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

  • Original Research Article
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Abstract

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.

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Author information

Authors and Affiliations

  1. Department of Family Medicine and Community Health and Meyers Primary Care Institute, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655-0002, USA

    Sonal Singh

  2. Department of Medicine, Pulmonary and Critical Care, Albany Medical College, Albany, NY, USA

    Amit Nautiyal

  3. Vizient Inc., Health Data Analytics, Irving, TX, USA

    Kathy W. Belk

Authors
  1. Sonal Singh
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  2. Amit Nautiyal
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  3. Kathy W. Belk
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Corresponding author

Correspondence to Sonal Singh.

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Funding

No external funding was used in the preparation of this article.

Conflict of interest

Sonal Singh, Amit Nautiyal, and Kathy Belk declare that they have no potential conflicts of interest that might be relevant to the contents of this article.

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Appendix

Appendix

See Table 3.

Table 3 Coding algorithm for Idarucizumab.
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Singh, S., Nautiyal, A. & Belk, K.W. Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study. Am J Cardiovasc Drugs 20, 161–168 (2020). https://doi.org/10.1007/s40256-019-00360-6

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