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Idarucizumab for Dabigatran Reversal.

Publication ,  Journal Article
Pollack, CV; Reilly, PA; Eikelboom, J; Glund, S; Verhamme, P; Bernstein, RA; Dubiel, R; Huisman, MV; Hylek, EM; Kamphuisen, PW; Kreuzer, J ...
Published in: N Engl J Med
August 6, 2015

BACKGROUND: Specific reversal agents for non-vitamin K antagonist oral anticoagulants are lacking. Idarucizumab, an antibody fragment, was developed to reverse the anticoagulant effects of dabigatran. METHODS: We undertook this prospective cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who had serious bleeding (group A) or required an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the determination at a central laboratory of the dilute thrombin time or ecarin clotting time. A key secondary end point was the restoration of hemostasis. RESULTS: This interim analysis included 90 patients who received idarucizumab (51 patients in group A and 39 in group B). Among 68 patients with an elevated dilute thrombin time and 81 with an elevated ecarin clotting time at baseline, the median maximum percentage reversal was 100% (95% confidence interval, 100 to 100). Idarucizumab normalized the test results in 88 to 98% of the patients, an effect that was evident within minutes. Concentrations of unbound dabigatran remained below 20 ng per milliliter at 24 hours in 79% of the patients. Among 35 patients in group A who could be assessed, hemostasis, as determined by local investigators, was restored at a median of 11.4 hours. Among 36 patients in group B who underwent a procedure, normal intraoperative hemostasis was reported in 33, and mildly or moderately abnormal hemostasis was reported in 2 patients and 1 patient, respectively. One thrombotic event occurred within 72 hours after idarucizumab administration in a patient in whom anticoagulants had not been reinitiated. CONCLUSIONS: Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes. (Funded by Boehringer Ingelheim; RE-VERSE AD ClinicalTrials.gov number, NCT02104947.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 6, 2015

Volume

373

Issue

6

Start / End Page

511 / 520

Location

United States

Related Subject Headings

  • beta-Alanine
  • Thrombosis
  • Prospective Studies
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Hemorrhage
  • General & Internal Medicine
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Pollack, C. V., Reilly, P. A., Eikelboom, J., Glund, S., Verhamme, P., Bernstein, R. A., … Weitz, J. I. (2015). Idarucizumab for Dabigatran Reversal. N Engl J Med, 373(6), 511–520. https://doi.org/10.1056/NEJMoa1502000
Pollack, Charles V., Paul A. Reilly, John Eikelboom, Stephan Glund, Peter Verhamme, Richard A. Bernstein, Robert Dubiel, et al. “Idarucizumab for Dabigatran Reversal.N Engl J Med 373, no. 6 (August 6, 2015): 511–20. https://doi.org/10.1056/NEJMoa1502000.
Pollack CV, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511–20.
Pollack, Charles V., et al. “Idarucizumab for Dabigatran Reversal.N Engl J Med, vol. 373, no. 6, Aug. 2015, pp. 511–20. Pubmed, doi:10.1056/NEJMoa1502000.
Pollack CV, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam C-W, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511–520.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 6, 2015

Volume

373

Issue

6

Start / End Page

511 / 520

Location

United States

Related Subject Headings

  • beta-Alanine
  • Thrombosis
  • Prospective Studies
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Hemorrhage
  • General & Internal Medicine
  • Female