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Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study.

Publication ,  Journal Article
Levy, JH; van Ryn, J; Sellke, FW; Reilly, PA; Elsaesser, A; Glund, S; Kreuzer, J; Weitz, JI; Pollack, CV
Published in: Ann Surg
September 1, 2021

OBJECTIVE: To further examine anticoagulation reversal and clinical outcomes in dabigatran treated patients requiring urgent surgery or procedural interventions. BACKGROUND: Idarucizumab, a humanized monoclonal antibody fragment, reverses dabigatran anticoagulation. METHODS: Data from surgical and procedural patients in RE-VERSE AD, a multicenter, open-label, single-arm, prospective cohort of dabigatran reversal were evaluated. A total of 202 patients in this group received 5 g of idarucizumab before surgery or procedures. RESULTS: The interventions included 49 abdominal, 45 orthopedic, 34 vascular, 8 neurologic, and 4 genitourinary surgical procedures, or 29 catheter-based cases, 20 cases for drainage, and 8 diagnostic procedures. Five patients did not undergo their intended intervention after receiving idarucizumab. Complete reversal of the dabigatran anticoagulant effect occurred within minutes in almost all patients, with normal hemostasis in more than 91% of patients. The median time from the first vial of idarucizumab to surgery or procedures was less than 2 hours in all groups except neurosurgery, where it was 3.3 hours. Fresh frozen plasma and packed red cells were the most frequently transfused blood products. Postreversal thromboembolic events occurred in 10 (5%) patients at 30 days, 5 of whom had restarted anticoagulation before the event. Overall 30-day mortality was 12.6%. There were no serious adverse safety signals due to idarucizumab dosing. CONCLUSIONS: Idarucizumab facilitates management of patients requiring urgent procedures by providing rapid dabigatran reversal, and is the only agent of its class studied in surgical patients.

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Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

September 1, 2021

Volume

274

Issue

3

Start / End Page

e204 / e211

Location

United States

Related Subject Headings

  • Surgical Procedures, Operative
  • Surgery
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage
  • Female
  • Emergencies
  • Dabigatran
 

Citation

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MLA
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Levy, J. H., van Ryn, J., Sellke, F. W., Reilly, P. A., Elsaesser, A., Glund, S., … Pollack, C. V. (2021). Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study. Ann Surg, 274(3), e204–e211. https://doi.org/10.1097/SLA.0000000000003638
Levy, Jerrold H., Joanne van Ryn, Frank W. Sellke, Paul A. Reilly, Amelie Elsaesser, Stephan Glund, Jörg Kreuzer, Jeffrey I. Weitz, and Charles V. Pollack. “Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study.Ann Surg 274, no. 3 (September 1, 2021): e204–11. https://doi.org/10.1097/SLA.0000000000003638.
Levy JH, van Ryn J, Sellke FW, Reilly PA, Elsaesser A, Glund S, et al. Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study. Ann Surg. 2021 Sep 1;274(3):e204–11.
Levy, Jerrold H., et al. “Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study.Ann Surg, vol. 274, no. 3, Sept. 2021, pp. e204–11. Pubmed, doi:10.1097/SLA.0000000000003638.
Levy JH, van Ryn J, Sellke FW, Reilly PA, Elsaesser A, Glund S, Kreuzer J, Weitz JI, Pollack CV. Dabigatran Reversal With Idarucizumab in Patients Requiring Urgent Surgery: A Subanalysis of the RE-VERSE AD Study. Ann Surg. 2021 Sep 1;274(3):e204–e211.

Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

September 1, 2021

Volume

274

Issue

3

Start / End Page

e204 / e211

Location

United States

Related Subject Headings

  • Surgical Procedures, Operative
  • Surgery
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage
  • Female
  • Emergencies
  • Dabigatran