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.
Highlights
To investigate the impact of a 4-factor prothrombin complex concentrate (4F-prothrombin complex concentrates (PCCs) [Beriplex5/Kcentra5]) versus plasma on “time to procedure” in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure
The intention-to-treat (ITT) efficacy population of the acute bleeding study and the urgent surgery/procedure study comprised 202 and 168 patients, respectively; the same number of patients (n = 185) received 4F-PCC as received plasma [16, 17]. This post hoc analysis included a total of 42 patients from the two study sites who experienced GI bleeding events; of these, 22 (52%) patients received 4F-PCC and 20 (48%) received plasma
We found that time between start of infusion and start of procedure was significantly shorter in patients who received 4F-PCC compared with those in the plasma group
Summary
To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex5/Kcentra5]) versus plasma on “time to procedure” in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. 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. Gastrointestinal (GI) bleeding is the most common major bleeding complication of VKA therapy [5, 6]; in the recent results published from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), GI bleeds represented 38% of major bleeding events in patients receiving warfarin [7]. GI bleeding is three times more common in patients with an international normalized ratio (INR)
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