Four-Factor Prothrombin Complex Concentrate vs. Plasma for Rapid Vitamin K Antagonist Reversal in Patients Needing Urgent Surgical or Invasive Interventions - 4F-PCC vs. Plasma

Aug 20, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CSL Behring
Date Published:
02/26/2015
Original Posted Date:
08/20/2015
References

Description:

The goal of the trial was to evaluate four-factor prothrombin complex concentrate (4F-PCC) compared with plasma among patients receiving a vitamin K antagonist and needing an urgent surgical procedure.

Contribution to the Literature: The 4F-PCC vs. Plasma trial showed that 4F-PCC was superior to plasma at achieving effective hemostasis and rapid INR reversal.

Study Design

  • Randomized
  • Parallel

Patients receiving a vitamin K antagonist and needing an urgent surgical procedure were randomized to vitamin K and 4F-PCC (Beriplex/Kcentra/Confidex; CSL Behring, Marburg, Germany) (n = 90) versus vitamin K and plasma (n = 91).

  • Total number of enrollees: 181
  • Duration of follow-up: 45 days
  • Mean patient age: 69 years
  • Percentage female: 43%

Inclusion criteria:

  • Patients at least 18 years of age on a vitamin K antagonist and needing an urgent surgical or invasive procedure within 24 hours
  • International normalized ratio (INR) ≥2.0

Exclusion criteria:

  • Procedures in which accurate determination of blood loss was not possible
  • Coagulopathy that could be corrected solely by vitamin K administration and termination of vitamin K antagonist therapy

Principal Findings:

The primary outcome, effective hemostasis, occurred in 90% of the 4F-PCC group vs. 75% of the plasma group (p < 0.05).

The co-primary outcome, rapid INR reduction, occurred in 55% of the 4F-PCC group vs. 10% of the plasma group (p < 0.05).

The secondary outcome, adverse events, occurred in 56% of 4F-PCC group vs. 60% of plasma group.

Interpretation:

Among patients on a vitamin K antagonist needing an urgent surgical procedure, vitamin K plus 4F-PCC was superior at achieving effective hemostasis and rapid INR reversal compared with vitamin K plus plasma. This was accomplished with a similar safety profile as plasma. 4F-PCC represents an important treatment option among the sizable cohort of patients receiving a vitamin K antagonist and needing an urgent surgical procedure.

References:

Goldstein JN, Refaai MA, Milling TJ Jr, et al. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet 2015;385:2077-87.

Keywords: Anticoagulants, Blood Coagulation Disorders, Blood Coagulation Factors, Cardiac Surgical Procedures, Hemorrhage, Hemostasis, International Normalized Ratio, Plasma, Vitamin K


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