Four-Factor Prothrombin Complex Concentrate vs Plasma in Patients on Vitamin K Antagonists With Gastrointestinal Bleeding or Needing a Gastrointestinal Procedure: A Retrospective Analysis of 2 Randomized Controlled Trials

TL;DR

This study compares 4F-PCC and plasma for reversing blood thinners in patients with GI bleeding or needing GI procedures, finding faster clotting factor restoration with 4F-PCC.

Contribution

The study provides new evidence on the rapid INR reduction and coagulation factor restoration efficacy of 4F-PCC compared to plasma in GI-related scenarios.

Findings

4F-PCC achieved an INR of ≤1.3 in 68.2% of patients within 0.5 hours, compared to 0% with plasma.

Time to INR restoration was significantly shorter with 4F-PCC (45 minutes) than plasma (1326 minutes).

VKDF levels were significantly higher in the 4F-PCC group within 3 hours of infusion.

Abstract

To examine the efficacy of 4-factor prothrombin complex concentrate (4F-PCC) compared with plasma in vitamin K antagonist (VKA)–treated patients with gastrointestinal (GI) bleeding or requiring a GI surgical/invasive procedure.

A retrospective analysis was conducted on a subset of data from 2 prospective phase 3b randomized controlled trials of 4F-PCC or plasma for VKA reversal. Data from patients receiving VKA who experienced acute major GI bleeding or needed a GI surgical/invasive procedure within 24 hours were included in the analysis. Hemostatic efficacy, international normalized ratio (INR), and vitamin K–dependent coagulation factor (VKDF) restoration were analyzed.

In total, 171 patients were included in the analysis. Overall, hemostatic efficacy was rated excellent and good in 68 of 83 (81.9%) and 66 of 88 (75.0%) patients in the 4F-PCC and plasma treatment groups, respectively (odds ratio [OR], 1.52; 95% CI, 0.72-3.20). At 0.5 hours after infusion, 68.2% of patients treated with 4F-PCC achieved an INR of ≤1.3 compared with 0.0% of patients treated with plasma (68% difference; 95% CI, 57-79). Time to INR restoration from the start of infusion was significantly shorter for 4F-PCC than plasma (45 vs 1326 minutes, respectively; OR, 0.10; 95% CI, 0.07-0.14). All VKDF levels were significantly higher in the 4F-PCC group vs the plasma group within 3 hours from the start of infusion (all P < .002). Additional blood product use in the acute major bleeding study was comparable between both groups.

4F-PCC was associated with a nearly immediate decrease in INR and rapid VKDF restoration compared with plasma in patients experiencing acute major GI bleeding or in need of GI surgery/invasive procedure. Yet, hemostatic efficacy was similar between the 2 groups, and therefore, larger studies might be needed to better understand patient outcomes.

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