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CC BY 4.0 · Thromb Haemost
DOI: 10.1055/a-2724-4458
Stroke, Systemic, or Venous Thromboembolism

Heavy Menstrual Bleeding in Women Treated with Direct Oral Anticoagulants: Results of the Prospective HEMBLED Registry

Authors

  • Edelgard Lindhoff-Last

    1   Cardioangiology Center Bethanienhospital (CCB), Department of Coagulation Disorders, Frankfurt, Germany

  • Inka Wiegratz

    2   Fertility Center Am Palmgarten, Department of Obstetrics and Gynecology, Frankfurt, Germany

  • Olivia Ott

    1   Cardioangiology Center Bethanienhospital (CCB), Department of Coagulation Disorders, Frankfurt, Germany

  • Yvonne Weil

    3   Praxisklinik in Mittelhessen, Department of Angiology, Wetzlar, Hessen, Germany

  • Christoph Sucker

    4   Coagumed Gerinnungszentrum, Department of Haemostaseology, Berlin, Germany

  • Susan Halimeh

    5   Coagulation Center Rhein-Ruhr, Department of Haemostaseology, Duisburg, Germany

  • Holger Seidel 

    6   Center for Blood Coagulation Disorders and Transfusion (CBT), Department of Haemostaseology, Bonn and Dortmund, Germany

  • Christian Schambeck

    7   Haemostasikum, Department of Haemostaseology, München, Germany

  • Konstantin Kirchmayr

    8   Punktmed Medical Care Center, Department of Angiology and Haemostaseology, Amberg and Nürnberg, Germany

  • Eva Herrmann

    9   Institute of Biostatistics and Mathematical Modelling, Goethe University Frankfurt, Frankfurt, Germany

Funding Information This work was supported by the International ERISTA-Grant by the Bristol Myers Squibb, Pfizer Alliance (research project number: REQ-0000021564). The funder had no role in the design of the registry, in the collection, analyses, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results. Clinical Trial Registration Observational study registered at www.clinicaltrials.gov as NCT04477837.
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Graphical Abstract

Abstract

Background

Heavy menstrual bleeding (HMB) is a common complication of anticoagulant therapy in menstruating women with venous thromboembolism (VTE). Direct oral anticoagulants (DOAC) used for VTE treatment may differ in their menstrual bleeding profiles. Therefore, the prospective multicenter noninterventional investigator-initiated HEMBLED registry (heavy menstrual bleeding in patients treated with DOAC) was performed to analyze spontaneous menstrual bleeding in women treated with therapeutic DOAC doses.

Methods

A modified pictorial blood assessment chart (PBAC) score was used to define the severity of menstrual bleeding. Patients were only included when they did not use hormonal or intrauterine contraception methods. The prospective follow-up was 4 months. The primary endpoint was the comparison of the PBAC scores between the individual DOAC groups.

Results

Overall, 73 patients with 213 monthly assessments of the PBAC scores were analyzed. Patients were on average 35 years old and were anticoagulated with apixaban (62%), rivaroxaban (26%), edoxaban (7%), or dabigatran (6%). The PBAC scores of the rivaroxaban group (mean: 145 points) were significantly increased by 54% compared with the apixaban group (mean: 93 points, p = 0.0193). HMB (PBAC score > 100 points) at least once was detected in 53% of the apixaban group compared with 79% of the rivaroxaban group (p = 0.0913). The duration of menstrual bleeding was numerically shorter in the apixaban group compared with the rivaroxaban group (p = 0.1894).

Conclusion

DOAC differ in their influence on the intensity of spontaneous menstrual bleeding. This should be taken into account when advising young women with VTE who need an oral anticoagulant.

Keywords

heavy menstrual bleeding - venous thrombosis - direct oral anticoagulants - rivaroxaban - apixaban

Supplementary Material



Publication History

Received: 22 March 2025

Accepted: 19 September 2025

Article published online:
12 November 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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