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Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding.

Publication ,  Journal Article
Van der Wall, SJ; Lopes, RD; Aisenberg, J; Reilly, P; van Ryn, J; Glund, S; Elsaesser, A; Klok, FA; Pollack, CV; Huisman, MV
Published in: Circulation
February 5, 2019

BACKGROUND: Although dabigatran has a favorable risk-benefit profile compared with vitamin K antagonist therapy for venous thromboembolism and nonvalvular atrial fibrillation, major bleeding events, including gastrointestinal (GI) bleeding, may occur. Therefore, our aim was to provide insights into the efficacy and safety of idarucizumab for urgent dabigatran reversal in patients with major GI bleeding. METHODS: Patients with uncontrollable GI bleeding requiring reversal were enrolled from June 2014 through July 2016 in the RE-VERSE AD study (Reversal of Dabigatran Anticoagulant Effect With Idarucizumab), a prospective, multicenter, open-label study of idarucizumab, and were followed up for 90 days for primary and secondary outcomes. Patients were to receive a 5-g dose of intravenous idarucizumab, administered as 2 bolus infusions of 2.5 g no more than 15 minutes apart. The primary end point was the maximum reversal of dabigatran anticoagulation within 4 hours after administration of idarucizumab as measured by the dabigatran-specific assays diluted thrombin time and ecarin clotting time. Further end points included investigator-reported bleeding cessation within the first 24 hours and incidence of rebleeding, thromboembolic events, or mortality. RESULTS: GI bleeding occurred in 137 patients enrolled in RE-VERSE AD, of which 84% was adjudicated as major or life-threatening, 48 (35.0%) was upper GI tract in origin, 43 (31.4%) was lower GI in origin, and 46 (33.6%) was either both or unknown. Complete reversal of dabigatran was observed in 118 of 121 patients (97.5%) with an elevated diluted thrombin time at presentation and 95 of 131 patients (72.5%) with an elevated ecarin clotting time and was similar for upper and lower GI bleeding. Bleeding cessation within 24 hours was reported in 92 of 134 evaluable patients (68.7%) after a median duration of 2.4 hours (interquartile range, 2.0-3.9 hours). During the 90-day follow-up, 6 patients (4.4%) had a postreversal thromboembolic event, and 20 patients (14.6%) died. CONCLUSIONS: Idarucizumab showed a rapid and complete reversal of dabigatran activity in nearly all patients presenting with GI bleeding, facilitating emergency patient care without the additional presence of anticoagulation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02104947.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

February 5, 2019

Volume

139

Issue

6

Start / End Page

748 / 756

Location

United States

Related Subject Headings

  • Vitamin K
  • Venous Thromboembolism
  • United States
  • Risk Assessment
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Gastrointestinal Hemorrhage
  • Follow-Up Studies
 

Citation

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Van der Wall, S. J., Lopes, R. D., Aisenberg, J., Reilly, P., van Ryn, J., Glund, S., … Huisman, M. V. (2019). Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation, 139(6), 748–756. https://doi.org/10.1161/CIRCULATIONAHA.118.036710
Van der Wall, Sake J., Renato D. Lopes, James Aisenberg, Paul Reilly, Joanne van Ryn, Stephan Glund, Amelie Elsaesser, Frederikus A. Klok, Charles V. Pollack, and Menno V. Huisman. “Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding.Circulation 139, no. 6 (February 5, 2019): 748–56. https://doi.org/10.1161/CIRCULATIONAHA.118.036710.
Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, et al. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748–56.
Van der Wall, Sake J., et al. “Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding.Circulation, vol. 139, no. 6, Feb. 2019, pp. 748–56. Pubmed, doi:10.1161/CIRCULATIONAHA.118.036710.
Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748–756.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

February 5, 2019

Volume

139

Issue

6

Start / End Page

748 / 756

Location

United States

Related Subject Headings

  • Vitamin K
  • Venous Thromboembolism
  • United States
  • Risk Assessment
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Gastrointestinal Hemorrhage
  • Follow-Up Studies