![]() Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. ![]() Drug information contained herein may be time sensitive. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Last, this meta-analysis provides important data on the efficacy and safety of 4F-PCC for DOAC-reversal (especially apixaban and rivaroxaban), a strategy used by many clinicians given the limited availability and high cost associated with andexanet alpha.Every effort has been made to ensure that the information provided by Cerner Multum, Inc. An ongoing randomized trial of andexanet alpha versus usual care in patients with intracranial bleeding will provide important safety and efficacy data (NCT03661528). The high rate of thromboembolism with andexanet alpha remains a concern, but the data are dominated by one single-arm trial (ANNEXA-4). This meta-analysis confirms a few key points: 1) Patients with severe DOAC-associated bleeding are at high risk for complications (including death) even when anticoagulant reversal and hemostasis are achieved, 2) recurrent bleeding after resumption of anticoagulation remains an important concern, 3) patients who experience DOAC-associated intracranial bleeding are at particularly high risk for death, and 4) head-to-head trials of DOAC reversal agents are needed. ![]() Even with available “specific” reversal agents, cost, medication availability, and prospective randomized clinical trial data have largely been lacking to guide clinician decision making. Management of severe DOAC-associated bleeding has long been a challenge. ![]()
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