Protocolized warfarin reversal with 4-factor prothrombin complex concentrate versus 3-factor prothrombin complex concentrate with recombinant factor VIIa

Am J Surg. 2018 May;215(5):775-779. doi: 10.1016/j.amjsurg.2017.12.011. Epub 2018 Jan 5.

Abstract

Introduction: Life-threatening bleeding can complicate warfarin therapy. Rapid anticoagulant reversal via replacement of vitamin-K dependent clotting factors is essential for hemostasis. We compare two methods of rapid factor replacement for warfarin reversal.

Methods: A retrospective cohort study of warfarin-treated patients experiencing life-threatening bleeding who received a reversal protocol comprised of 4F PCC or 3F PCC and rFVIIa was performed. Demographic, clinical and anticoagulant reversal information, and all adverse events attributed to warfarin reversal were recorded.

Results: 195 patients were included in final analysis. While baseline demographics were similar between groups, the 3F-PCC group had a longer ICU LOS and higher in-hospital mortality (p < .01, .01). Pre-reversal INR was similar between both groups, but post-reversal INR was significantly lower in the 3F-PCC group, 0.8 versus 1.3 (p < .01). Significantly more patients experienced thromboembolic complications in the 3F-PCC group than the 4F-PCC group (p < .01). Receipt of rFVIIa was significantly associated with thromboembolic complications.

Discussion: A 4F PCC reversal strategy is efficacious in INR reversal and provides lower thromboembolic risk as compared to 3F PCC with rFVIIa.

Keywords: Anticoagulation; Prothrombin complex concentrate; Recombinant factor VIIa; Reversal; Warfarin.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Anticoagulants / adverse effects*
  • Blood Coagulation Factors / adverse effects*
  • Blood Coagulation Factors / therapeutic use
  • Drug Combinations
  • Drug Therapy, Combination
  • Factor VIIa / adverse effects*
  • Female
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Hemostasis*
  • Humans
  • International Normalized Ratio
  • Male
  • Recombinant Proteins / adverse effects
  • Retrospective Studies
  • Thromboembolism / chemically induced*
  • Warfarin / administration & dosage
  • Warfarin / adverse effects*

Substances

  • Anticoagulants
  • Blood Coagulation Factors
  • Drug Combinations
  • Recombinant Proteins
  • prothrombin complex concentrates
  • Warfarin
  • recombinant FVIIa
  • Factor VIIa