# Prevalence of abnormal uterine bleeding and quality of life after venous thromboembolism by oral anticoagulant use: the GENB-OAC Study

## TL;DR

This study finds that oral anticoagulants increase abnormal uterine bleeding and reduce quality of life in women of reproductive age, with apixaban causing less bleeding than other anticoagulants.

## Contribution

The study compares the impact of different oral anticoagulants on abnormal uterine bleeding and quality of life in reproductive-age women.

## Key findings

- Oral anticoagulants significantly increase abnormal uterine bleeding compared to controls.
- Apixaban is associated with less abnormal uterine bleeding than rivaroxaban or vitamin K antagonists.
- Quality of life is lower in women using oral anticoagulants compared to controls.

## Abstract

Anticoagulants cause abnormal uterine bleeding (AUB) in women of reproductive age with venous thromboembolism, but the safety profiles of oral anticoagulants (OACs) in this setting are unclear.

To analyze and compare the prevalence of AUB and quality of life (QoL) in 4 groups (rivaroxaban, apixaban, vitamin K antagonists [VKAs], and controls).

The GENital Bleeding Oral AntiCoagulant (GENB-OAC) study was a national, multicenter, observational, cross-sectional study conducted in 10 French hospitals from 2018 to 2022. The primary outcome was the proportion of women with major genital bleeding and/or clinically relevant non-major genital bleeding and/or pictorial blood loss assessment chart score >100.

Overall, 445 women were included: 122 on apixaban, 123 on rivaroxaban, 81 taking VKAs, and 119 healthy controls. The primary genital bleeding endpoint was significantly higher in OAC vs control group (94.8% vs 82.4%; P < .001) and the rivaroxaban or VKA vs apixaban group (96.7% or 97.5% vs 90.1%; P = .04 and P = .047). Major genital bleeding was similar in the apixaban and rivaroxaban groups, but menstruation ≥8 days, clinically relevant non-major bleeding, and pictorial blood loss assessment chart score >100 were significantly higher in the rivaroxaban vs apixaban group. QoL was significantly lower in the OAC than in the control group but was similar in the 3 OAC groups.

AUB is frequent in women of reproductive age. OACs increase AUB and impact women’s QoL. Apixaban is associated with less AUB than rivaroxaban or VKAs with no difference in QoL. An international consensus is necessary to help clinicians detect and treat AUB in OAC users.

•Oral anticoagulants increase abnormal uterine bleeding in childbearing women.•Oral anticoagulants worsen quality of life due to abnormal uterine bleeding.•Apixaban causes less abnormal uterine bleeding than rivaroxaban or vitamin K antagonists.•A simple definition is needed to detect and manage abnormal uterine bleeding.

Oral anticoagulants increase abnormal uterine bleeding in childbearing women.

Oral anticoagulants worsen quality of life due to abnormal uterine bleeding.

Apixaban causes less abnormal uterine bleeding than rivaroxaban or vitamin K antagonists.

A simple definition is needed to detect and manage abnormal uterine bleeding.