This phase II study’s primary safety endpoint was the incidence of symptomatic intracerebral hemorrhage following alteplase treatment, which occurred in 1 of the 80 patients (1.25%), not a statistically significant difference when compared with the historical standard, the 2.4% rate seen in stroke patients treated with intravenous alteplase 3 to 4.5 hours after their known stroke onset in the ECASS III (European Cooperative Acute Stroke Study) (N Engl J Med. 2008 Sept 25;359[13]:1317-29). The rate of asymptomatic intracerebral hemorrhage was not significantly different between the new study and ECASS III, reported Dr. Lee H. Schwamm, director of TeleStroke & Acute Stroke Services at the Massachusetts General Hospital in Boston.
Based on this result, “we know this approach is safe, and we saw a signal of efficacy, but we really don’t know how effective it will be” until this approach to assessing unwitnessed-stroke patients by imaging undergoes testing in a phase III trial, cautioned Dr. Schwamm at the meeting, sponsored by the American Heart Association.
Future work will also examine whether similar results can be obtained by CT imaging, which would “open this approach to every U.S. emergency department,” Dr. Schwamm said. Although the MR diffusion-weighted imaging and FLAIR analyses used in the current study do not require anything more than standard MRI equipment and software, it remains less available than CT imaging at most U.S. hospitals, he said.
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