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

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.