Management of heavy menstrual bleeding during direct oral anticoagulant therapy for recurrent venous thromboembolism: a case report.

: A high risk of venous thromboembolism (VTE) recurrence requires extended anticoagulation but limits the options to control heavy menstrual bleeding (HMB) in women of reproductive age. We report the management of HMB in a 48-year-old woman with a history of menometrorrhagia, recurrent VTE and multiple VTE risk factors. Due to the occurrence of HMB during extended rivaroxaban treatment, the presence of a uterine fibroid and the contraindication to interrupt anticoagulation for high risk of VTE recurrence, she received hormonal treatment first with a gonadotropin-releasing hormone agonist and then with progestin. This strategy allowed to adequately control HMB, without rivaroxaban discontinuation or dose reduction, and no new thromboembolic and no more bleeding events occurred over a long follow-up period of more than 20 months. In conclusion, the use of hormonal therapy in VTE women requiring long-term anticoagulation may be an option to control HMB, without further increasing the risk of VTE recurrence.

Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies.

The pharmacokinetics of oral rivaroxaban are highly predictable and only affected to a limited extent by bodyweight; therefore, dose adjustments for bodyweight are not required. However, this raises concerns among physicians for potential under- or overdosing. This substudy of the randomised EINSTEIN DVT and EINSTEIN PE trials, which compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy, aimed to determine the incidence of major bleeding in patients with a low bodyweight and recurrent venous thromboembolism (VTE) in patients with a high bodyweight during rivaroxaban or enoxaparin/VKA therapy. More than 8,000 patients with objectively diagnosed deep-vein thrombosis or pulmonary embolism were included. Adjusted hazard ratios for recurrent VTE and bleeding were calculated using the Cox proportional hazards model. Analyses were performed for both the first 21 days of treatment and the whole treatment period. For rivaroxaban recipients, there was no association between bodyweight or body mass index (BMI) and risk of recurrent VTE (ptrend=0.87 and 0.62, respectively), major bleeding (ptrend=0.24 and 0.36, respectively) or clinically relevant bleeding (ptrend=0.17 and 0.63, respectively). Major bleeding events were numerically lower in rivaroxaban patients across all bodyweight and BMI categories. Hazard ratios for rivaroxaban vs enoxaparin/VKA were similar in all bodyweight and BMI categories, both during the first 21 days and the whole treatment period. The fixed-dose rivaroxaban regimen is not associated with an increased risk of major bleeding or recurrent VTE in patients with either a low or high bodyweight. A high BMI was not associated with an increased risk of recurrent VTE during anticoagulation.