Low-dose compared to manufacturer-recommended dose four-factor prothrombin complex concentrate for acute warfarin reversal.

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  • Additional Information
    • Source:
      Publisher: Kluwer Academic Publishers Country of Publication: Netherlands NLM ID: 9502018 Publication Model: Print Cited Medium: Internet ISSN: 1573-742X (Electronic) Linking ISSN: 09295305 NLM ISO Abbreviation: J Thromb Thrombolysis Subsets: MEDLINE
    • Publication Information:
      Original Publication: [Dordrecht ; Norwell, MA] : Kluwer Academic Publishers, c1994-
    • Subject Terms:
      Anticoagulants*/administration & dosage ; Anticoagulants*/adverse effects; Blood Coagulation Factors/*administration & dosage ; Hemorrhage/*drug therapy ; Hemostasis/*drug effects ; Heparin Antagonists/*administration & dosage ; Warfarin/*antagonists & inhibitors; Aged ; Aged, 80 and over ; Blood Coagulation Factors/adverse effects ; Body Weight ; Drug Dosage Calculations ; Drug Monitoring/methods ; Female ; Hemorrhage/chemically induced ; Hemorrhage/diagnosis ; Heparin Antagonists/adverse effects ; Humans ; International Normalized Ratio ; Male ; Models, Biological ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Treatment Outcome ; Warfarin/administration & dosage ; Warfarin/adverse effects
    • Abstract:
      Background: Four-factor PCC is the recommended standard of care for acute warfarin reversal but optimal dosing is unknown. We aim to show that a low-dose strategy is often adequate and may reduce the risk of thromboembolic events when compared to manufacturer-recommended dosing.
      Methods: A weight-based dosing strategy of 15-25 units/kg was established as the institutional standard of care in May 2015. This retrospective, before-and-after cohort analysis included patients receiving 4F-PCC according to a manufacturer-recommended (n = 122) or a low-dose (n = 83) strategy. The primary efficacy outcome was a combination of INR reversal on first check and hemostatic efficacy at 24 h.
      Results: Demographics, indications for warfarin, and presenting INR values were similar between the two groups. Patients in the manufacturer-recommended dose group received significantly more 4F-PCC than the low dose group (2110 units vs. 1530 units). More patients in the manufacturer-recommended dose group achieved the primary endpoint (75.4% vs. 61.4%), with more patients achieving the target INR on recheck in the manufacturer-recommended dose group (95.9% vs. 84.3%) and no difference in hemostatic efficacy between groups (79.5% vs. 74.7%). There was no difference in thromboembolic events at 72 h (4.1% vs. 1.2%) or at 30 days (8.2% vs. 4.8%). Significantly more patients in the manufacturer-recommended dose group died or were transferred to hospice care during hospitalization (21.3% vs. 9.6%).
      Conclusion: Utilization of a low-dose 4F-PCC strategy resulted in fewer patients achieving target INR reversal, but no difference in hemostatic efficacy, thromboembolic events, or survival.
    • References:
      Thromb Res. 2005;115(6):455-9. (PMID: 15792675)
      Thromb Res. 2006;118(3):313-20. (PMID: 16182346)
      Hematology. 2007 Oct;12(5):439-40. (PMID: 17852462)
      Transfus Med. 2011 Apr;21(2):116-23. (PMID: 21073580)
      Chest. 2012 Feb;141(2 Suppl):e152S-e184S. (PMID: 22315259)
      Haematologica. 2012 Oct;97(10):1501-6. (PMID: 22491734)
      Transfusion. 2013 Jul;53(7):1451-8; quiz 1450. (PMID: 23067393)
      Circulation. 2013 Sep 10;128(11):1234-43. (PMID: 23935011)
      Thromb Haemost. 2014 Feb;111(2):233-9. (PMID: 24154891)
      JAMA. 2015 Feb 24;313(8):824-36. (PMID: 25710659)
      Lancet. 2015 May 23;385(9982):2077-87. (PMID: 25728933)
      J Thromb Haemost. 2016 Jan;14(1):211-4. (PMID: 26391431)
      Neurocrit Care. 2016 Feb;24(1):6-46. (PMID: 26714677)
      Am J Emerg Med. 2016 Aug;34(8):1736.e1-3. (PMID: 26806175)
      Neurocrit Care. 2017 Feb;26(1):64-69. (PMID: 27052728)
      J Neuroimaging. 2017 Jan;27(1):144-148. (PMID: 27300754)
      Lancet Neurol. 2016 May;15(6):566-73. (PMID: 27302126)
      Neurocrit Care. 2017 Dec;27(3):334-340. (PMID: 28660341)
      J Thromb Thrombolysis. 2018 Feb;45(2):300-305. (PMID: 29164374)
      J Am Coll Cardiol. 2017 Dec 19;70(24):3042-3067. (PMID: 29203195)
    • Contributed Indexing:
      Keywords: Hemorrhage; PCC; Prothrombin complex concentrate; Reversal; Warfarin
    • Accession Number:
      0 (Anticoagulants)
      0 (Blood Coagulation Factors)
      0 (Heparin Antagonists)
      37224-63-8 (prothrombin complex concentrates)
      5Q7ZVV76EI (Warfarin)
    • Publication Date:
      Date Created: 20181117 Date Completed: 20190617 Latest Revision: 20200225
    • Publication Date:
      20231215
    • Accession Number:
      10.1007/s11239-018-1768-1
    • Accession Number:
      30443817