Published online before print January 26, 2006, doi: 10.1161/01.STR.0000204120.79399.72
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(Stroke. 2006;37:852.)
© 2006 American Heart Association, Inc.
Original Contributions |
Outcome and Symptomatic Bleeding Complications of Intravenous Thrombolysis Within 6 Hours in MRI-Selected Stroke Patients
Comparison of a German Multicenter Study With the Pooled Data of ATLANTIS, ECASS, and NINDS tPA Trials
From the Klinik und Poliklinik für Neurologie (G.T.), Neurozentrum, Universitäsklinikum Hamburg-Eppendorf, Hamburg, Germany; Neuroradiologische Abteilung (J.F., T.K., H.Z.), Klinik und Poliklinik für Radiologie, Universitätsklinikum Hamburg-Eppendorf, Martinistr., Hamburg, Germany; Neurologische Klinik (C.S., E.J., P.A.R., W.H., P.D.S.), Universitäsklinikum Heidelberg, Germany; Klinik und Poliklinik für Diagnostische und Interventionelle Neuroradiologie (J.B.F.), Zentrum für Bildgebende Diagnostik und Intervention Universitätsklinikum Heidelberg, Germany; Klinik und Poliklinik für Neurologie der Universität zu Köln (J.S., O.Z.-W.), Köln, Germany; Boehringer Ingelheim Pharma GmbH & Co. KG (E.B.), Ingelheim am Rhein, Germany; Neurologische Universitätsklinik (C.W.), Freiburg, Germany; and Neurologische Klinik (J.R.), Klinikum Minden, Germany.
Correspondence to Götz Thomalla, Neuro-Zentrum, Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, D-20246 Hamburg, Germany. E-mail thomalla{at}uke.uni-hamburg.de
Background and Purpose— We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials.
Methods— Patients were examined by perfusion-weighted and diffusion-weighted imaging 
6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials.
Results— From 174 MRI-selected tPA patients, 62% (n=108) were treated in 3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36]; P<0.001) and pooled tPA patients (40% [95% CI, 37 to 42]; P=0.046). Odds ratios for favorable outcome in the MRI-selected tPA group were 1.82 (1.32 to 2.51) compared with the pooled placebo and 1.39 (1.01 to 1.92) compared with the pooled tPA group. The rate of symptomatic intracerebral hemorrhage in MRI-selected tPA patients (3% [95% CI, 0 to 5]) was lower than in the pooled tPA group (8% [95% CI, 7 to 10]; P=0.012) and comparable to the pooled placebo group (2% [95% CI, 1 to 3]; P=0.392).
Conclusions— This study supports that it is safe and effective to expand the time window for IV-tPA up to 6 hours in patients with tissue at risk as defined by MRI.
Key Words: magnetic resonance imaging, diffusion-weighted • magnetic resonance imaging, perfusion-weighted • outcome • stroke, acute • thrombolytic therapy • tissue plasminogen activator
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