PB0699 - Idarucizumab for Dabigatran Reversal: a Systematic Review and Meta-analysis of Indications and Outcomes

Background: Idarucizumab has been approved to rapidly reverse the anticoagulant effect of dabigatran. However, there is insufficient insight into the effectiveness and safety of idarucizumab.

Aims: This systematic review and meta-analysis aims to evaluate the use and outcomes of idarucizumab.

Methods: A systematic literature search in the MEDLINE (PubMed), Embase, Web of Science, Cochrane Library, Emcare and Academic Search Premier databases was performed from inception to 08-09-2022. Original studies including patients prescribed idarucizumab, evaluating prescription indications, appropriateness of prescriptions, hemostatic efficacy, the need for repeated administration, or the occurrence of adverse events (e.g. thromboembolic events) were eligible. Case-reports and studies performed in patients under 18 years or in healthy volunteers were excluded. Study selection and data extraction were performed by two independent reviewers. Pooled estimates were calculated using the random-effects model, after Freeman-Tukey double arcsine transformation.

Results: Twenty-five studies, comprising a total of 3465 patients, were included. Idarucizumab was prescribed for bleeding (63.1%, 95%CI 57.0-69.0%), invasive procedures (30.5%, 95%CI: 24.1-37.2%), thrombolysis or thrombectomy (2.0-27.3%), dabigatran intoxication without bleeding (3.6-7.0%), or unspecified reasons (0.4-18.8%). Overall, 4.1% (95%CI 0.8-9.0%) of prescription indications were reported to be inappropriate. Hemostatic effectiveness was achieved in 77.7% (95%CI 66.7-87.2%) and peri-procedural hemostasis was normal in 98.5% (95%CI 86.6-100%) of patients. A repeated dose was administered in 0.5% (95%CI 0.0-2.0%) of cases. The pooled incidences of all-cause mortality and thromboembolic events at any follow-up duration were 15.4% (95%CI 11.5-19.6%) and 2.2%, respectively (95%CI 1.0-3.8%; Figures 1 and 2).

Conclusion(s): Idarucizumab was mainly prescribed in the setting of bleeding. The reported hemostatic effectiveness was good, especially perioperatively, and the incidence of thromboembolic events was low. Patients with dabigatran-associated major bleeding or requiring an urgent medical procedure nonetheless face a high mortality risk.