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Submitted on February 25, 2007
From the Department of Neurology (P.D.S., M.K.), University of Erlangen, Erlangen, Germany; the Department of Neurology (P.D.S., M.K.), University of Heidelberg, Heidelberg, Germany; the Departments of Neurology (G.T.) and Neuroradiology (J.F.), University of Hamburg, Hamburg, Germany; the Department of Neurology (O.Z.-W., J.S.), University of Cologne, Cologne, Germany; the Department of Neurology (T.N.-H., O.C.S.), University of Frankfurt, Frankfurt, Germany; and the Department of Neurology (C.A.M., M.R.), Autonomic University of Barcelona–Hospital Vall d’Hebron, Barcelona, Spain. * To whom correspondence should be addressed. E-mail: Peter.Schellinger{at}uk-erlangen.de.
Background and Purpose—The use of intravenous thrombolysis is restricted to a minority of patients by the rigid 3-hour time window. This window may be extended by using modern imaging-based selection algorithms. We assessed safety and efficacy of MRI-based thrombolysis within and beyond 3 hours compared with standard CT-based thrombolysis. Methods—Five European stroke centers pooled the core data of their CT- and MRI-based prospective thrombolysis databases. Safety outcomes were predefined as symptomatic intracranial hemorrhage and mortality. Primary efficacy outcome was a favorable outcome (modified Rankin Scale 0 to 1). We performed univariate and multivariate analyses for all end points, including age, National Institutes of Health Stroke Scale, treatment group (CT <3 hours, MRI <3 hours and >3 hours), and onset to treatment time as variables. Results—A total of 1210 patients were included (CT <3 hours: N=714; MRI <3 hours: N=316; MRI >3 hours: N=180). Median age, National Institutes of Health Stroke Scale, and onset to treatment time were 69, 67, and 68.5 years (P=0.66); 12, 13, and 14 points (P=0.019); and 130, 135, and 240 minutes (P<0.001). Symptomatic intracranial hemorrhage rates were 5.3%, 2.8%, and 4.4% (P=0.213); mortality was 13.7%, 11.7%, and 13.3% (P=0.68). Favorable outcome occurred in 35.4%, 37.0%, and 40% (P=0.51). Age and National Institutes of Health Stroke Scale were independent predictors for all safety and efficacy outcomes. The overall use of MRI significantly reduced symptomatic intracranial hemorrhage (OR: 0.520, 95% CI: 0.270 to 0.999, P=0.05). Beyond 3 hours, the use of MRI significantly predicted a favorable outcome (OR: 1.467; 95% CI: 1.017 to 2.117, P=0.040). Within 3 hours and for all secondary end points, there was a trend in favor of MRI-based selection over standard <3-hour CT-based treatment. Conclusion—Despite significantly longer time windows and significantly higher baseline National Institutes of Health Stroke Scale scores, MRI-based thrombolysis is safer and potentially more efficacious than standard CT-based thrombolysis.
Revised on March 23, 2007
Accepted on March 27, 2007
MRI-Based and CT-Based Thrombolytic Therapy in Acute Stroke Within and Beyond Established Time Windows. An Analysis of 1210 Patients
Peter D. Schellinger MD, PhD*;
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