Outcomes Associated With Prothrombin Complex Concentrate for International Normalized Ratio Reversal in Patients on Oral Anticoagulants With Acute Bleeding

Abstract

Background: Management of bleeding in patients on oral anticoagulants (OACs) is crucial in optimizing outcomes. No large studies examine 3-factor prothrombin complex concentrate (PCC) for OAC reversal. Objective: To assess outcomes after administration of 3-factor PCC for reversal of international normalized ratio (INR). Method: We conducted an institutional review board–approved retrospective cohort study in all patients admitted to our level II trauma center over a 5-year period from 2007 to 2012 who received PCC for INR reversal and bleeding management. The primary outcome was assessment of efficacy as measured by achievement of INR < 1.5. Secondary objectives were to evaluate: factors associated with achievement of target INR, cessation of bleeding, mortality, outcome differences with or without fresh frozen plasma (FFP) or protocol utilization, safety, and cost. Result: A total of 403 patients were evaluated. Target INR was achieved in 88.8% of patients and was influenced by baseline INR. Associated factors were younger age ( P = 0.02), utilization of the institution’s protocol ( P < 0.01), and concomitant administration of vitamin K ( P < 0.01). Concomitant FFP did not affect achievement. Bleeding cessation occurred in 333 (82.6%) patients, and 68 (16.9%) patients died. Patients who achieved target INR were more likely to have bleeding cessation ( P < 0.01). The odds of survival for those who reached target INR was 3.8 times greater ( P < 0.01). The incidence of thromboembolism was 3.7%. Conclusion: Three-factor PCC administration with IV vitamin K was effective for INR reversal and bleeding cessation and should continue to be a mainstay of therapy pending head-to-head outcome and cost comparisons with 4-factor products.