897: FIXED VS VARIABLE-DOSE PROTHROMBIN COMPLEX CONCENTRATE IN WARFARIN-RELATED BLEEDING: A META-ANALYSIS

Abstract A targeted antidote for reversal of direct factor Xa (FXa) inhibitors is now available for clinical use in the United States, but it is costly and has limited availability. In a systematic review, we evaluated the safety and effectiveness of 4-factor prothrombin complex concentrate (4F-PCC) as an alternative for managing direct FXa inhibitor–related major bleeding. A systematic literature search was conducted using Medline, Embase, and the Cochrane Register of Controlled Trials up to September 2018. No comparative studies were found. Ten case series with 340 patients who received PCC for direct FXa inhibitor–related major bleeding were included. The pooled proportion of patients with effective management of major bleeding was 0.69 (95% confidence interval [CI], 0.61-0.76) in 2 studies using the International Society on Thrombosis and Haemostasis (ISTH) criteria and 0.77 (95% CI, 0.63-0.92) in 8 studies that did not use the ISTH criteria; all-cause mortality was 0.16 (95% CI, 0.07-0.26), and thromboembolism rate was 0.04 (95% CI, 0.01-0.08). On the basis of evidence with very low certainty from single-arm case series, it is difficult to determine whether 4F-PCC in addition to cessation of direct oral FXa inhibitor is more effective than cessation of direct oral FXa inhibitor alone in patients with direct FXa inhibitor–related major bleeding.

Download Full-text

920: FIXED- VERSUS VARIABLE-DOSE PROTHROMBIN COMPLEX CONCENTRATE FOR WARFARIN-ASSOCIATED MAJOR HEMORRHAGE

Critical Care Medicine ◽

10.1097/01.ccm.0000528927.97468.71 ◽

2018 ◽

Vol 46 (1) ◽

pp. 443-443

Author(s):

Gary Peksa ◽

Robert Mokszycki ◽

Megan Rech ◽

Brian Maynard ◽

Nicholas Panos ◽

...

Keyword(s):

Prothrombin Complex Concentrate ◽

Major Hemorrhage ◽

Variable Dose

Download Full-text

Comparison of 3-Factor Versus 4-Factor Prothrombin Complex Concentrate For Emergent Warfarin Reversal: A Systematic Review And Meta-Analysis

10.21203/rs.3.rs-547756/v2 ◽

2021 ◽

Author(s):

David Margraf ◽

Sarah J Brown ◽

Heather L Blue ◽

Tamara L Bezdicek ◽

Julian Wolfson ◽

...

Keyword(s):

Systematic Review ◽

Hospital Stay ◽

Prothrombin Complex Concentrate ◽

Meta Analysis ◽

Primary Objective ◽

Newcastle Ottawa Scale ◽

The Difference ◽

Warfarin Reversal ◽

Meta Analyses ◽

Analysis Models

Abstract Background: 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. There is no existing systematic review and meta-analysis of studies directly comparing PCC3 and PCC4. Methods: The 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. Results: Ten full-text manuscripts and 5 abstracts provided data for the primary and secondary outcomes. Patients requiring emergent warfarin reversal 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). Conclusion: PCC4 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.

Download Full-text