Clinical Effectiveness of Idarucizumab in Dabigatran Reversal

Abstract

AIM: Idarucizumab is a specific reversal agent for dabigatran. This study aims to evaluate the effectiveness and safety of idarucizumab in the reversal of dabigatran’s anticoagulant effects in clinical practice.

METHODS: This was a multi-centered, retrospective cohort study of patients hospitalized with a major bleed and taking dabigatran prior to admission. The intervention group of this cohort included patients who received idarucizumab. The control group included patients who did not receive idarucizumab and had an ICD-10 code for hospital admission involving a bleeding event and preadmission diagnosis of atrial fibrillation.

RESULTS: A total of 20 cases were included in the idarucizumab group and 18 cases in the control group. A greater proportion of patients receiving idarucizumab had achieved normalized activated partial thromboplastin time within 24 hours (100% vs. 0%; p = 0.005) and there was a trend towards fewer patients having received a transfusion of blood products compared to control (45.0% vs. 72.2%; p = 0.171). Length of hospital stay, in-hospital mortality and the proportion of patients that experienced a stroke, venous thromboembolism, hypersensitivity reaction, or ICU admission occurring in-hospital within 30 days were non-statistically different between the 2 groups.

CONCLUSION: The use of idarucizumab for the reversal of dabigatran for the management of major bleeding was effective in normalizing activated partial thromboplastin time. The trend towards lower rates of transfusion and higher rates of stroke or venous thromboembolism events with idarucizumab requires ongoing assessment. Future studies should continue to include transfusion rates and thrombotic events as outcome when assessing idarucizumab.