Management of Severe Bleeding in Patients Treated with Direct Oral Anticoagulants

The use of prothrombin complex concentratesand the role of plasma concentration of anticoagulantsin the management of bleedingin patients treated with direct oral anticoagulantsare still debated. Our aim was to describe management strategies and outcomes of severe bleedingevents in patients treated with direct oral anticoagulants. METHODS: We performed a prospective cohort study of 732 patients treated with dabigatran, rivaroxaban, or apixabanhospitalized for severe bleeding, included prospectively in the registry from June 2013 to November 2015. RESULTS: Bleedingwas gastrointestinal or intracranial in 37% (212 of 732) and 24% (141 of 732) of the cases, respectively. Creatinine clearance was lower than 60 ml/min in 61% (449 of 732) of the cases. The plasma concentration of direct oral anticoagulantswas determined in 62% (452 of 732) of the cases and was lower than 50 ng/ml or higher than 400 ng/ml in 9.2% (41 of 452) and in 6.6% (30 of 452) of the cases, respectively. Activated or nonactivated prothrombin complex concentrateswere administered in 38% of the cases (281 of 732). Mortality by day 30 was 14% (95% CI, 11 to 16). CONCLUSIONS: Management of severe bleedingin patients treated with direct oral anticoagulantsappears to be complex. The use of prothrombin complex concentratesdiffers depending on bleedingsites and direct oral anticoagulantplasma concentrations. Mortality differs according to bleedingsites and was similar to previous estimates.