Thromboembolic outcomes after use of a four-factor prothrombin complex concentrate for Vitamin K antagonist reversal in a real-world setting

Ranjit Joseph, James Burner, Sean Yates, Amanda Strickland, William Tharpe, Ravi Sarode

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

BACKGROUND A four-factor prothrombin complex concentrate (4F-PCC) was recently licensed in the United States for urgent Vitamin K antagonist (VKA) reversal based on two randomized clinical trials. These studies excluded patients at high risk of thrombosis; therefore, the risk of thrombotic complications in unselected patients remains a concern. STUDY DESIGN AND METHODS This study retrospectively evaluated the incidence of thromboembolic events (TEEs) and death in patients who received 4F-PCC for VKA reversal. The study included 113 consecutive patients who were 18 years of age and older and were administered 4F-PCC for VKA reversal. The incidence of TEE and deaths was evaluated for up to 60 days after PCC administration or until the end of hospitalization, whichever came later. RESULTS Seven (6.2%) patients developed TEEs and 17 (15%) patients died. PCC administration was probably related to TEE and subsequent death in two (1.8%) patients. Multivariate analysis revealed that a diagnosis of Factor V Leiden or antiphospholipid syndrome was predictive of TEE, and active malignancy was predictive of death. CONCLUSION This study supports the safety of 4F-PCC for urgent VKA reversal even in unselected patients. The underlying type of hypercoagulable state and the dose of PCC may influence the incidence of TEE.

Original languageEnglish (US)
Pages (from-to)799-807
Number of pages9
JournalTransfusion
Volume56
Issue number4
DOIs
StatePublished - Apr 1 2016
Externally publishedYes

Fingerprint

Vitamin K
Incidence
Antiphospholipid Syndrome
prothrombin complex concentrates
Hospitalization
Thrombosis
Multivariate Analysis
Randomized Controlled Trials
Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

Cite this

Thromboembolic outcomes after use of a four-factor prothrombin complex concentrate for Vitamin K antagonist reversal in a real-world setting. / Joseph, Ranjit; Burner, James; Yates, Sean; Strickland, Amanda; Tharpe, William; Sarode, Ravi.

In: Transfusion, Vol. 56, No. 4, 01.04.2016, p. 799-807.

Research output: Contribution to journalArticle

Joseph, Ranjit ; Burner, James ; Yates, Sean ; Strickland, Amanda ; Tharpe, William ; Sarode, Ravi. / Thromboembolic outcomes after use of a four-factor prothrombin complex concentrate for Vitamin K antagonist reversal in a real-world setting. In: Transfusion. 2016 ; Vol. 56, No. 4. pp. 799-807.
@article{5dd0bfe74770474b8b41ba46fe65f827,
title = "Thromboembolic outcomes after use of a four-factor prothrombin complex concentrate for Vitamin K antagonist reversal in a real-world setting",
abstract = "BACKGROUND A four-factor prothrombin complex concentrate (4F-PCC) was recently licensed in the United States for urgent Vitamin K antagonist (VKA) reversal based on two randomized clinical trials. These studies excluded patients at high risk of thrombosis; therefore, the risk of thrombotic complications in unselected patients remains a concern. STUDY DESIGN AND METHODS This study retrospectively evaluated the incidence of thromboembolic events (TEEs) and death in patients who received 4F-PCC for VKA reversal. The study included 113 consecutive patients who were 18 years of age and older and were administered 4F-PCC for VKA reversal. The incidence of TEE and deaths was evaluated for up to 60 days after PCC administration or until the end of hospitalization, whichever came later. RESULTS Seven (6.2{\%}) patients developed TEEs and 17 (15{\%}) patients died. PCC administration was probably related to TEE and subsequent death in two (1.8{\%}) patients. Multivariate analysis revealed that a diagnosis of Factor V Leiden or antiphospholipid syndrome was predictive of TEE, and active malignancy was predictive of death. CONCLUSION This study supports the safety of 4F-PCC for urgent VKA reversal even in unselected patients. The underlying type of hypercoagulable state and the dose of PCC may influence the incidence of TEE.",
author = "Ranjit Joseph and James Burner and Sean Yates and Amanda Strickland and William Tharpe and Ravi Sarode",
year = "2016",
month = "4",
day = "1",
doi = "10.1111/trf.13406",
language = "English (US)",
volume = "56",
pages = "799--807",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell",
number = "4",

}

TY - JOUR

T1 - Thromboembolic outcomes after use of a four-factor prothrombin complex concentrate for Vitamin K antagonist reversal in a real-world setting

AU - Joseph, Ranjit

AU - Burner, James

AU - Yates, Sean

AU - Strickland, Amanda

AU - Tharpe, William

AU - Sarode, Ravi

PY - 2016/4/1

Y1 - 2016/4/1

N2 - BACKGROUND A four-factor prothrombin complex concentrate (4F-PCC) was recently licensed in the United States for urgent Vitamin K antagonist (VKA) reversal based on two randomized clinical trials. These studies excluded patients at high risk of thrombosis; therefore, the risk of thrombotic complications in unselected patients remains a concern. STUDY DESIGN AND METHODS This study retrospectively evaluated the incidence of thromboembolic events (TEEs) and death in patients who received 4F-PCC for VKA reversal. The study included 113 consecutive patients who were 18 years of age and older and were administered 4F-PCC for VKA reversal. The incidence of TEE and deaths was evaluated for up to 60 days after PCC administration or until the end of hospitalization, whichever came later. RESULTS Seven (6.2%) patients developed TEEs and 17 (15%) patients died. PCC administration was probably related to TEE and subsequent death in two (1.8%) patients. Multivariate analysis revealed that a diagnosis of Factor V Leiden or antiphospholipid syndrome was predictive of TEE, and active malignancy was predictive of death. CONCLUSION This study supports the safety of 4F-PCC for urgent VKA reversal even in unselected patients. The underlying type of hypercoagulable state and the dose of PCC may influence the incidence of TEE.

AB - BACKGROUND A four-factor prothrombin complex concentrate (4F-PCC) was recently licensed in the United States for urgent Vitamin K antagonist (VKA) reversal based on two randomized clinical trials. These studies excluded patients at high risk of thrombosis; therefore, the risk of thrombotic complications in unselected patients remains a concern. STUDY DESIGN AND METHODS This study retrospectively evaluated the incidence of thromboembolic events (TEEs) and death in patients who received 4F-PCC for VKA reversal. The study included 113 consecutive patients who were 18 years of age and older and were administered 4F-PCC for VKA reversal. The incidence of TEE and deaths was evaluated for up to 60 days after PCC administration or until the end of hospitalization, whichever came later. RESULTS Seven (6.2%) patients developed TEEs and 17 (15%) patients died. PCC administration was probably related to TEE and subsequent death in two (1.8%) patients. Multivariate analysis revealed that a diagnosis of Factor V Leiden or antiphospholipid syndrome was predictive of TEE, and active malignancy was predictive of death. CONCLUSION This study supports the safety of 4F-PCC for urgent VKA reversal even in unselected patients. The underlying type of hypercoagulable state and the dose of PCC may influence the incidence of TEE.

UR - http://www.scopus.com/inward/record.url?scp=84947800087&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84947800087&partnerID=8YFLogxK

U2 - 10.1111/trf.13406

DO - 10.1111/trf.13406

M3 - Article

C2 - 26589481

AN - SCOPUS:84947800087

VL - 56

SP - 799

EP - 807

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 4

ER -