Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study
Abstract Background In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a r...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-01-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/rth2.12471 |
| _version_ | 1797760795186036736 |
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| author | Eva N. Hamulyák Hanke M. G. Wiegers Luuk J. J. Scheres Barbara A. Hutten Maria E. deLange Anne Timmermans Peter E. Westerweel Marten R. Nijziel Marieke J. H. A. Kruip Marije ten Wolde Paula F. Ypma Frederikus A. Klok Laurens Nieuwenhuizen Sanne vanWissen Marcel M. C. Hovens Laura M. Faber Pieter W. Kamphuisen Harry R. Büller Saskia Middeldorp |
| author_facet | Eva N. Hamulyák Hanke M. G. Wiegers Luuk J. J. Scheres Barbara A. Hutten Maria E. deLange Anne Timmermans Peter E. Westerweel Marten R. Nijziel Marieke J. H. A. Kruip Marije ten Wolde Paula F. Ypma Frederikus A. Klok Laurens Nieuwenhuizen Sanne vanWissen Marcel M. C. Hovens Laura M. Faber Pieter W. Kamphuisen Harry R. Büller Saskia Middeldorp |
| author_sort | Eva N. Hamulyák |
| collection | DOAJ |
| description | Abstract Background In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. Rationale and Design A direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant‐associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open‐label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. Outcomes Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study. |
| first_indexed | 2024-03-12T19:03:41Z |
| format | Article |
| id | doaj.art-d2e8081b5c8c4589a7801e028e0b3c62 |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T19:03:41Z |
| publishDate | 2021-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-d2e8081b5c8c4589a7801e028e0b3c622023-08-02T06:27:11ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792021-01-015122323010.1002/rth2.12471Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA studyEva N. Hamulyák0Hanke M. G. Wiegers1Luuk J. J. Scheres2Barbara A. Hutten3Maria E. deLange4Anne Timmermans5Peter E. Westerweel6Marten R. Nijziel7Marieke J. H. A. Kruip8Marije ten Wolde9Paula F. Ypma10Frederikus A. Klok11Laurens Nieuwenhuizen12Sanne vanWissen13Marcel M. C. Hovens14Laura M. Faber15Pieter W. Kamphuisen16Harry R. Büller17Saskia Middeldorp18Department of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Gynecology and Obstetrics Amsterdam UMC University of Amsterdam Amsterdam The NetherlandsDepartment of Gynecology and Obstetrics Amsterdam UMC University of Amsterdam Amsterdam The NetherlandsDepartment of Internal Medicine Albert Schweitzer Hospital Dordrecht The NetherlandsDepartment of Hematology Catharina Hospital Eindhoven Eindhoven The NetherlandsDepartment of Hematology Erasmus University Medical Centre Rotterdam The NetherlandsDepartment of Internal Medicine Flevo Hospital Almere The NetherlandsDepartment of Hematology Haga Hospital The Hague The NetherlandsDepartment of Thrombosis and Haemostasis Leiden University Medical Centre Leiden The NetherlandsDepartment of Internal Medicine Máxima Medical Centre Veldhoven The NetherlandsDepartment of Internal Medicine OLVG Amsterdam The NetherlandsDepartment of Internal Medicine Rijnstate Hospital Arnhem The NetherlandsDepartment of Internal Medicine Red Cross Hospital Beverwijk The NetherlandsDepartment of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsDepartment of Vascular Medicine Amsterdam UMC Amsterdam Cardiovascular Sciences University of Amsterdam Amsterdam The NetherlandsAbstract Background In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. Rationale and Design A direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant‐associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open‐label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. Outcomes Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.https://doi.org/10.1002/rth2.12471dabigatranfactor Xa inhibitorsmenorrhagiaprospective studiestranexamic acid |
| spellingShingle | Eva N. Hamulyák Hanke M. G. Wiegers Luuk J. J. Scheres Barbara A. Hutten Maria E. deLange Anne Timmermans Peter E. Westerweel Marten R. Nijziel Marieke J. H. A. Kruip Marije ten Wolde Paula F. Ypma Frederikus A. Klok Laurens Nieuwenhuizen Sanne vanWissen Marcel M. C. Hovens Laura M. Faber Pieter W. Kamphuisen Harry R. Büller Saskia Middeldorp Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study Research and Practice in Thrombosis and Haemostasis dabigatran factor Xa inhibitors menorrhagia prospective studies tranexamic acid |
| title | Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study |
| title_full | Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study |
| title_fullStr | Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study |
| title_full_unstemmed | Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study |
| title_short | Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study |
| title_sort | heavy menstrual bleeding on direct factor xa inhibitors rationale and design of the medea study |
| topic | dabigatran factor Xa inhibitors menorrhagia prospective studies tranexamic acid |
| url | https://doi.org/10.1002/rth2.12471 |
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