Management and outcomes of vaginal bleeding and heavy menstrual bleeding in women of reproductive age on direct oral anti-factor Xa inhibitor therapy: a case series

Beyer‐Westendorf, Jan; Michalski, Franziska; Tittl, Luise; Hauswald-Dörschel, Susann; Marten, Sandra

doi:10.1016/s2352-3026(16)30111-9

Cited by 56 publications

(52 citation statements)

References 19 publications

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“…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. The data for apixaban are less clear; some studies reported a similar risk of heavy vaginal bleeding for apixaban and VKA,9, 18, 20 whereas in others, apixaban was associated with an increased risk of excess vaginal bleeding 7, 8. For edoxaban, only a few cases have been described in the literature,7, 8 and in our study, the rate of abnormal vaginal bleeds appeared to be higher with edoxaban than with VKA.…”

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%

“…The most frequently reported symptoms were heavy and prolonged menstrual bleeding 5, 8, 9. The severity of the bleeds varied widely, from mild discomfort to distinct anaemia to life‐threatening bleeding requiring immediate intervention to stop the bleeding 5, 7, 8, 9…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…As DOAC use is increasing worldwide, it's unsurprising that some women are inadvertently exposed to these agents, often whilst being managed for VTE outside of the gravid state. A retrospective report of 233 cases of pregnancy exposure to DOACs with 137 known outcomes reported seven abnormalities (5·1%) of which three (2·2%) were interpreted as embryopathy: live birth with facial dysmorphism; miscarriage in week 10 with limb abnormality; elective pregnancy termination due to a fetal cardiac defect in a woman who had to terminate a previous pregnancy due to Fallot tetralogy (Beyer‐Westendorf et al , ). It's difficult to draw any robust conclusions from this early data and a multi‐centre, international registry is underway to collect both retrospective and prospective data on women exposed to DOAC during pregnancy and will hopefully provide further insights regarding the safety of these agents in this setting (International Society on Thrombosis and Haemostasis [ISTH], ).…”

Section: Women's Health and Treatment Of Vtementioning

confidence: 99%

Venous thromboembolism and women's health

et al. 2018

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Pregnancy increases the risk of VTE by 4-to 5-fold, spanning all three trimesters and peaking during the postpartum period. VTE complicates 1-2 per 1000 pregnancies (Heit, 2005) and remains the leading direct cause of maternal death at 1Á13 per 100 000 pregnancies [95% confidence interval (CI) 0Á74-1Á65], accounting for 12Á9% of maternal deaths in the UK between (Knight et al, 2017. Risk factors and prevention of pregnancy-associated VTE have been previously reviewed in detail by Guimicheva et al (2015), and are not further discussed here.

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“…Nedavni podatci ističu povećano vaginalno i teže menstrualno krvarenje u bolesnica liječenih anti-Xa lijekovima. 38 Ipak, većina se bolesnika može liječiti konzervativno. Među reverznim lijekovima, anti-Xa andexanet snizuje aktivnost antifaktora Xa u akutno krvarećih bolesnika i osigurava učinkovitu hemostazu u 79 % slučajeva.…”

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