Four-factor prothrombin complex concentrate reduces time to procedure in vitamin K antagonist-treated patients experiencing gastrointestinal bleeding: a post hoc analysis of two randomized controlled trials
Refaai MA, Kothari TH, Straub S, Falcon J, Sarode R, Goldstein JN, Brainsky A, Omert L, Lee ML, Milling TJ
Emergency Medicine International. 2017;2017:8024356.
INTRODUCTION To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex(R)/Kcentra(R)]) versus plasma on "time to procedure" in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. METHODS A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. RESULTS Analysis included 42 patients (plasma, n = 20; 4F-PCC, n = 22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; P < 0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; P < 0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; P = 0.037). CONCLUSIONS In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.