Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study.
Research article published in American journal of cardiovascular drugs : drugs, devices, and other interventions (2020)
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Idarucizumab reverses the anticoagulant effect of dabigatran, but few comparative studies have reported on clinical outcomes with idarucizumab. Our objective was to determine the effect of idarucizumab on clinical outcomes. We conducted a retrospective cohort study in a nationally representative sample of hospitals in the United States.
Why This Matters for Hirudotherapy
This US population-based retrospective cohort examined real-world outcomes of idarucizumab, the specific reversal agent for the direct thrombin inhibitor dabigatran, in adults hospitalized for dabigatran-associated major bleeding (266 exposed vs 1345 unexposed); it found no significant in-hospital mortality difference for gastrointestinal bleeding but observed an excess of in-hospital mortality with idarucizumab exposure in intracranial bleeding that the authors say warrants further exploration. The relevance to ASH is mechanistic and cautionary: direct thrombin inhibition is the same pharmacologic principle exploited by hirudin, the leech-derived anticoagulant at the heart of the medicinal-leech secretome story, so the difficulty and uncertain benefit of reversing such agents in catastrophic bleeding is directly pertinent to how leech-based anticoagulation would need to be managed clinically. As an observational cohort the abstract explicitly flags sparse data and possible residual confounding, especially for the intracranial-bleeding signal, so these findings are associations rather than causal proof, and the study does not test any leech therapy.
Citation
Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study.
Singh et al. · American journal of cardiovascular drugs : drugs, devices, and other interventions, 2020
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