Idarucizumab achieved effective haemostasis in 67% of bleeding patients, and failure to achieve effective haemostasis was associated with higher mortality (RR 7.0; 95% CI 1.6-30).
Cohort (n=88)
Does idarucizumab improve haemostasis and clinical outcomes in patients requiring urgent dabigatran reversal in daily clinical practice?
In daily clinical practice, idarucizumab use was inappropriate in 28% of cases, but when used appropriately, effective haemostasis was achieved in 67% of bleeding patients and was associated with lower mortality.
Effect estimate: RR 7.0 (95% CI 1.6-30)
Absolute Event Rate: 43.8% vs 6.3%
AIMS: Because practice-based data on the usage of idarucizumab for urgent dabigatran reversal is unavailable, we evaluated the appropriateness of idarucizumab usage, its haemostatic effectiveness and clinical outcomes. METHODS AND RESULTS: An observational cohort study was performed including consecutive patients who were treated with idarucizumab between 2016 and 2018. Appropriate usage was assessed with predefined criteria. Post-reversal effectiveness was evaluated according to International Society on Thrombosis and Haemostasis (ISTH) recommendations. Patients were followed for 90 days for occurrence of thromboembolism, (re-)bleeding and death. Idarucizumab was used in 88 patients, of whom 53 (60%) presented with severe bleeding (20 gastrointestinal and 18 intracranial) and 35 (40%) requiring urgent surgical intervention. Use of idarucizumab was judged inappropriate in 25 patients (28%). Effective haemostasis was achieved in 32 of 48 (67%) bleeding patients in whom assessment was possible. Seven of 16 patients with major bleeding who did not achieve effective haemostasis (five intracranial) died, compared with two of 32 patients with effective haemostasis (relative risk 7.0, 95% confidence interval 1.6-30). Four patients (4.2%) developed thromboembolism 2 (2.1%) within 30 days and four patients (4.2%) re-bleeding, all within 10 days. Seventeen patients (19%) died; 10 (11%) within 5 days. CONCLUSION: In this practice-based cohort, idarucizumab use was considered inappropriate in 28% of patients. Effective haemostasis was achieved in two-third of bleeding patients and was associated with lower mortality risk. Clinical outcomes were similar to those observed in the RE-VERSE AD trial, comprising re-bleeds and thromboembolism, and a high-mortality rate.
Wall et al. (Wed,) conducted a cohort in Urgent dabigatran reversal for severe bleeding or urgent surgical intervention (n=88). Idarucizumab was evaluated on Mortality in patients without vs with effective haemostasis (RR 7.0, 95% CI 1.6-30). Idarucizumab achieved effective haemostasis in 67% of bleeding patients, and failure to achieve effective haemostasis was associated with higher mortality (RR 7.0; 95% CI 1.6-30).