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To the Editor:I read with great interest the article by Higashida and colleagues on the trial design of studies to test intra-arterial thrombolysis.1 The authors are to be congratulated for their prodigious efforts to set standards for intra-arterial thrombolysis trials. Unfortunately, the evidence for using one of the traditional exclusion criteria should no longer be considered binding. The criterion in question is based on the ECASS trials on intravenous thrombolysis2 and the work of von Kummer and colleagues.3 It excludes patients with “an acute hypodense parenchymal lesion on CT or effacement of the cerebral sulci in more than one-third of the MCA territory or suspected stroke region.”Recent evidence from a retrospective analysis of the NINDS data, 4 however, showed that patients with early ischemic signs in more than one third of the above regions reacted even better to thrombolysis and it benefited most. Using the ASPECTS grading of stroke CT, Hill and colleagues …

Early Ischemic Signs Should Not Be Used as Exclusion Criteria in Thrombolysis Trials