Sake J van der Wall1, Nienke van Rein2, Bart van den Bemt3, Marieke J H A Kruip4, Karina Meijer5, Liane C J Te Boome6, Tim A Simmers7, A Marco W Alings8, Robert Tieleman9, Frederikus A Klok1, Menno V Huisman1, Peter E Westerweel10. 1. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, RC Leiden, The Netherlands. 2. Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands. 3. Department of Pharmacy, Sint Maartens-kliniek and Radboud University Medical Center, Nijmegen, the Netherlands. 4. Department of Hematology, Erasmus Medical Center, Rotterdam, The Netherlands. 5. Department of Hematology, University Medical Center of Groningen, University of Groningen, Groningen, The Netherlands. 6. Department of Hematology, Haaglanden Medical Center, The Hague, The Netherlands. 7. Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands. 8. Department of Cardiology, Amphia Hospital, Breda, The Netherlands. 9. Department of Cardiology, Martini Hospital, Groningen, The Netherlands. 10. Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
Abstract
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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%) bleedingpatients 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 bleedingpatients 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. Published on behalf of the European Society of Cardiology. All rights reserved.