Suboptimal effect of a three‐factor prothrombin complex concentrate (Profilnine‐SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose
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abstract
BACKGROUND: Plasma transfusion is standard therapy for urgent warfarin reversal in the United States. “Four‐factor” prothrombin complex concentrate (PCC), available in Europe, has advantages over plasma therapy for warfarin reversal; however, only “three‐factor” PCCs (containing relatively low Factor [F]VII) are available in the United States.STUDY DESIGN AND METHODS: The efficacy of a three‐factor PCC for urgent warfarin reversal was evaluated in 40 patients presenting with supratherapeutic international normalized ratio (ST‐INR > 5.0) with bleeding (n = 29) or at high risk for bleeding (n = 11). In 13 patients, pre‐ and posttherapy vitamin K‐dependent factors were assayed. Historical controls (n = 42) treated with plasma alone were used for rate of ST‐INR correction comparison.RESULTS: Treatment with plasma alone (mean, 3.6 units) lowered the INR to less than 3.0 in 63 percent of historical controls. Low‐dose (25 U/kg) and high‐dose (50 U/kg) PCC alone lowered INR to less than 3.0 in 50 and 43 percent of patients, respectively. Additional transfusion of a small amount of plasma (mean, 2.1 units) increased the rate of achieving an INR of less than 3.0 to 89 and 88 percent for low‐ and high‐dose PCC therapy, respectively. FII, F IX, and FX increments were similar for PCC‐treated patients with or without supplemental plasma; FVII was significantly higher in the PCC plus plasma group compared to the PCC‐only group (p = 0.001).CONCLUSION: Three‐factor PCC does not satisfactorily lower ST‐INR due to low FVII content. Infusion of a small amount of plasma increases the likelihood of satisfactory INR lowering.
