Thrombolysis In Stroke; Bad News Follows Good

It is only a few weeks since Genentech's Activase (alteplase), a thrombolytic, became the first approved drug treatment for ischemic stroke, after years of debate over the safety and efficacy of the procedure. But just as the initial flush of optimism subsided, a new study was published in the New England Journal of Medicine (July 18) which found that another thrombolytic, streptokinase, was not only ineffective but led to an increase in mortality.

The Multicenter Acute Stroke Trial - Europe (MAST-E) enrolled patients with moderate-to-severe ischemia in the region of the middle cerebral artery, who were randomized to receive either streptokinase (1.5 million units over a period of one hour) or placebo within six hours of the onset of the stroke. The primary efficacy endpoint was mortality and/or severe disability at six months, defined by a score of three or more on the Rankin scale, while the primary safety outcomes were mortality at 10 days and cerebral hemorrhage.

Excess Mortality MAST-E was halted early by the Data Monitoring Committee before the target enrollment was complete because an excess mortality in the treated group quickly became apparent. All the patients (156 in the streptokinase group and 154 in the placebo group) were evaluated at six months.