The use of 4F‐PCC to correct direct oral anticoagulant‐induced coagulopathy: An observational analysis

BACKGROUND: With the approval of four-factor prothrombin complex concentrate (4F-PCC, Kcentra) for the reversal of vitamin K antagonist-associated bleeding in the United States, it has become a relatively common practice for 4F-PCC to be used in an "off-label" fashion to correct coagulopathy caused by direct oral anticoagulants (DOACs). However, the efficacy and safety of 4F-PCC have not been well studied in this scenario. MATERIALS AND METHODS: We performed a retrospective observational study on the off-label use of 4F-PCC for reversing bleeding associated with DOACs in a level 1 trauma centre between November 2014 and February 2017. International normalised ratio (INR) and Hgb prior to and post 4F-PCC infusion, clinical outcome and thromboembolic events within 24 hours and 45 days of 4F-PCC administration were collected. RESULTS: We identified 24 patients on DOACs who received 4F-PCC for severe haemorrhage and emergent surgeries. Most patients showed improved haemorrhage as demonstrated by stabilised intracranial haemorrhage sizes and/or by steady Hgb levels. No thromboembolic event was identified within 24 hours of 4F-PCC administration. However, 16.7% patients (4/24) experienced thromboembolic events 2 to 45 days after receiving 4F-PCC. CONCLUSION: Our data showed that 4F-PCC was relatively efficient in correcting DOAC-induced coagulopathy. We did notice that 16.7% of patients experienced some form of thromboembolic events in the days-to-weeks after 4F-PCC administration, although the imputability of 4F-PCC in these processes (vs their underlying disease) is difficult to determine. Additional prospective studies would be warranted to further evaluate the safety of 4F-PCC for this off-label indication.