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

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

doi:10.1182/blood-2015-08-665927

Cited by 166 publications

(129 citation statements)

References 39 publications

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“…104 It is unclear whether this problem occurs with the other DOACs. 105 Young women should be warned about this potential complication, and if it occurs, switching to the lower dose of the DOAC for the first few days of the menstrual cycle is usually sufficient for its control.…”

Section: Menstrual Bleedingmentioning

confidence: 99%

Evolving Treatments for Arterial and Venous Thrombosis

Chan

Eikelboom

Weitz

2016

Circulation Research

101

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Section: Menstrual Bleedingmentioning

confidence: 99%

Evolving Treatments for Arterial and Venous Thrombosis

Chan

Eikelboom

Weitz

2016

Circulation Research

101

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“…Several recent studies have shown an increased rate of vaginal bleeding events in women of reproductive age treated with rivaroxaban compared with VKA 4, 5, 6, 17. The occurrence of abnormal vaginal bleeding varied between 20 and 32% in women receiving rivaroxaban and between 12 and 15% in VKA‐treated women 4, 8, 17, 18, 19, 20.…”

Section: Discussionmentioning

confidence: 99%

“…Although the risk of major bleeding, especially intracranial haemorrhage, is lower with DOAC than with VKA therapy,1 several studies have reported an increased incidence of abnormal vaginal bleeding events in women of reproductive age treated with rivaroxaban and apixaban, compared with warfarin 4, 5, 6, 7, 8, 9. The most frequently reported symptoms were heavy and prolonged menstrual bleeding 5, 8, 9.…”

Section: Introductionmentioning

confidence: 99%

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai‐VTE study

Scheres

Brekelmans

Ageno

et al. 2018

BJOG

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ObjectiveTo investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).Design and settingPost hoc analysis of the Hokusai‐VTE study, a multicentre, randomised, double‐blind trial comparing edoxaban with warfarin for acute symptomatic VTE.PopulationWomen below 50 years receiving edoxaban or warfarin for treatment of VTE.MethodsWe collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.Main outcome measuresOccurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.ResultsIn all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person‐years (py) (95% CI 11–19) in women receiving edoxaban and 9/100 py (95% CI 6–12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1–2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8–10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0–2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.ConclusionsAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.Tweetable abstractAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

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“…The investigators concluded that in women who are on therapeutic anticoagulation, hormonal therapy did not increase the risk of recurrent VTE. 5 …”

Section: Hormonal Management Of Hmb In Women With Bleeding Disordersmentioning

confidence: 99%

“…[2][3][4][5] It is a condition hematologists are expected to understand and, in some cases, to help manage. This paper will describe normal menstruation, define HMB, summarize the causes of HMB, describe the gynecologic and hematologic evaluation of HMB, and discuss the hormonal, surgical, and hemostatic management of HMB.…”

Section: Learning Objectivesmentioning

confidence: 99%

Heavy menstrual bleeding: work-up and management

James

2016

Hematology

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Heavy menstrual bleeding (HMB), which is the preferred term for menorrhagia, affects~90% of women with an underlying bleeding disorder and~70% of women on anticoagulation. HMB can be predicted on the basis of clots of ‡1 inch diameter, low ferritin, and "flooding" (a change of pad or tampon more frequently than hourly). The goal of the work-up is to determine whether there is a uterine/endometrial cause, a disorder of ovulation, or a disorder of coagulation. HMB manifest by flooding and/or prolonged menses, or HMB accompanied by a personal or family history of bleeding is very suggestive of a bleeding disorder and should prompt a referral to a hematologist. The evaluation will include the patient's history, pelvic examination, and/or pelvic imaging, and a laboratory assessment for anemia, ovulatory dysfunction, underlying bleeding disorder, and in the case of the patient on anticoagulation, assessment for over anticoagulation. The goal of treatment is to reduce HMB. Not only will the treatment strategy depend on whether there is ovulatory dysfunction, uterine pathology, or an abnormality of coagulation, the treatment strategy will also depend on the age of the patient and her desire for immediate or long-term fertility. Hemostatic therapy for HMB may serve as an alternative to hormonal or surgical therapy, and may even be life-saving when used to correct an abnormality of coagulation. Learning Objectives• Identify 3 clinical features that correlate with true HMB • Name the first-line therapies for HMB Heavy menstrual bleeding (HMB), which is the preferred term for menorrhagia, affects~90% of women with an underlying bleeding disorder 1 and~70% of women on anticoagulation. [2][3][4][5] It is a condition hematologists are expected to understand and, in some cases, to help manage. This paper will describe normal menstruation, define HMB, summarize the causes of HMB, describe the gynecologic and hematologic evaluation of HMB, and discuss the hormonal, surgical, and hemostatic management of HMB. Normal menstruationThe following description of normal menstruation applies to all reproductive-age women, including adolescents. If fertilization (pregnancy) does not occur, the menstrual cycle begins with the sloughing or shedding of the lining of the uterus (ie, the endometrium). Then, under the influence of estrogen from ovarian follicles, the endometrium increases in thickness due to the development of glands and blood vessels. Approximately mid-cycle (in a normal cycle), ovulation occurs. The dominant ovarian follicle undergoes a process described as luteinization, becomes a corpus luteum, and secretes progesterone. Under the influence of progesterone, the endometrial glands mature and become secretory. In the absence of fertilization, the endometrial vessels constrict and the newly developed portion of the endometrium, including the new glands and blood vessels, becomes ischemic and starts to slough, thereby beginning another cycle (Figure 1).

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

Cited by 166 publications

References 39 publications

Evolving Treatments for Arterial and Venous Thrombosis

Evolving Treatments for Arterial and Venous Thrombosis

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai‐VTE study

Heavy menstrual bleeding: work-up and management

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