From the Department of Vascular Diseases, University Medical Centre Ljubljana, Ljubljana (NV, AM, MB-M), Department of Plastic and Reconstructive Surgery, University Medical Centre Maribor, Maribor (MG), Department of Anaesthesiology and Reanimation, Trbovlje General Hospital, Trbovlje (KKU), Department of Anaesthesiology, Celje General Hospital, Celje (UŽ), Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana (PG, AS), Division of Neurology, University Medical Centre Ljubljana, Ljubljana (SF), Department of Cardiology and Angiology, University Medical Centre Maribor, Maribor (VN), General Hospital, Dr. Franca Derganca Nova Gorica, Šempeter pri Gorici (ND) and Department of Neurology, Celje General Hospital, Celje, Slovenia (IEK).
Eur J Anaesthesiol. 2020 Oct;37(10):874-878. doi: 10.1097/EJA.0000000000001185.
Real-life experience with idarucizumab, which reverses the anticoagulant effect of dabigatran, is currently limited.
To evaluate efficacy and safety of the clinical use of idarucizumab after its availability in Slovenia.
We analysed consecutive cases treated with idarucizumab in Slovenia from January to October 2016. The decision to reverse dabigatran with idarucizumab was made by the treating clinicians, as was the assessment of clinical outcomes and blood sampling/monitoring (activated partial thromboplastin time, thrombin time and diluted thrombin time) before and after use.
Idarucizumab was used in 17 cases. One patient was treated with the antidote twice with an interval of 2 months between treatments. The indications for idarucizumab use were: emergency surgery (4/17), severe bleeding (11/17; seven with intracranial bleeding) and ischaemic stroke (2/17). During surgery, no excessive bleeding was reported. Five patients died due to cardiogenic, haemorrhagic or septic shock, intracranial bleeding or multiple organ failure. Among cases with laboratory data available, baseline coagulation tests were prolonged in 12/13 cases with bleeding or emergency surgery. After idarucizumab administration, normal coagulation parameters were confirmed in 10/11. However, re-occurrence of dabigatran effect was noted later in four patients with creatinine clearance less than 30 ml min, and one patient with persistent bleeding required retreatment with idarucizumab.
Our first experiences with idarucizumab use in daily-care settings support a rapid and efficient decrease in the anticoagulant effect of dabigatran in emergency situations. Late re-occurrence of dabigatran effect was noted in a subset of patients with severe renal failure.
达比加群酯的逆转剂依达鲁单抗在现实生活中的应用经验目前有限。
评估依达鲁单抗在斯洛文尼亚上市后的临床应用疗效和安全性。
我们分析了 2016 年 1 月至 10 月期间在斯洛文尼亚使用依达鲁单抗治疗的连续病例。逆转达比加群酯的决定由主治临床医生做出，同时评估了临床结果和使用前后的血液取样/监测（活化部分凝血活酶时间、凝血酶时间和稀释凝血酶时间）。
17 例患者使用了依达鲁单抗。一名患者在两次治疗之间间隔 2 个月的情况下接受了两次解毒剂治疗。使用依达鲁单抗的指征为：急诊手术（4/17）、严重出血（11/17；7 例颅内出血）和缺血性脑卒中（2/17）。在手术期间，没有报告过度出血。由于心源性、出血性或脓毒性休克、颅内出血或多器官衰竭，有 5 例患者死亡。在有实验室数据的病例中，有出血或急诊手术的 12/13 例患者的基线凝血检测延长。依达鲁单抗给药后，10/11 例患者的凝血参数恢复正常。然而，4 例清除率小于 30ml/min 的患者和 1 例持续出血的患者随后出现达比加群酯作用的再次发生，需要再次使用依达鲁单抗治疗。
我们在日常医疗环境中使用依达鲁单抗的初步经验支持在紧急情况下快速有效地降低达比加群酯的抗凝作用。在一组严重肾功能衰竭的患者中，注意到达比加群酯作用的迟发性再发生。
