(Stroke. 1999;30:1326-1332.)
© 1999 American Heart Association, Inc.
Original Contributions |
From the Department of Clinical and Biological Neurosciences, Stroke Unit, INSERM U 438, University Hospital, Grenoble, France (A.J., M.H.); Service de Pharmacologie, Clinique EA 643, Claude Bernard University, Lyon, France (C.C., F.B.); Service de Neurologie, University Hospital, Clermont-Ferrand, France (A.D.); Service de Neurologie, University Hospital, Besançon, France (T.M.); and the Acute Stroke Unit, University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, UK (K.R.L.).
Correspondence to Assia Jaillard, Service de NeurologieUnité d'Urgences Cérébrovasculaires, Centre Hospitalier Universitaire de Grenoble, BP 217-38043 Grenoble Cedex, France. E-mail Assia.Jaillard{at}ujf-grenoble.fr
Background and PurposeHemorrhagic transformation (HT) is the most critical complication of thrombolytics in clinical trials in acute stroke. The aim of this study was to determine the rates and the predictors of HT in the Multicenter Acute Stroke TrialEurope (MAST-E) study.
MethodsWe performed a post hoc analysis of MAST-E data designed to assess the safety and efficacy of streptokinase administered intravenously within 6 hours of stroke onset. HT included all intracerebral hemorrhages and symptomatic hemorrhages (SHT) associated with clinical worsening. The predictors of HT and SHT were determined using multivariate modeling.
ResultsAmong the 310 patients included, 159 patients had HT and 37 SHT (97 and 33 in the streptokinase group and 62 and 4 in the placebo group, respectively). Patients with SHT had significantly more atrial fibrillation, diabetes mellitus, no heparin use, streptokinase treatment, and early CT signs. In the multivariate analysis, HT was predicted by early CT signs and streptokinase treatment. SHT was predicted by diabetes mellitus, early CT signs, streptokinase treatment, and the interaction between streptokinase treatment and decreased level of consciousness. Among the streptokinase-treated patients, the same predictors remained.
ConclusionsThe relative risks of HT after streptokinase were in the same range in MAST-E as in other streptokinase and tPA trials. Early CT signs were strong predictors of both HT and SHT, stressing that these patients are at high risk of bleeding. In our study, the predictors of HT and SHT were similar to those of tPA trials in acute stroke.
Key Words: cerebral hemorrhage clinical trials streptokinase stroke, acute
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