(216) Four-Factor Prothrombin Complex Concentrate for Cardiac Surgery Bleeding or Anticoagulation Reversal

Introduction: The use of 4-factor prothrombin complex concentrate (4F-PCC) has expanded from reversal of warfarin to reversal of oral factor Xa inhibitors (OFXAi) or refractory bleeding associated with cardiac surgery. At our institution, the Antithrombotic Therapy and Hemostatic Oversight Group developed a dosing guideline for the use of 4F-PCC. The purpose of this study is two evaluate the use of 4F-PCC for all indications.

Methods: This was a retrospective cohort study of patients who received 4F-PCC between February 1 and June 30, 2022. The primary outcome was the initial dose used according to the dosing guideline. Secondary outcomes included additional doses of 4F-PCC required, successful warfarin reversal, and hemostasis achieved in treatment of bleeds of OFXAi reversal or any unexpected bleeding during or after emergent procedure if anticoagulation was reversed. Thromboembolic events and death within 30 days were other safety outcomes.

Results: In total, 112 patients were included, with a median age of 65 years (54-75). The majority of 4F-PCC use was for refractory bleeding associated with cardiac surgery (55%), followed by reversal of OFXai (27%) and warfarin reversal (6%). Flat doses of 500-1000 units were most common for cardiac surgery. Hemostasis was achieved in 44% of cardiac surgery patients with the initial dose, with 52% requiring repeat dosing. When used for emergent surgery or hemorrhage associated with OFXAi, the majority of reversal occurred ≤24 hours of last dose. In patients who received an OFXAi > 24 hours from time of reversal, 4/8 received 50U/kg rather than the recommended 25U/kg. Hemostasis was achieved in 78% of patients that received 4F-PCC for reversal of OFXAi. Use for reversal of warfarin was infrequent, but vitamin K use only occurred in 5/11 cases. There were 6 thromboembolic events in the total cohort.

Conclusions: The most common indication for 4F-PCC has shifted to management of bleeding in cardiac surgery and reversal of OFXAi. Treatment of refractory bleeding following cardiac surgery remains challenging and shifting to flat dosing may facilitate ease of dosing and cost-savings. The use of 4F-PCC for reversal of OFXAi seems effective with adequate hemostasis achieved in the majority of our cohort.