Abnormal Vaginal Bleeding and Oral Anticoagulants for DVT – Results from the AMPLIFY trial
This study by Brekelmans et al. (Thromb Haemost, 2017) aimed to analyze the characteristics of abnormal vaginal bleeding in patients being treated for venous thromboembolism (VTE) with either apixaban or enoxaparin / warfarin.
Retrospective Cohort Study
Using data from the AMPLIFY trial, incidence of abnormal vaginal bleeding was compared between women taking apixaban and enoxaparin/warfarin in the setting of VTE. 1,122 women were treated with apixaban and 1,106 were treated with enoxaparin/warfarin. Clinically relevant non-major vaginal bleeding occurred in 2.5% apixaban and 2.1% enoxaparin/warfarin recipients (odds ratio 1.2, 95 % CI 0.7-2.0). 45% of apixaban and 20% of enoxaparin/warfarin bleeds were vaginal in origin. In premenopausal patients, bleeding tended to be more prolonged for those in the apixaban group. Overall, diagnostic tests were performed in 21% of apixaban and 29% of enoxaparin/warfarin patients. Following diagnostic tests, medical treatment was not necessary in 57% of apixaban and 67% of enoxaparin/warfarin patients. The authors concluded that while the relative occurrence of bleeding was somewhat higher in women treated with apixaban (with odds ratio 95% CI crossing ‘1’), in most patients (75%) the overall clinical presentation and course were mild and comparable between groups.
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