What are the real-world patterns of DOAC reversal agent use prior to urgent procedures?
Reversal agents, predominantly off-label 4F-PCC, are frequently used prior to urgent procedures in DOAC-treated patients, highlighting a need for improved clinical workflows and further evidence.
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.
Murphy et al. (Fri,) studied this question.