Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Background: Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016.

Objective: Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada.

Patients/methods: We performed a retrospective health records review of all idarucizumab use, excluding use in those <18 years of age, between May 16, 2016, and August 1, 2019, at six Ontario tertiary care hospitals. The primary outcome was mortality. The secondary outcomes were in-hospital arterial thrombotic event (ATE), in-hospital venous thromboembolism (VTE), length of hospital stay, and length of critical care stay.

Results: A total of 85 patients received idarucizumab during the study period for the following indications: 37 (43.5%) for spontaneous bleeding, 28 (32.9%) for traumatic bleeding, 11 (12.9%) for emergency surgeries/procedures, 5 (5.9%) for elective surgeries/procedures, and 4 (4.7%) for other indications. Nineteen patients (22.4%; 95% confidence interval [CI], 14.8%-32.3%) did not survive their hospitalization. During hospitalization, two patients (2.4%; 95% CI, 0.7%-8.2%) had ATE, and three patients (3.5%; 95% CI, 1.2%-9.9%) had VTE. The median length of stay was 8 (interquartile range [IQR], 2.5-13) days in hospital and 3 (IQR, 2-5) days in critical care.

Conclusions: Compared with clinical trial data, we found a numerically higher rate of mortality and similar rate of ATE and VTE among patients treated with idarucizumab in the real world.