Author/Authors :
Refaai, Majed A University of Rochester Medical Center - Rochester - NY, USA , Kothari, Truptesh H University of Rochester Medical Center - Rochester - NY, USA , Straub, Shana University of Rochester Medical Center - Rochester - NY, USA , Falcon, Jacob Seton Dell Medical School Stroke Institute - Dell Children’s Medical Center - University Medical Center at Brackenridge - Austin - TX, USA , Sarode, Ravi University of Texas Southwestern Medical Center - Dallas - TX, USA , Goldstein, Joshua N Massachusetts General Hospital - Boston - MA, USA , Brainsky, Andres CSL Behring, King of Prussia - PA - USA , Omert, Laurel CSL Behring, King of Prussia - PA - USA , Lee, Martin L UCLA Fielding School of Public Health - Los Angeles - CA - USA , Milling, Truman J Seton Dell Medical School Stroke Institute - Dell Children’s Medical Center - University Medical Center at Brackenridge - Austin - TX, USA
Abstract :
Introduction. To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex/Kcentra]) 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.
Keywords :
Complex Concentrate Reduces , Vitamin K Antagonist , Experiencing Gastrointestinal Bleeding , Post Hoc Analysis , PCC group , VKA
