Abstract
BackgroundPatients requiring emergent warfarin reversal (EWR) have been prescribed three-factor prothrombin complex concentrate (PCC3) and four-factor prothrombin complex concentrate (PCC4) to reverse the anticoagulant effects of warfarin. There is no existing systematic review and meta-analysis of studies directly comparing PCC3 and PCC4.MethodsThe primary objective of this systematic review and meta-analysis was to determine the effectiveness of achieving study defined target INR goal after PCC3 or PCC4 administration. Secondary objectives were to determine the difference in safety endpoints, thromboembolic events (TE), and survival during the patients’ hospital stay. Random-effects meta-analysis models were used to estimate the odds ratios (OR), and heterogeneity associated with the outcomes. The Newcastle-Ottawa Scale was used to assess study quality, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed.ResultsTen full-text manuscripts and five abstracts provided data for the primary and secondary outcomes. Patients requiring EWR had more than three times the odds of reversal to goal INR when they were given PCC4 compared to PCC3 (OR = 3.61, 95% CI: 1.97–6.60, p < 0.001). There was no meaningful clinical association or statistically significant result between PCC4 and PCC3 groups in TE (OR = 1.56, 95% CI: 0.83–2.91, p = 0.17), or survival during hospital stay (OR = 1.34, 95% CI: 0.81–2.23, p = 0.25).ConclusionPCC4 is more effective than PCC3 in meeting specific predefined INR goals and has similar safety profiles in patients requiring emergent reversal of the anticoagulant effects of warfarin.
Highlights
Patients requiring emergent warfarin reversal (EWR) have been prescribed three-factor prothrombin complex concentrate (PCC3) and four-factor prothrombin complex concentrate (PCC4) to reverse the anticoagulant effects of warfarin
While all non-activated prothrombin complex concentrates (PCC) products contain factors II, IX, and X, they differ in their amount of factor VII, with three-factor PCC (PCC3) products providing low concentrations of factor VII relative to the other factors while four-factor PCC (PCC4) products contain higher concentrations of factor VII
In addition to the odds ratios (OR) estimates obtained from the Random-effects models (REM), conditional logistic mixed-effects models with exact likelihood based on generalized linear mixed-models (GLMM) with a logit link function were explored to see if the OR estimates from a theoretically appropriate analysis [42] differ from the results provided by the REM commonly used in metaanalysis
Summary
Patients requiring emergent warfarin reversal (EWR) have been prescribed three-factor prothrombin complex concentrate (PCC3) and four-factor prothrombin complex concentrate (PCC4) to reverse the anticoagulant effects of warfarin. Several activated and non-activated PCC products are available and have been administered to patients for the reversal of warfarin anticoagulation [1]. These products are lyophilized plasma-derived concentrates used intravenously after reconstitution that differ in their coagulation factor components. Heparin is a concern for patients with previous heparininduced thrombocytopenia (HIT) Other factorcontaining products, such as activated protein complex concentrate (FEIBA®) and recombinant factor VIIa (NovoSeven®) have been evaluated for their effectiveness in reversing INR in emergent warfarin reversal (EWR) [12,13,14,15]
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