ACC releases guide for management of bleeding from oral anticoagulants

Abstract

In a new report on expert consensus decision pathways, the American College of Cardiology (ACC) offers up practical suggestions for managing bleeding in patients on oral anticoagulants. The report, released on August 4, includes information on the use of new reversal strategies and guidance on when to consider reinitiating therapy. Most health systems will find the guide to be a valuable resource for ensuring that processes in their organization are based on the most current information, said Daniel M. Witt, PharmD, FCCP, BCPS, clinical professor and vice chair of the department of pharmacotherapy at the University of Utah College of Pharmacy. He noted that the easy-to-follow diagrams in the decision pathway will be useful for systems trying to implement principles of anticoagulation therapy stewardship recently proposed by the Anticoagulation Forum. According to the decision pathway, the first step is for clinicians to assess the severity of bleeding in patients on oral anticoagulants and characterize it as major or nonmajor. Major bleeding is defined as meeting one or more of the following factors: bleeding in a critical site, hemodynamic instability, overt bleeding with a hemoglobin drop of 2 g/dL or more, or administration of two or more units of packed red blood cells. Patients who do not meet these criteria are considered to have a nonmajor bleeding event. Laboratory assessments such as prothrombin (PT), activated partial thromboplastin time (aPTT), or an international normalized ratio (INR) in those receiving warfarin are also helpful in determining anticoagulant activity. For major bleeding events that are life threatening or at a critical site, ACC recommends that the oral anticoagulant and any antiplatelet agents be stopped and airway and large-bore I.V. access be secured. It also recommends reversal agents. However, ACC noted that obtaining and administering reversal agents must not delay resuscitation (e.g., volume) and local hemostatic measures. Patients with nonmajor bleeding that requires hospitalization, a surgical/procedural intervention, or a transfusion should also have their oral anticoagulant stopped and managed with local and supportive care measures. The availability of reversal agents in recent years has provided clinicians more options in managing patients who experience bleeding events, especially with direct-acting oral anticoagulants (DOACs). ACC has a flow diagram within their guide that discusses considerations for reversal/hemostatic agents in those with major bleeding events based on the specific oral anticoagulant. For patients taking warfarin or other vitamin K antagonists, ACC recommends the use of vitamin K in addition to varying doses of 4F-PCC based on the patient's INR. If 4F-PCC is not available, then plasma is listed as an alternative. For those on dabigatran, 5 g of IV idarucizumab is recommended; PCC or aPCC are listed as alternatives if idarucizumab is not available. Clinicians should use andexanet alfa for patients taking apixaban and rivaroxaban; if it's not available, PCC or aPCC can be used as alternatives. Finally, for betrixaban and edoxaban, ACC recommends the use of off-label, high-dose andexanet alfa, with PCC or aPCC as alternatives. If there is a known recent ingestion within 2 to 4 hours of any of the DOACs, clinicians can consider administering activated charcoal. “A particularly useful aspect of this decision pathway is [the] consideration of resuming anticoagulation therapy once the bleeding stops,” said Witt. “Too many times the fear of recurrent bleeding leads to patients suffering paradoxical thromboembolic complications because anticoagulation therapy was not resumed in the face of an ongoing indication for thrombosis prevention. According to ACC, clinicians can restart anticoagulation if it provides a net clinical benefit after a bleeding event. The guide noted that there are several conditions for which the anticoagulant would no longer be indicated, such as a temporary indication (e.g., post-surgical prophylaxis); nonvalvular atrial fibrillation with a CHA2DS2-VASc score of less than two in men and less than three in women; or first-time provoked venous thromboembolism more than 3 months ago. However, other conditions may warrant ongoing anticoagulation, so providers should consider the net clinical benefit of oral anticoagulation, with timing of initiation based on both the thrombotic risk and rebleeding risk. The decision to restart anticoagulation should be made with input from both the patient and clinical team via “shared clinical decision making.” Patients should be educated on the risks (e.g., bleeding signs) and benefits (e.g., decreased risk of a thrombotic event) of restarting oral anticoagulation.