IV thrombolysis after dabigatran reversal with idarucizumab in acute ischemic stroke was safe and comparable to IVT without prior oral anticoagulation (p=0.95).
Observational
Yes
Does dabigatran reversal with idarucizumab before IV thrombolysis improve safety and outcomes in patients with acute ischemic stroke on dabigatran?
IV thrombolysis after dabigatran reversal with idarucizumab appears safe and yields comparable outcomes to IV thrombolysis in patients not on prior oral anticoagulation.
p-value: p== 0.95
BACKGROUND AND OBJECTIVES: IV thrombolysis (IVT) is contraindicated in patients with acute ischemic stroke (AIS) while on dabigatran or other oral anticoagulant (OAC) treatment. Idarucizumab completely reverses the effect of dabigatran within minutes, without increasing the risk of thromboembolism. Limited data exist on IVT treatment after dabigatran reversal with idarucizumab. We aimed to investigate the safety and outcomes of IVT after dabigatran reversal in patients with AIS. METHODS: This is an observational study based on the Safe Implementation of Treatment in Stroke (SITS) International Stroke Thrombolysis Registry. Hospitals treating patients with AIS contributed data. The main outcome was safety as measured by any parenchymal hematoma (PH), symptomatic intracerebral hemorrhage (SICH) per SITS, and death within 3 months. The secondary outcome was functional independence defined as modified Rankin Scale scores of 0-2 at 3 months. Propensity score matching (PSM) was used to compare patients treated with dabigatran reversal to patients without prior OAC in primary analysis and for secondary analysis between patients treated with dabigatran reversal with idarucizumab to patients on dabigatran without reversal treatment. RESULTS: = 0.95). Secondary analysis showed similar results for all outcomes before and after PSM. DISCUSSION: In our observational study with patients with AIS, IVT treatment after dabigatran reversal was safe and had similar outcomes to IVT treatment without previous OAC. Furthermore, comparison between dabigatran reversal vs no reversal also indicates that IVT is safe for patients on dabigatran without idarucizumab reversal, which is currently being investigated in clinical trials. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that IVT after idarucizumab reversal in patients with AIS who took dabigatran within 48 hours of onset of symptoms is safe and comparable with those of patients with AIS not on prior oral anticoagulation.
Säflund et al. (2026) conducted an observational in Acute ischemic stroke. Idarucizumab before IV thrombolysis vs. No prior oral anticoagulant or dabigatran without reversal was evaluated on Any parenchymal hematoma, symptomatic intracerebral hemorrhage, and death within 3 months (p== 0.95). IV thrombolysis after dabigatran reversal with idarucizumab in acute ischemic stroke was safe and comparable to IVT without prior oral anticoagulation (p=0.95).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: