Sonal Singh1, Amit Nautiyal2, Kathy W Belk3. 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@umassmemorial.org. 2. Department of Medicine, Pulmonary and Critical Care, Albany Medical College, Albany, NY, USA. 3. Vizient Inc., Health Data Analytics, Irving, TX, USA.
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.
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.
Authors: Neena S Abraham; Alan N Barkun; Bryan G Sauer; James Douketis; Loren Laine; Peter A Noseworthy; Jennifer J Telford; Grigorios I Leontiadis Journal: J Can Assoc Gastroenterol Date: 2022-03-17