Yes

Structured PICO

Population

8,011 patients (median age 80.0 years) hospitalized with major bleeding while receiving direct factor Xa inhibitors (FXa-I) in Japan between August 2011 and May 2022.

Intervention

Direct factor Xa inhibitors (FXa-I) prior to hospitalization for major bleeding

Outcome

In-hospital mortality and resumption of oral anticoagulants (OACs)hard clinical

In a nationwide Japanese cohort, patients hospitalized with major bleeding while on factor Xa inhibitors faced a 7.1% in-hospital mortality rate, driven largely by intracranial hemorrhage.

Limitations

Selection bias cannot be excluded due to the 6-month look-back period requirement.
The database mainly includes secondary medical institutions, which may affect the applicability of results to the general population.
The database only collects monthly and yearly event timing information, potentially underestimating thromboembolic and rebleeding events.
Limited information on systolic blood pressure, laboratory data, and lifestyle-related data made it difficult to perform risk stratification for bleeding.
Exact event dates are not available, making it difficult to determine whether rebleeding occurred before or after oral anticoagulant resumption.
The database cannot link patient data from multiple institutions, which may not reflect accurate data if there is a transfer during hospitalization.

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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