Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy

Abstract

AimsThe purpose of this study was to evaluate the effectiveness of a new, fixed, yet individualized dosing regimen of activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for warfarin reversal in the setting of a life-threatening bleeding in a secondary care center.MethodsIn this report we present a retrospective chart review of 72 patients who received FEIBA and 69 patients who received fresh-frozen plasma (FFP) to reverse the effects of warfarin in a setting of a life-threatening bleeding. In the FEIBA cohort, patients received 500 units of FEIBA when the initial INR was <5 or 1,000 units of FEIBA when initial INR was ≥5.ResultsFEIBA administration resulted in lower subsequent INR when compared with FFP and shorter time elapsed from drug administration to an INR ≤1.4 when compared with FFP. No significant differences in survival or in the length of hospital stay were observed. A higher FEIBA dose induced a bigger decrease in INR than the lower dose. We observed five adverse events (7%) that could potentially be related to FEIBA administration.ConclusionsThe presented dosing regimen results in safe reversal of warfarin-induced coagulopathy, which appears to be faster and more profound than following FFP. Moreover, the use of activated PCC (FEIBA) does not appear to carry an increased risk of thrombotic events when compared to the rate reported for several non-activated PCC preparations.

How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage

“…25,61 Nevertheless, despite the even greater potential risk of thrombogenicity compared with nonactivated PCCs, use of FEIBA was recommended in one publication for reversal of VKA in life-threatening bleeding if 4-factor PCCs are not available. 62 A chart review of 72 patients who received FEIBA for warfarin reversal compared with 69 patients who were treated with FFP in life-threatening bleeding indicated faster and more effective reduction of INR with FEIBA but with similar survival rates and length of hospital stay between the cohorts. Moreover, 7% of the FEIBA-treated patients experienced potentially related adverse events.…”

“…Moreover, 7% of the FEIBA-treated patients experienced potentially related adverse events. 62 Three studies used 3-factor (II, IX, X) PCC plus FFP for reversal of VKA in patients who presented with ICH and reported more rapid and effective correction with PCC. 34,40,45 Two other studies combined the use of 3-factor PCC with factor VII concentrates for emergent reversal of warfarin anticoagulation.…”

Pharmacologic interventions for reversing the effects of oral anticoagulants

“…injection plus (1) fourfactor PCC, (2) rFVIIa, or (3) aPCC will likely be effective for lowering the INR, according to the published literature. 29,[31][32][33][34][35] If surgery is needed but can be delayed for more than 24 hours, oral phytonadione alone may suffice for warfarin reversal based on the pharmacodynamics of vitamin K.…”

Developing a management plan for oral anticoagulant reversal

“…16 The frequency of treatment-related adverse events was similar with PCC and FFP, although less fluid overload was associated with PCC than with FFP. 18 The 19 No difference in survival was noted between aPCC and FFP, however. In the 72 patients receiving aPCC, 5 potentially related thromboembolic events were noted.…”