on behalf of the TRISP collaborators
In recent RCTs intravenous thrombolysis (IVT) beyond 4.5 hours of stroke onset was safe and effective, if patient selection was based on distinct imaging criteria. However, real-world data on safety of IVT beyond 4.5 hours are scarce. We aimed at determining the probability of symptomatic intracranial hemorrhage (sICH), poor functional outcome and mortality in patients treated in the extended time window outside of a RCT setting.
Data of ischemic stroke patients treated with IVT from the prospective ThRombolysis in Ischaemic Stroke Patients (TRISP) registry were used. We compared patients treated between 0-4.5 hours with those treated >4.5-9 hours after stroke onset using sICH (ECASS-II-criteria), poor 3-month outcome (modified Rankin Scale 3-6) and mortality as outcomes. We calculated adjusted OR with 95%-CI using logistic regression models.
Of 15’827 patients, 15’164 (95.8%) received IVT within 4.5 hours and 663 (4.2%) between >4.5-9 hours. Median age (73 vs 73) and median NIHSS (8 vs 8) was alike in both groups. The probability of sICH (ORadjusted 0.80[0.53-1.22]), poor 3-month outcome (ORadjusted 0.96[0.79-1.17]) and mortality (ORadjusted 0.81[0.61-1.07]) did not differ significantly. No independent association was found between increasing stroke-onset to treatment intervals (by 30 minutes) and any outcome.
IVT-treatment in stroke patients between >4.5-9 hours after stroke onset was safe and not associated with worse functional outcome or mortality in this large real-world dataset. Our results suggest that in experienced stroke centers, current methods of patient selection for IVT in the extended time window seem to be appropriate.
Not applicable