Outcomes Associated With Prothrombin Complex Concentrate for International Normalized Ratio Reversal in Patients on...

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.

To assess outcomes after administration of 3-factor PCC for reversal of international normalized ratio (INR).

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.

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%.

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.