What is the clinical evidence from this study?

Study design: Cohort. Population: Medicare fee-for-service beneficiaries (n=16693293). Intervention: Direct oral anticoagulants (DOACs) vs. Nonusers (no evidence of anticoagulant or antiplatelet use). Primary outcome: Bleeding-related hospitalization rate per 1000 beneficiaries.

July 22, 2025Open Access

Bleeding-Related Hospitalizations Among Direct Oral Anticoagulant Users and Nonusers in Medicare Fee-For-Service: Variation in Prevalence, Burden, and Characteristics

Q: What does this research mean for the field?

Direct oral anticoagulant users in the Medicare fee-for-service population have a bleeding-related hospitalization rate four times higher than nonusers. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

Direct oral anticoagulant users had a bleeding-related hospitalization rate four times higher than nonusers (27.5 vs 6.7 per 1000 beneficiaries) in the Medicare fee-for-service population.

Study Design

Type

Cohort (n=16,693,293)

Structured PICO

Does DOAC use increase bleeding-related hospitalizations compared to nonuse in Medicare FFS beneficiaries?

Population

18.4 million Medicare fee-for-service (FFS) beneficiaries

Intervention

Direct oral anticoagulants (DOACs)

Comparator

Nonusers (no evidence of anticoagulant or antiplatelet use)

Outcome

Bleeding-related hospitalizationssafety

Among Medicare FFS beneficiaries, DOAC users had a four-fold higher rate of bleeding-related hospitalizations compared to nonusers, with gastrointestinal bleeding being the most common cause.

Main Result

Absolute Event Rate: 27.5% vs 6.7%

Limitations

Differences in coding practices may have contributed to misidentification or mischaracterization of metrics
Only analyzed Medicare FFS health insurance claims, limiting generalizability to other populations
No adjustments were made for sex, age, comorbidities, or socioeconomic status among cohorts
Did not adjust for differences in the use of specific DOACs, dosage, treatment duration, adherence, or concomitant use of other drugs
Did not identify the reason for DOAC use
Statistical testing was not performed as this was a descriptive study
Observational study, causal relationships could not be ascertained

Abstract

INTRODUCTION: Bleeding-related hospitalizations represent a major burden for patients and the US healthcare system. Anticoagulant therapies pose a greater risk for bleeding, especially among the older Medicare population. Direct oral anticoagulants (DOACs) have become the most common type of oral anticoagulant used in Medicare due to their clinical advantages. This descriptive study examines the burden of bleeding-related hospitalizations among DOAC users and nonusers (with no evidence of anticoagulant or antiplatelet use) in Medicare fee-for-service (FFS). METHODS: This was an observational retrospective cohort study of bleeding-related hospitalizations in Medicare FFS using the 2020-2022 Medicare 100% Research Identifiable Files. We used 2020-2021 pharmacy claims to classify beneficiaries into DOAC user and nonuser cohorts and 2021-2022 healthcare administrative claims to identify demographics, bleeding-related hospitalization characteristics, and outcomes. RESULTS: Of 18.4 million Medicare FFS beneficiaries who met the study's enrollment requirements, 9.3% were assigned to the DOAC user cohort, 81.5% were assigned to the nonuser cohort, and 9.1% were excluded (non-DOAC anticoagulant-only or prescription antiplatelet-only users). The bleeding-related hospitalization rate was four times higher in the DOAC user cohort compared to the nonuser cohort (27.5 and 6.7 per 1000 beneficiaries, respectively). Gastrointestinal bleeding was the most common bleed type leading to hospitalization in both DOAC user and nonuser cohorts (64.6% and 55.4%, respectively), followed by intracerebral hemorrhage (21.3% and 34.5%, respectively), and other types of bleeding (14.2% and 10.1%, respectively). Characteristics and outcomes were similar between cohorts, with variation largely related to bleeding type. CONCLUSION: This study demonstrated variations in use of DOACs and characteristics of bleeding-related hospitalizations and identified higher rates of bleeding-related hospitalizations among DOAC users compared to nonusers. Hospitalization characteristics and outcomes differed by bleeding type. These findings highlight the Medicare FFS burden of bleeding-related hospitalizations and opportunities for the improved detection and management of bleeding, particularly among DOAC users.

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