Direct oral anticoagulants (DOACs), direct inhibitors of thrombin or factor Xa (FXa), are increasingly used in clinical practice for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (NVAF) and for therapy of venous thromboembolism (VTE). Like any anticoagulant treatment, their use is associated with the risk of bleeding events. The first aim of this article is to review the data on bleeding complications from the phase III clinical studies on chronic use of DOACs and from the few available phase IV registers in use of these drugs. In all randomized studies the DOACs showed a statistical non-inferiority for safety versus comparators (in most cases warfarin), although the rates of major bleeding were significantly lower for some DOACs and treatment doses than for warfarin. Data from available phase IV registers confirm that the use of DOACs in clinical practice is not associated with higher bleeding rates versus warfarin. Secondly, we will try to propose a possible treatment of bleeding complications associated with DOACs. Given the absence of specific antidotes, strategies for proper treatment of bleeding events are crucial; however, due to the lack of data, only proposals rather than recommendations are possible.
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