Comparison of Low- Versus High-Dose Four-Factor Prothrombin Complex Concentrate (4F-PCC) for Factor Xa Inhibitor-Associated Bleeding: A Retrospective Study.


Journal

Journal of intensive care medicine
ISSN: 1525-1489
Titre abrégé: J Intensive Care Med
Pays: United States
ID NLM: 8610344

Informations de publication

Date de publication:
May 2021
Historique:
pubmed: 4 4 2020
medline: 19 8 2021
entrez: 4 4 2020
Statut: ppublish

Résumé

Although andexanet alfa was recently approved as a specific reversal agent for apixaban and rivaroxaban, some providers still elect to administer 4-factor prothrombin complex concentrate (4F-PCC) instead, due to concerns surrounding efficacy, thrombotic risk, administration logistics, availability, and cost. Previous studies have described success with 4F-PCC doses ranging from 25 to 35 U/kg, with some guidelines recommending 50 U/kg. The purpose of this study was to compare hemostasis between patients receiving low- (20-34 U/kg) versus high-dose (35-50 U/kg) 4F-PCC for the urgent reversal of apixaban and rivaroxaban. We performed a retrospective cohort study at a level one trauma center and comprehensive stroke center between January 2015 and December 2018. Main exclusion criteria included patients receiving less than 20 U/kg or if postreversal imaging were unavailable. Outcomes assessed included hemostasis for critical bleeding associated with apixaban or rivaroxaban and postoperative bleeding for reversal for emergent procedures. The low-dose strategy was administered to n = 57 (57.6%) patients at a mean dose of 26.6 U/kg. The high-dose strategy was used in n = 42 (42.4%) patients at a mean dose of 47.6 U/kg. There was no difference in hemostasis by dosing strategy (75.4% vs 78.6%, Our comparison addresses a gap in the literature surrounding optimal dosing and supports a similar efficacy profile between dosing low- versus high-dose treatment.

Sections du résumé

BACKGROUND BACKGROUND
Although andexanet alfa was recently approved as a specific reversal agent for apixaban and rivaroxaban, some providers still elect to administer 4-factor prothrombin complex concentrate (4F-PCC) instead, due to concerns surrounding efficacy, thrombotic risk, administration logistics, availability, and cost. Previous studies have described success with 4F-PCC doses ranging from 25 to 35 U/kg, with some guidelines recommending 50 U/kg.
OBJECTIVES OBJECTIVE
The purpose of this study was to compare hemostasis between patients receiving low- (20-34 U/kg) versus high-dose (35-50 U/kg) 4F-PCC for the urgent reversal of apixaban and rivaroxaban.
PATIENTS/METHODS METHODS
We performed a retrospective cohort study at a level one trauma center and comprehensive stroke center between January 2015 and December 2018. Main exclusion criteria included patients receiving less than 20 U/kg or if postreversal imaging were unavailable. Outcomes assessed included hemostasis for critical bleeding associated with apixaban or rivaroxaban and postoperative bleeding for reversal for emergent procedures.
RESULTS RESULTS
The low-dose strategy was administered to n = 57 (57.6%) patients at a mean dose of 26.6 U/kg. The high-dose strategy was used in n = 42 (42.4%) patients at a mean dose of 47.6 U/kg. There was no difference in hemostasis by dosing strategy (75.4% vs 78.6%,
CONCLUSIONS CONCLUSIONS
Our comparison addresses a gap in the literature surrounding optimal dosing and supports a similar efficacy profile between dosing low- versus high-dose treatment.

Identifiants

pubmed: 32242482
doi: 10.1177/0885066620916706
doi:

Substances chimiques

Blood Coagulation Factors 0
Factor Xa Inhibitors 0
prothrombin complex concentrates 37224-63-8

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

597-603

Auteurs

H Andrew Wilsey (HA)

Department of Pharmacy Practice, 14787Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton, NY, USA.

Abby M Bailey (AM)

Department of Pharmacy, 4530University of Kentucky HealthCare, Lexington, KY, USA.
4530University of Kentucky College of Pharmacy, Lexington, KY, USA.

Aric Schadler (A)

4530University of Kentucky College of Pharmacy, Lexington, KY, USA.
Department of Pharmacy, Kentucky Children's Hospital-Pediatrics, Lexington, KY, USA.

George A Davis (GA)

Department of Pharmacy, 4530University of Kentucky HealthCare, Lexington, KY, USA.
4530University of Kentucky College of Pharmacy, Lexington, KY, USA.

Melissa Nestor (M)

Department of Pharmacy, 4530University of Kentucky HealthCare, Lexington, KY, USA.
4530University of Kentucky College of Pharmacy, Lexington, KY, USA.

Komal Pandya (K)

Department of Pharmacy, 4530University of Kentucky HealthCare, Lexington, KY, USA.
4530University of Kentucky College of Pharmacy, Lexington, KY, USA.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH