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Observational Study
. 2025 Oct;42(10):4916-4932.
doi: 10.1007/s12325-025-03287-4. Epub 2025 Jul 22.

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

Carol M Bazell  1 , Maggie N Alston  1 , Latha G Ganti  2 , Raymond C Chang  3 , H Andrew Wilsey  3 , Stephanie A Leary  1 , Winston C Fopalan  4 , Christopher W Baugh  5
Affiliations
Observational Study

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

Carol M Bazell et al. Adv Ther. 2025 Oct.

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.

Keywords: Administrative claims; Bleeding; DOAC; Demographics; Direct oral anticoagulant; Hospitalization; Medicare; Prevalence; Retrospective analysis.

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Conflict of interest statement

Declarations. Conflict of Interest: Carol Bazell, Maggie Alston, Stephanie Leary, and Winston Fopalan are employees of Milliman Inc. and received consulting fees from AstraZeneca. Latha Ganti is a consultant for AstraZeneca. Raymond Chang and H Andrew Wilsey are employees of AstraZeneca Pharmaceuticals LP and own stock in AstraZeneca. Christopher Baugh is a paid speaker for Roche Diagnostics; participated in Roche Advisory Boards; is an advisor to Lucia Health Guidelines, Quai, and Vera Health; serves on advisory boards for Pfizer, Salix Pharmaceuticals, and AstraZeneca; and has received research funding support from Abbott Laboratories, Roche Diagnostics, and Sanofi. AstraZeneca Pharmaceuticals LP produces and markets ANDEXXA (coagulation factor Xa [recombinant], inactivated-zhzo), a drug used for the reversal of anticoagulation in patients treated with apixaban and rivaroxaban. The authors report no other conflicts of interest in this work. Ethical Approval: This manuscript is based on previously collected non-identifiable healthcare administrative claims data and does not contain any new studies with human participants or animals performed by any of the authors. All uses of data in this manuscript fall under Milliman Inc.’s existing data use agreements for the data sources.

Figures

Fig. 1
Fig. 1
Cohort identification in the eligible Medicare FFS population. DOAC direct oral anticoagulant, FFS fee-for-service
Fig. 2
Fig. 2
State prevalence of DOAC use (per 1000 beneficiaries) among eligible Medicare FFS beneficiaries. DOAC direct oral anticoagulant, FFS fee-for-service
See this image and copyright information in PMC

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