Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study

Am J Cardiovasc Drugs. 2020 Apr;20(2):161-168. doi: 10.1007/s40256-019-00360-6.


Background: Idarucizumab reverses the anticoagulant effect of dabigatran, but few comparative studies have reported on clinical outcomes with idarucizumab.

Objective: Our objective was to determine the effect of idarucizumab on clinical outcomes.

Methods: We conducted a retrospective cohort study in a nationally representative sample of hospitals in the United States. The study population included adults ≥ 18 years who were hospitalized for dabigatran-associated major bleeding between January 1, 2015 and December 31, 2017. We compared idarucizumab-exposed patients to the unexposed group. Our primary outcome of interest was in-hospital mortality.

Results: We included 266 exposed and 1345 non-exposed participants across 271 hospitals. Among participants with gastrointestinal bleeding, there was no statistically significant difference in the odds of in-hospital mortality [9/153 (5.9%) vs 37/1124 (3.3%); adjusted odds ratio = 1.39, 95% confidence interval 0.51-3.45] between the idarucizumab-exposed and non-exposed groups. Among participants with intracranial bleeding, there was an excess of in-hospital mortality [13/112 (11.6%) vs 6/217 (2.8%)] associated with idarucizumab exposure, but limitations include sparse data and the inability to rule out residual confounding or confounding by disease severity.

Conclusions: Among a large nationally representative sample of adult patients with dabigatran-associated major bleeding in the United States, we found no difference in in-hospital mortality among patients with gastrointestinal bleeding associated with idarucizumab exposure. An excess risk of in-hospital mortality associated with idarucizumab exposure among participants with intracranial bleeding deserves further exploration.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Cohort Studies
  • Dabigatran / administration & dosage
  • Dabigatran / adverse effects*
  • Female
  • Gastrointestinal Hemorrhage / chemically induced
  • Gastrointestinal Hemorrhage / drug therapy*
  • Gastrointestinal Hemorrhage / mortality
  • Hospital Mortality
  • Humans
  • Intracranial Hemorrhages / chemically induced
  • Intracranial Hemorrhages / drug therapy*
  • Intracranial Hemorrhages / mortality
  • Male
  • Retrospective Studies
  • Severity of Illness Index
  • Treatment Outcome


  • Antibodies, Monoclonal, Humanized
  • idarucizumab
  • Dabigatran