A UK-wide analysis of the use of reversal agents in 198 patients on direct oral anticoagulants prior to urgent procedures

IntroductionDirect oral anticoagulants (DOACs) are widely prescribed but present challenges whenpatients require urgent invasive procedures. Whilst idarucizumab is licensed for pre-procedural reversal of dabigatran, four-factor prothrombin complex concentrates (4F-PCCs)are often used off-label for oral factor Xa inhibitors. We aimed to describe real-world UK useof reversal agents prior to urgent procedures.MethodsWe conducted a UK-wide audit of adults receiving andexanet alfa, idarucizumab, or 4F-PCCto reverse apixaban, dabigatran, edoxaban, or rivaroxaban, before urgent procedures between October 2020 and June 2023. Data were collected by members of HaemSTAR, aUK-wide network led by hematology resident doctors. Primary outcomes were (1) receipt ofreversal ≤24 hours before procedure and (2) adherence to recommended dosing. Secondaryoutcomes included procedural bleeding risk, 90-day mortality, and 30-day thrombosis rate.ResultsData were collected on 198 patients, 48% undergoing high-risk procedures. Median timefrom reversal to procedure was 1.6 hours and 76% took place within 24 hours. 4F-PCC wasused in 87%, idarucizumab 8%, and andexanet alfa 5%. Tranexamic acid was administeredin 20%. 90 mortality was 24%, and thromboembolic events occurred in 3% all following 4F-PCC.ConclusionReversal agents are frequently used prior to urgent procedures in DOAC-treated patients,including for low-risk interventions. There is limited evidence to support the off-label use of4F-PCC; the risks, benefits, and cost effectiveness are uncertain. Delays to intervention, lowuse of tranexamic acid, and infrequent drug-level testing highlight opportunities to improveclinical workflows and inform future trials.