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Randomized Controlled Trial Comparative Study
IV vs. IA TPA in acute ischemic stroke with CT angiographic evidence of major vessel occlusion: a feasibility study.
- Souvik Sen, David Y Huang, Omid Akhavan, Susan Wilson, Piero Verro, and Sten Solander.
- UNC Stroke Center, Department of Neurology, University of North Carolina, 7001 NC Neuroscience Hospital, Chapel Hill, NC 27599-7025, USA. SenS@neurology.unc.edu
- Neurocrit Care. 2009 Jan 1;11(1):76-81.
Background And AimsStudies suggest that stroke patients with thrombus in a major cerebral vessel respond less favorably to intravenous (IV) thrombolysis. The purpose of this study was to test the feasibility of a protocol comparing IV versus intra-arterial (IA) recombinant tissue plasminogen activator (TPA) in an acute ischemic stroke with major vessel occlusion.MethodsConsecutive ischemic stroke patients presenting <3 h from symptom onset with major vessel occlusion on CT angiogram (CTA) were randomly assigned to IV TPA (per NINDS protocol) or IA TPA (22 mg over 2 h). Demographics, times to presentation and thrombolysis, presenting NIH stroke scale (NIHSS) and 90-day NIHSS, Barthel Index, and modified Rankin Scale were recorded. CT-scans at 24-h were reviewed for presence of hemorrhage. Recanalization was determined by post-procedure MR angiograms, which are obtained the day after thrombolytic therapy.ResultsSeven patients (median NIHSS = 16) were randomized to IV (N = 4) or IA (N = 3) TPA. There were no significant differences in the presentation NIHSS, time to presentation, or time to treatment between the two groups. Hemorrhage was noted in one patient in the IA group (asymptomatic) and one patient in the IV group (symptomatic). Recanalization was seen in all patients treated with IA TPA and none treated with IV TPA (P = 0.03, Fisher's Exact test).ConclusionsWe found that it is feasible to conduct a trial comparing IV vs. IA TPA in ischemic stroke patients with major vessel occlusion presenting <3 h from onset. Patients treated with IA TPA showed a trend toward higher rate of recanalization. A larger trial may be designed to test safety and effectiveness of IA TPA in this specific group of stroke patients.
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