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.

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusion: 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.