• J. Thromb. Thrombolysis · Feb 2019

    Comparative Study Observational Study

    Low-dose compared to manufacturer-recommended dose four-factor prothrombin complex concentrate for acute warfarin reversal.

    • Wesley Zemrak, Francis Manuel, Kathryn E Smith, Stephen Rolfe, Timothy Hayes, Robert L Trowbridge, Brian Carlone, and David Seder.
    • Department of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA. zemraw@mmc.org.
    • J. Thromb. Thrombolysis. 2019 Feb 1; 47 (2): 263-271.

    BackgroundFour-factor PCC is the recommended standard of care for acute warfarin reversal but optimal dosing is unknown. We aim to show that a low-dose strategy is often adequate and may reduce the risk of thromboembolic events when compared to manufacturer-recommended dosing.MethodsA weight-based dosing strategy of 15-25 units/kg was established as the institutional standard of care in May 2015. This retrospective, before-and-after cohort analysis included patients receiving 4F-PCC according to a manufacturer-recommended (n = 122) or a low-dose (n = 83) strategy. The primary efficacy outcome was a combination of INR reversal on first check and hemostatic efficacy at 24 h.ResultsDemographics, indications for warfarin, and presenting INR values were similar between the two groups. Patients in the manufacturer-recommended dose group received significantly more 4F-PCC than the low dose group (2110 units vs. 1530 units). More patients in the manufacturer-recommended dose group achieved the primary endpoint (75.4% vs. 61.4%), with more patients achieving the target INR on recheck in the manufacturer-recommended dose group (95.9% vs. 84.3%) and no difference in hemostatic efficacy between groups (79.5% vs. 74.7%). There was no difference in thromboembolic events at 72 h (4.1% vs. 1.2%) or at 30 days (8.2% vs. 4.8%). Significantly more patients in the manufacturer-recommended dose group died or were transferred to hospice care during hospitalization (21.3% vs. 9.6%).ConclusionUtilization of a low-dose 4F-PCC strategy resulted in fewer patients achieving target INR reversal, but no difference in hemostatic efficacy, thromboembolic events, or survival.

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