Intravenous Thrombolysis in Patients Taking Direct Oral Anticoagulation Treatment Before Stroke Onset: Results from the Safe Implementations of Treatments in Stroke International Stroke Registry

Abstract

Objectives: Intravenous thrombolysis (IVT) is contraindicated for acute ischemic stroke (AIS) patients taking direct oral anticoagulants (DOACs) within 48 hours before index stroke. Limited data exist on off-label use of IVT for these patients. We compared the safety and outcomes of IVT in AIS patients with DOAC treatment and patients with no OAC before index stroke.

Methods: We analyzed data from the Safe Implementations of Treatments in Stroke (SITS) International Stroke Thrombolysis Registry during 2013-2024. Outcomes were symptomatic intracerebral hemorrhage (SICH) by the SITS Monitoring Study and European Cooperative Acute Stroke Study II definitions, functional independency (modified Rankin Scale score 0-2), and death by 3 months. Propensity score matching with a nearest neighbor matching algorithm with a ratio of 1:2 was used for relevant clinical variables. We also analyzed the time from last DOAC dose to IVT treatment.

Results: A total of 1,311 DOAC and 129,384 no OAC patients were included. We matched 894 patients with DOAC to 1,788 with no OAC. The mean age was 75 years versus 76 years, and the median National Institutes of Health Stroke Scale score 11 versus 12, respectively. Patients with DOAC had a similar proportion of outcomes compared with patients with no OAC: SICH per SITS Monitoring Study (1.1 vs 1.5%, p = 0.50), SICH per European Cooperative Acute Stroke Study II (4.0 vs 4.3%, p = 0.82), any parenchymal hematoma (6.3 vs 7.8, p = 0.22), and functional independency (47.9 vs 46.4%, p = 0.59) and death (25.1 vs 24.0%, p = 0.65) at 3-month follow-up. The time from last DOAC dose to IVT did not affect outcomes.

Interpretation: In this observational study, we did not find any difference in outcomes after IVT therapy in AIS patients with DOAC compared with no OAC treatment before index stroke. ANN NEUROL 2025;97:1205-1214.

Fig 1

Study flow chart. AIS = acute ischemic stroke; DOAC = direct acting oral anticoagulants; IVT = intravenous thrombolysis; OAC = oral anticoagulants. [Color figure can be viewed at www.annalsofneurology.org]

Fig 2

Modified Rankin Scale (mRS) score distribution after propensity score matching for the study population. Solid black line shows limit between mRS score 2 and 3. DOAC = direct acting oral anticoagulants; mRS = modified Rankin Scale; OAC = oral anticoagulants. [Color figure can be viewed at www.annalsofneurology.org]