Heavy Menstrual Bleeding in Women Treated with Direct Oral Anticoagulants: Results of the Prospective HEMBLED Registry.
Edelgard Lindhoff-Last, Inka Wiegratz, Olivia Ott et al.
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In 30 seconds
The prospective, multicentre, noninterventional HEMBLED registry compared spontaneous menstrual bleeding among women with venous thromboembolism receiving therapeutic doses of direct oral anticoagulants, without hormonal or intrauterine contraception. Over 4 months, 73 women contributed 213 monthly assessments using a modified pictorial blood assessment chart. Mean scores were higher with rivaroxaban than apixaban: 145 versus 93 points, a 54% increase (p = 0.0193). Heavy menstrual bleeding occurred at least once in 79% of the rivaroxaban group and 53% of the apixaban group, a difference that was not statistically significant (p = 0.0913).
Key findings
- Mean PBAC scores were 145 points with rivaroxaban and 93 points with apixaban, a significant 54% increase with rivaroxaban (p = 0.0193).
- At least one episode of heavy menstrual bleeding occurred in 79% of the rivaroxaban group versus 53% of the apixaban group (p = 0.0913).
- Menstrual bleeding duration was numerically shorter with apixaban than rivaroxaban, but the difference was not statistically significant (p = 0.1894).
Why it matters
Menstrual bleeding burden can differ between oral anticoagulants used for venous thromboembolism. These findings highlight a patient-relevant outcome that may be relevant when discussing anticoagulant options with menstruating women, while the nonsignificant difference in the proportion experiencing heavy bleeding warrants cautious interpretation.
What to keep in mind
The registry was noninterventional, included 73 patients, and followed participants for 4 months; comparisons therefore do not establish that the anticoagulant caused the observed differences.