Vitamin K antagonists, such as warfarin, are the most commonly prescribed anticoagulant in the United States. Supratherapeutic international normalized ratio (INR) and bleeding are common adverse events and require reversal of the vitamin K antagonist. In a randomized trial, 4-factor prothrombin complex concentrate (PCC) that contains factors II, VII, IX, and X was compared to plasma among 202 patients with major bleeding who required rapid reversal of vitamin K antagonist. The trial demonstrated that 4-factor PCC rapidly normalized the INR, increased coagulation factors, and achieved effective hemostasis either equivalent to or better than plasma. Four-factor PCC has recently been approved by the United States Food and Drug Administration (FDA), and may be used as an alternative to plasma.
1. Sarode R, Milling TJ,Jr., Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN: Efficacy andsafety of a 4-factor prothrombin complex concentrate in patients on vitamin kantagonists presenting with major bleeding: A randomized, plasma-controlled,phase iiib study. Circulation 2013;128:1234-1243.