Efficacy and Safety of Prothrombin Complex Concentrate (PCC) for Direct Oral Anticoagulant Reversal: A Single Institutional Experience

Background An increasing number of patients (pts) requiring anticoagulation are treated with oral factor Xa inhibitors (DOAC) as an alternative to vitamin K antagonists. Prior to the recent approval of coagulation factor Xa (recombinant), inactivated-zhzo in May 2018, four factor prothrombin complex concentrates (4PCC) have been used to reverse the effects of DOACs. We retrospectively analyzed our institutional experience with 4 PCC for reversal of apixaban and rivaroxaban to determine the indications for 4PCC use and outcomes. Methods After IRB approval, pts receiving 4PCC, from Feb 2016 to January 2018 were identified from our pharmacy database and pts receiving PCC for reversal of apixiban and rivaroxaban were selected. Consenting pts medical records (MR) were reviewed for demographics and indications for DOAC and 4PCC as well as outcomes of 4PCC use. Pts were excluded if they had discontinued DOAC greater than 7 days before receiving 4PCC or if they were started on alternative forms of anticoagulation at a therapeutic dose prior to receiving PCC. Primary endpoint was clinical efficacy (clinical improvement or stability) or ability to undergo required procedure) and secondary endpoint was safety (thromboembolism and death) up to 35 days post-infusion of 4PCC. Stability for intracranial hemorrhages (ICH) was determined by clinical improvement and if head imaging performed, no change in head CT or MRI scan, whereas stability for other bleeds was determined by hemoglobin stability and opinions of providers in the MR. Primary efficacy outcome for pts undergoing surgery was based on MR comments by the performing surgeon and use of other hemostatic agents and red blood cell transfusions. Results 49 (32 male) pts, median age of 74 (31-95) years, met our study criteria and received 4PCC for reversal of apixaban (n=29) and rivaroxaban (n=20). Indications for anticoagulation were atrial fibrillation (n=35) and thrombosis (n=14). Of the 14 pts with thrombosis, 11 had deep vein thrombosis while 3 had thrombosis at other sites (arterial graft thrombus, aortic thrombus, and portal vein thrombosis). 4PCC was administered in the emergency department (n=36), intensive care unit (n=10), or the general medical wards (n=3). Indications for 4PCC included bleeding (n=40), procedure/surgery (n=6), and hemodynamic instability with clinical suspicion for bleeding (n=3). Bleeding location is reported in table 1. All procedure/surgery performed for clinical symptoms not related t