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Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study.

Authors
  • Orzel, Libby A1
  • Abel, Erik E1, 2, 3
  • Blais, Danielle M1
  • Wang, Tzu-Fei4
  • Porter, Kyle A5
  • Burcham, Pamela K1
  • 1 Department of Pharmacy, The Ohio State University Wexner Medical Center, Columbus, Ohio.
  • 2 Department of Clinical Applications, The Ohio State University Wexner Medical Center, Columbus, Ohio.
  • 3 Highmark Health, Pittsburgh, Pennsylvania.
  • 4 Division of Hematology & Oncology, The Ohio State University Wexner Medical Center, Columbus, Ohio.
  • 5 Center for Biostatistics, The Ohio State University Wexner Medical Center, Columbus, Ohio.
Type
Published Article
Journal
Pharmacotherapy
Publication Date
Dec 01, 2019
Volume
39
Issue
12
Pages
1157–1166
Identifiers
DOI: 10.1002/phar.2335
PMID: 31587337
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Bivalirudin, a direct thrombin inhibitor, is a treatment option for the management of heparin-induced thrombocytopenia (HIT) and other coagulation disorders. To date, no published studies have identified patients at risk for or the consequence of subtherapeutic bivalirudin therapy. The primary objective was to identify factors associated with failure to achieve early therapeutic anticoagulation (ETA) with bivalirudin, defined as achievement of two consecutive therapeutic activated partial thromboplastin times (aPTTs) within 24 hours. Secondary objectives included evaluating whether failure to achieve ETA was a risk factor for clinical outcomes of interest including thromboembolism, hemorrhage, and mortality. This was a retrospective cohort study. Patients between the ages of 18 and 89 years treated with bivalirudin for 24 hours or longer were identified and classified as either achieving or failing to achieve ETA. Nonadherence to the dosing protocol (odds ratio [OR] 1.7, 95% confidence interval [CI] 1.07-2.71) and creatinine clearance (CrCl) of 60 ml/min or greater (OR 2.99, 95% CI 1.12-7.97) were significantly associated with failure to achieve ETA in univariate analyses. Conversely, increasing age (OR 0.98, 95% CI 0.97-0.99) was significantly associated with achievement of ETA. Failure to achieve ETA was associated with a 4-fold increase in the odds of thromboembolism. Younger age, normal renal function, and nonadherence to the dosing protocol when targeting therapeutic anticoagulation is associated with increased risk of failure to achieve ETA. This confers an elevated risk of thromboembolism when using bivalirudin for the management of HIT or other coagulation disorders. © 2019 Pharmacotherapy Publications, Inc.

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