1323

Abstract

Introduction: Rivaroxaban, a factor-Xa inhibitor, has no antidote. Published data on the use of prothrombin complex concentrate (PCC) for the reversal of bleeding with rivaroxaban in human subjects is limited. The potential role of PCC was demonstrated in one in-vivo study which showed reversal of PT with a single bolus dose of four-factor PCC in six healthy volunteers who received rivaroxaban 20 mg once daily. We describe the use of three-factor PCC in the reversal of major, rivaroxaban-associated gastrointestinal (GI) bleeding in two patients. An 87 year-old female with atrial fibrillation (AF) was initiated on rivaroxaban 20 mg daily on the third day of hospitalization and developed a massive GI bleed on the seventh day of rivaroxaban therapy. Three-factor PCC 50 units/kg was administered with packed red blood cells (PRBCs) and fresh frozen plasma (FFP). Supraselective catherization and embolization was performed with no further bleeding. The second patient, a 74 year-old male with AF on rivaroxaban 20 mg daily, was admitted with massive GI bleed. Three-factor PCC 50 units/kg was administered with PRBCs and FFP. No further bleeding was noted. Postmarketing data has not clearly defined the bleeding rate associated with rivaroxaban use. The two patient cases presented are amongst the first published reports of the use of three-factor PCC in the management of rivaroxaban-associated bleeding. Clinical trials evaluating the use of PCC for rivaroxaban bleed are warranted.