Perioperative Management of Dabigatran: A Prospective Cohort Study.

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  • Additional Information
    • Corporate Authors:
      Periop Dabigatran Study Group
    • Source:
      Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0147763 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1524-4539 (Electronic) Linking ISSN: 00097322 NLM ISO Abbreviation: Circulation Subsets: MEDLINE
    • Publication Information:
      Publication: Hagerstown, MD : Lippincott Williams & Wilkins
      Original Publication: [Dallas, Tex., etc., American Heart Association, etc.]
    • Subject Terms:
      Disease Management*; Antithrombins/*blood ; Benzimidazoles/*blood ; Perioperative Care/*methods ; beta-Alanine/*analogs & derivatives; Aged ; Aged, 80 and over ; Antithrombins/administration & dosage ; Antithrombins/adverse effects ; Benzimidazoles/administration & dosage ; Benzimidazoles/adverse effects ; Cohort Studies ; Dabigatran ; Female ; Hemorrhage/blood ; Hemorrhage/chemically induced ; Hemorrhage/prevention & control ; Humans ; Male ; Middle Aged ; Prospective Studies ; Thromboembolism/blood ; Thromboembolism/prevention & control ; beta-Alanine/administration & dosage ; beta-Alanine/adverse effects ; beta-Alanine/blood
    • Abstract:
      Background: The perioperative management of dabigatran in clinical practice is heterogeneous. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol.
      Methods and Results: Patients treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was prespecified according to the complexity of the surgery and consequences of a bleeding complication. Patients were followed up for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism, and death. We included 541 cases: 324 procedures (60%) with standard risk of bleeding and 217 procedures (40%) with increased risk of bleeding. The last dose of dabigatran was at 24, 48, or 96 hours before surgery according to the protocol in 46%, 37%, and 6%, respectively, of the patients. Resumption was timed according to protocol in 77% with 75 mg as the first dose on the day of procedure in 40% of the patients. Ten patients (1.8%; 95% confidence interval, 0.7-3.0) had major bleeding, and 28 patients (5.2%; 95% confidence interval, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in 1 patient (0.2%; 95% confidence interval, 0-0.5), and there were 4 deaths unrelated to bleeding or thrombosis. Bridging was not used preoperatively but was administered in 9 patients (1.7%) postoperatively.
      Conclusion: Our protocol for perioperative management of dabigatran appears to be effective and feasible.
      (© 2015 American Heart Association, Inc.)
    • Contributed Indexing:
      Keywords: dabigatran; hemorrhage; medication adherence; surgery
    • Accession Number:
      0 (Antithrombins)
      0 (Benzimidazoles)
      11P2JDE17B (beta-Alanine)
      I0VM4M70GC (Dabigatran)
    • Publication Date:
      Date Created: 20150514 Date Completed: 20150930 Latest Revision: 20220318
    • Publication Date:
      20231215
    • Accession Number:
      10.1161/CIRCULATIONAHA.115.015688
    • Accession Number:
      25966905