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

BACKGROUND

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.

OBJECTIVES

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

METHODS

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.

RESULTS

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.

CONCLUSION

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.