Abstract
Non-vitamin K antagonist oral anticoagulants (NOACs) include thrombin inhibitor dabigatran and coagulation factor Xa inhibitors rivaroxaban, apixaban, edoxaban, and betrixaban. NOACs have several benefits over warfarin, including faster time to the achieve effect, rapid onset of action, fewer documented food and drug interactions, lack of need for routine INR monitoring, and improved patient satisfaction. Local hemostatic measures, supportive care, and withholding the next NOAC dose are usually sufficient to achieve hemostasis among patients presenting with minor bleeding. The administration of reversal agents should be considered in patients on NOAC's with major bleeding manifestations (life-threatening bleeding, or major uncontrolled bleeding), or those who require rapid anticoagulant reversal for an emergent surgical procedure. The Food and Drug Administration (FDA) has approved two reversal agents for NOACs: idarucizumab for dabigatran and andexanet alfa for apixaban and rivaroxaban. The American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS) have released an updated guideline for the management of patients with atrial fibrillation that provides indications for the use of these reversal agents. In addition, the final results of the ANNEXA-4 study that evaluated the efficacy and safety of andexanet alfa were recently published. Several agents are in different phases of clinical trials, and among them, ciraparantag has shown promising results. However, their higher cost and limited availability remains a concern. Here, we provide a brief review of the available reversal agents for NOACs (nonspecific and specific), recent updates on reversal strategies, lab parameters (including point-of-care tests), NOAC resumption, and agents in development.
Highlights
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the cornerstone in the prevention and treatment of venous thromboembolism (VTE) in nonvalvular atrial fibrillation
RE-LY trial compared Dabigatran, which is the first developed NOAC with warfarin in patients with nonvalvular atrial fibrillation. e higher 150 mg dose was associated with a lower rate of stroke and systemic embolism (SE) but a similar rate in major bleeding compared to warfarin
In the rivaroxaban and the apixaban trials, the agents were initiated without prior parenteral anticoagulation. e primary efficacy outcomes for all four NOACs were noninferior to conventional treatment—dabigatran (HR 1.09; 95% CI: 0.76 to 1.57) [6, 7], rivaroxaban (HR: 0.89; 95% CI: 0.66 to 1.19) [8], apixaban (relative risk (RR): 0.84; 95% CI: 0.60 to 1.18) [9], and edoxaban (HR: 0.89; 95% CI: 0.70 to 1.13) [6] in the referenced phase III clinical trials
Summary
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the cornerstone in the prevention and treatment of venous thromboembolism (VTE) in nonvalvular atrial fibrillation. E higher 150 mg dose was associated with a lower rate of stroke and systemic embolism (SE) but a similar rate in major bleeding compared to warfarin. A lower 110 mg dose was similar to warfarin in the prevention of stroke and SE and was associated with a lower rate of major bleeding. E ARISTOTLE trial found that apixaban was superior to warfarin in preventing stroke or SE It was associated with a lower rate of major bleeding and lower mortality [3]. For the treatment of acute VTE, six clinical trials have compared dabigatran, rivaroxaban, apixaban, and edoxaban with conventional therapy (parenteral anticoagulation followed by VKA) [5]. Apixaban was associated with a significant reduction in major bleeding compared with conventional treatment (RR: 0.31; 95% CI: 0.17 to 0.55) [9].
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