Thrombolysis with Alteplase 3 to 4.5 Hours after Acute Ischemic Stroke
Werner Hacke, M.D., Markku Kaste, M.D., Erich Bluhmki, Ph.D., Miroslav Brozman, M.D., Antoni Dávalos, M.D., Donata Guidetti, M.D., Vincent Larrue, M.D., Kennedy R. Lees, M.D., Zakaria Medeghri, M.D., Thomas Machnig, M.D., Dietmar Schneider, M.D., Rüdiger von Kummer, M.D., Nils Wahlgren, M.D., Danilo Toni, M.D., for the ECASS Investigators
Background Intravenous thrombolysis with alteplase is the onlyapproved treatment for acute ischemic stroke, but its efficacyand safety when administered more than 3 hours after the onsetof symptoms have not been established. We tested the efficacyand safety of alteplase administered between 3 and 4.5 hoursafter the onset of a stroke.
Methods After exclusion of patients with a brain hemorrhageor major infarction, as detected on a computed tomographic scan,we randomly assigned patients with acute ischemic stroke ina 1:1 double-blind fashion to receive treatment with intravenousalteplase (0.9 mg per kilogram of body weight) or placebo. Theprimary end point was disability at 90 days, dichotomized asa favorable outcome (a score of 0 or 1 on the modified Rankinscale, which has a range of 0 to 6, with 0 indicating no symptomsat all and 6 indicating death) or an unfavorable outcome (ascore of 2 to 6 on the modified Rankin scale). The secondaryend point was a global outcome analysis of four neurologic anddisability scores combined. Safety end points included death,symptomatic intracranial hemorrhage, and other serious adverseevents.
Results We enrolled a total of 821 patients in the study andrandomly assigned 418 to the alteplase group and 403 to theplacebo group. The median time for the administration of alteplasewas 3 hours 59 minutes. More patients had a favorable outcomewith alteplase than with placebo (52.4% vs. 45.2%; odds ratio,1.34; 95% confidence interval [CI], 1.02 to 1.76; P=0.04). Inthe global analysis, the outcome was also improved with alteplaseas compared with placebo (odds ratio, 1.28; 95% CI, 1.00 to1.65; P<0.05). The incidence of intracranial hemorrhage washigher with alteplase than with placebo (for any intracranialhemorrhage, 27.0% vs. 17.6%; P=0.001; for symptomatic intracranialhemorrhage, 2.4% vs. 0.2%; P=0.008). Mortality did not differsignificantly between the alteplase and placebo groups (7.7%and 8.4%, respectively; P=0.68). There was no significant differencein the rate of other serious adverse events.
Conclusions As compared with placebo, intravenous alteplaseadministered between 3 and 4.5 hours after the onset of symptomssignificantly improved clinical outcomes in patients with acuteischemic stroke; alteplase was more frequently associated withsymptomatic intracranial hemorrhage. (ClinicalTrials.gov number,NCT00153036
[ClinicalTrials.gov]
.)
Source Information
From the Department of Neurology, Universität Heidelberg, Heidelberg, Germany (W.H.); the Department of Neurology, Helsinki University Central Hospital, Helsinki (M.K.); the Department of Statistics, Boehringer Ingelheim, Biberach, Germany (E.B.); the Neurology Clinic, University Hospital Nitra, Nitra, Slovakia (M.B.); the Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Barcelona (A.D.); the Department of Neurology, Hospital of Piacenza, Piacenza, Italy (D.G.); the Department of Neurology, University of Toulouse, Toulouse, France (V.L.); the Faculty of Medicine, University of Glasgow, Glasgow, United Kingdom (K.R.L.); Boehringer Ingelheim, Reims, France (Z.M.); Boehringer Ingelheim, Ingelheim, Germany (T.M.); the Department of Neurology, Universität Leipzig, Leipzig, Germany (D.S.); the Department of Neuroradiology, Technische Universität Dresden, Dresden, Germany (R.K.); the Department of Neurology, Karolinska Institutet, Stockholm (N.W.); and the Department of Neurological Sciences, University La Sapienza, Rome (D.T.).
Address reprint requests to Dr. Hacke at the Department of Neurology, Im Neuenheimer Feld 400, D-69120 Heidelberg, Germany, or at werner.hacke{at}med.uni-heidelberg.de.
Thrombolysis 3 to 4.5 Hours after Acute Ischemic Stroke
Torbey M. T., Jauch E., Liebeskind D. S., the Acute Stroke Advisory Board of the National Stroke Association , Fitzpatrick A. E., Noone I., O'Shea D. D., Schwamm L. H., Fonarow G. C., Morris D. C., Hacke W., Kaste M., Toni D.
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N Engl J Med 2008;
359:2839-2841, Dec 25, 2008.
Correspondence
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