Cited by 219Venous Thromboembolism Diagnosis and ManagementBlood Coagulation and Thrombosis MechanismsAtrial Fibrillation Management and Outcomes

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Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use

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Martinelli, Ida, Lensing, Anthonie W. A., Middeldorp, Saskia, Levi, Marcel, Beyer-Westendorf, Jan, van Bellen, Bonno, Bounameaux, Henri, Brighton, Timothy A., Cohen, Alexander T., Trajanovic, Mila, Gebel, Martin, Lam, Phuong, Wells, Philip S., Prins, Martin H.·2016·Blood

DOI 10.1182/blood-2015-08-665927PMC PMC4832477

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Abstract

Women receiving vitamin K antagonists (VKAs) require adequate contraception because of the potential for fetal complications. It is unknown whether the use of hormonal therapy, especially those containing estrogens, is associated with recurrent venous thromboembolism (VTE) during anticoagulation. Despite the absence of data, World Health Organization guidelines state that use of estrogen-containing contraceptives confers an "unacceptable health risk" during established anticoagulation for VTE. We compared the incidences of recurrent VTE and abnormal uterine bleeding with and without concomitant hormonal therapy in women aged <60 years who were receiving anticoagulation with rivaroxaban or enoxaparin/VKA for confirmed VTE. Incidence densities in percentage per year were computed for the on and off estrogen-containing or progestin-only therapy periods. Cox regression models were fitted, with hormonal therapy (on vs off) as a time-dependent variable to derive the hazard ratio (HR) for the effects on recurrent VTE and abnormal uterine bleeding. In total, 1888 women were included. VTE incidence densities on and off hormonal therapy were 3.7%/year and 4.7%/year (adjusted HR, 0.56; 95% confidence interval [CI], 0.23-1.39), respectively, and were 3.7%/year and 3.8%/year, respectively, for estrogen-containing and progestin-only therapy. The adjusted HR for all abnormal uterine bleeding (on vs off hormonal therapy) was 1.02 (95% CI, 0.66-1.57). Abnormal uterine bleeding occurred more frequently with rivaroxaban than with enoxaparin/VKA (HR, 2.13; 95% CI, 1.57-2.89). Hormonal therapy was not associated with an increased risk of recurrent VTE in women receiving therapeutic anticoagulation. The observed increased risk of abnormal uterine bleeding with rivaroxaban needs further exploration.

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Hemorrhage and Thrombosis in Women
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Authors: Martinelli, I., Lensing, A. W. A., Middeldorp, S., Levi, M., Beyer-Westendorf, J., van Bellen, B., Bounameaux, H., Brighton, T. A., Cohen, A. T., Trajanovic, M., Gebel, M., Lam, P., Wells, P. S., & Prins, M. H.
Affiliations: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
Bayer (Germany) (DE)
Amsterdam UMC Location University of Amsterdam (NL)
University Hospital “Carl Gustav Carus,” Technische Universität Dresden, Dresden, Germany;
Department of Vascular Surgery, Beneficencia Portuguesa Hospital, São Paulo, Brazil;
University Hospital of Geneva (CH)
Prince of Wales Hospital (AU)
National Health Service (GB)
Bayer (United States) (US)
Bayer HealthCare, Ho Chi Minh, Vietnam;
University of Ottawa (CA)
Maastricht University Medical Centre (NL)
ORCID: Martinelli, Ida
Middeldorp, Saskia
Levi, Marcel
Bounameaux, Henri
Brighton, Timothy A.
Cohen, Alexander T.
Gebel, Martin
Wells, Philip S.
Venue: Blood
Publisher: American Society of Hematology
Published: 2016-03-17
Volume: 127
Issue: 11
Pages: 1417-1425
ISSN: 0006-4971 (ISSN-L)
1528-0020
DOI: 10.1182/blood-2015-08-665927
PMC: PMC4832477
OpenAlex: W2205757214
Cited by: 219
References: 50
Citations by year: 2026: 17 · 2025: 21 · 2024: 23 · 2023: 13 · 2022: 14 · 2021: 21 · 2020: 26 · 2019: 20 · 2018: 29 · 2017: 18 · 2016: 17
FWCI: 21.73
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Blood (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Archive ouverte UNIGE (University of Geneva) (publishedVersion)
Pure Amsterdam UMC (acceptedVersion, other-oa)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
Funders: Bristol-Myers Squibb
Pfizer
GlaxoSmithKline
Sanofi
Government of the United Kingdom
Bayer HealthCare
Daiichi Sankyo Europe
Topics: Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Keywords: recurrent venous thromboembolism, abnormal uterine bleeding, hormonal contraception, estrogen-containing contraceptives, progestin-only contraception, vitamin K antagonists, rivaroxaban, enoxaparin, anticoagulation, post-thrombotic syndrome
MeSH terms: Rivaroxaban, Adult, Anticoagulants, Contraceptives, Oral, Hormonal, Drug Synergism, Estrogens, Female, Humans, Middle Aged, Progestins, Recurrence, Retrospective Studies, Uterine Hemorrhage, Estrogen Replacement Therapy, Proportional Hazards Models, Randomized Controlled Trials as Topic, Enoxaparin, Venous Thromboembolism, Young Adult

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Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use

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