First Real-world Study on the Efficacy and Safety of Idarucizumab in Malaysia

Introduction Idarucizumab is developed to neutralize the anticoagulant effects of dabigatran. Its availability in Malaysia has made it possible to manage life-threatening situations that necessitate immediate reversal of dabigatran in clinical practice. Aim The objective of this study was to assess the efficacy and safety of dabigatran reversal with idarucizumab. Methods This two-phase prospective-retrospective clinical observational study involved patients who received idarucizumab in two tertiary hospitals in Malaysia. The inclusion criteria were dabigatran-treated patients aged 18 years and older who received idarucizumab between April 2017 and December 2024. Descriptive statistics were used mainly, while the differences and association between study outcomes were analysed using Wilcoxon Rank test and Fisher’s Exact test. Results A total of 22 patients were enrolled into the study. Twenty patients had life-threatening bleeding and required immediate reversal of anticoagulation, while two patients required emergency surgery. Post idarucizumab administration, significant reductions in both activated partial thromboplastin time and prothrombin time were observed (p < 0.001). The majority (75%) of the patients achieved clinical resolution of bleeding and were discharged alive. No adverse reactions have been reported. The mortality rate was 22.7%, with renal impairment being significantly associated with mortality [normal VS renally impaired: 1(20%) VS 4(80%), p = 0.039]. Conclusion From our findings, idarucizumab was effective for dabigatran reversal and safe with no adverse effect observed.