Reversing dabigatran effect with idarucizumab to enable intravenous thrombolysis in patients with acute ischaemic stroke — a single centre experience

Abstract

Introduction.Our study analysed the safety and effectiveness of idarucizumab in enabling intravenous thrombolysis (IVT) in dabigatran-treated patients with acute ischaemic stroke (AIS).Clinical rationale for the study. New oral anticoagulants (NOAC), including dabigatran, are the first-choice treatment option for preventing ischaemic stroke in patients with non-valvular atrial fibrillation (AF). However, a significant percentage of AF patients develops AIS despite NOAC treatment. According to current guidelines, treatment with IVT is contraindicated in patients who have received NOAC within the last 48 hours. Idarucizumab is a fragment of a monoclonal antibody that reverses the anticoagulation effect of dabigatran. The latest research shows that it can enable safe and successful IVT in patients with recent dabigatran intake, but more data is needed to confirm the safety and effectiveness of such treatment. Material and methods.Our study included dabigatran-treated patients who received idarucizumab to allow AIS treatment with IVT in the University Hospital in Kraków (Poland) from December 2018 to June 2023. We gathered data on their past medical history, stroke severity, course of treatment and outcomes as defined by modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS) scores at discharge. A good functional outcome was defined as mRS 0-2 points at discharge. Results. This observational study included 19 patients (13 male and six female) with a median age of 74 (IQR = 13) years. In all patients (100%), the reason for dabigatran treatment was AF. A good functional outcome after treatment (mRS 0-2) was achieved in 68.4% of patients, but mRS was already ≥ 3 points before stroke onset in three (15.8%) patients. Haemorrhagic transformation of stroke occurred in three (15.8%) patients, including symptomatic intracranial haemorrhage in two (10.5%). The mortality rate was 5.3%. Conclusions and clinical implications.Our study results are in line with previous research on this topic, showing that IVT after idarucizumab can be successfully administered and is reasonably safe in dabigatran-treated patients with AIS.

Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update

“…HT was documented in 28 out of 310 patients (9.0%) ( 24 , 43 , 47 ), while the number of patients suffering from HT was not documented in a study done by Kikule et al ( 45 ). SICH developed in 10 out of 319 patients (3.1%) ( 24 , 43 , 45 , 47 ). The median NIHSS reduction between admission and discharge was 6 points in the case series reported by Włodarczyk et al ( 47 ) and 5 points in the case series reported by Kikule et al ( 45 ), while NIHSS at admission and discharge was not reported in another two studies ( 24 , 43 ).…”

“…For the case series, in-hospital mortality was reported in three papers ( 43 , 45 , 47 ) and was 11.94% on average, while it was not reported in a study written by Meinel et al ( 24 ). HT was documented in 28 out of 310 patients (9.0%) ( 24 , 43 , 47 ), while the number of patients suffering from HT was not documented in a study done by Kikule et al ( 45 ). SICH developed in 10 out of 319 patients (3.1%) ( 24 , 43 , 45 , 47 ).…”

“…Six articles with 326 patients suffering AIS while on dabigatran and treated with idarucizumab followed by IVT ( 24 , 42 , 43 , 45–47 ) were identified. Two studies provided individual patient data from 7 patients ( 42 , 46 ), whereas 4 case series reported outcomes from 319 patients ( 24 , 43 , 45 , 47 ). None of the patients described by Amin et al ( 42 ) suffered HT, suffered SICH, or died.…”

Long-term outcomes of mechanical thrombectomy in acute ischaemic stroke patients with concomitant malignancy

“…In all patients we collected the following data: demographics (age and sex) and stroke risk factor profile (hypertension, diabetes mellitus, history of myocardial infarction, atrial fibrillation, history of smoking, history of stroke or transient ischaemic attack, hypercholesterolemia, obesity) – the definitions of particular risk factors were presented in our previous study [ 10 ].…”

Reperfusion therapy of ischaemic strokes in oral anticoagulated patients: an expanding field in clinical practice

“…The low level of evidence (LOE) for clinical outcomes is the result of various factors, including a lack of randomised trials, diverse inclusion criteria in the available observational studies, and the relatively low number of patients in these studies [6][7][8][9][10][11][12][13][14][15]. Therefore, information on a new series of patients from different populations might be valuable in establishing management standards [16].…”