Key result
Both aPCC and 3F-PCC achieved effective haemostasis in 100% of assessable patients requiring urgent reversal of FXa-inhibitor DOACs, with an overall all-cause mortality of 7.8%.
Why the study?
Specific reversal agents for factor Xa inhibitors are unavailable in Australia, leading to off-label use of aPCC and 3F-PCC despite scarce evidence regarding their efficacy and safety.
Do aPCC and 3F-PCC provide effective haemostasis in patients on FXa-inhibitor DOACs requiring urgent reversal?
Cohort (n=51)
No
Do aPCC and 3F-PCC provide effective haemostasis in patients on FXa-inhibitor DOACs requiring urgent reversal?
Both aPCC and 3F-PCC appear to be effective off-label adjuncts for the urgent reversal of FXa-inhibitor DOACs, though the risk of thromboembolism requires careful consideration.
Supports potential off-label role for aPCC or 3F-PCC in FXa-inhibitor reversal; leaves open need for randomized trials on net benefit.
BACKGROUND: Direct acting oral anticoagulants (DOAC) are now commonly prescribed medications. Urgent reversal of their anticoagulant effect is sometimes required in emergency situations. In Australia, a specific reversal agent for factor Xa (FXa)-inhibitor DOAC is not available. Instead, two non-specific haemostatic agents, activated prothrombin complex concentrate (aPCC) and 3 factor-prothrombin complex concentrate (3F-PCC), are used off-label despite a paucity of evidence for their effectiveness or safety. AIMS: To provide further insight into the efficacy and safety of 3F-PCC and aPCC for the reversal of the anticoagulant effect of FXa inhibitor DOACs. METHODS: We conducted a single-centre retrospective cohort study to investigate the use of aPCC and 3F-PCC for patients on FXa-inhibitor DOAC who present with a significant bleeding event or who require urgent surgery. The primary outcome was haemostatic efficacy according to prespecified criteria. Safety outcomes included the thromboembolic event rate and all-cause mortality during the hospital admission. RESULTS: A total of 51 patients was included in the study (36 patients who had a spontaneous bleeding event and 15 non-bleeding patients who required urgent perioperative management). Thirty-one patients received aPCC and 20 patients received 3F-PCC. Haemostasis was adjudicated as effective in all assessable patients (n = 50; 100%). Thromboembolic events occurred in three patients who received aPCC and one patient who received 3F-PCC. All-cause mortality was 7.8% (four patients). CONCLUSIONS: Both aPCC and 3F-PCC are useful adjuncts for the management of patients who require urgent reversal of the anticoagulant effect of FXa-inhibitor DOAC. However, the risk of thromboembolism in this patient group requires careful consideration. Prospective, comparator studies are needed along with the development of guidelines that reflect the availability of haemostatic agents in Australia.
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Wallwork et al. (2021) conducted a cohort in Patients on FXa-inhibitor DOACs requiring urgent reversal (n=51). Activated prothrombin complex concentrate (aPCC) or 3 factor-prothrombin complex concentrate (3F-PCC) was evaluated on Haemostatic efficacy according to prespecified criteria. Both aPCC and 3F-PCC achieved effective haemostasis in 100% of assessable patients requiring urgent reversal of FXa-inhibitor DOACs, with an overall all-cause mortality of 7.8%.
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