THROMBOLYTIC THERAPY WITH STREPTOKINASE IN ACUTE ISCHEMIC STROKE

Background In patients with acute ischemic stroke, early treatment wit h thrombolytic agents is thought to permit reperfusion of ischemic neu rons and to promote recovery of function. The Multicenter Acute Stroke -Trial - Europe (MAST-E) was designed to assess the efficacy and safet y of streptokinase in patients with acute ischemic stroke. Methods Pat ients with moderate-to-severe ischemia in the territory of the middle cerebral artery were randomly assigned to receive streptokinase (1.5 m illion units over a period of one hour) or placebo within six hours af ter the onset of stroke. The primary efficacy outcome was a binary cri terion combining mortality and severe disability at six months, with s evere disability defined as a score of 3 or higher on the Rankin scale . The primary safety outcomes were mortality at 10 days and cerebral h emorrhage. Results All randomized patients (156 in the streptokinase g roup and 154 in the placebo group) were evaluated at six months. The i ncidence of the primary efficacy outcome was similar in the two groups (124 patients in the streptokinase group and 126 in the placebo group died or had a Rankin score greater than or equal to 3). However, the mortality rate at 10 days was significantly higher in the streptokinas e group than in the placebo group (34.0 percent vs. 18.2 percent, P=0. 002). The higher rate in the streptokinase group was mainly due to the hemorrhagic transformation of ischemic cerebral infarcts. At six mont hs, more deaths had occurred in the streptokinase group than in the pl acebo group (73 vs. 59, P=0.06). Conclusions In patients with acute is chemic stroke, treatment with streptokinase resulted in an increase in mortality. The routine use of streptokinase cannot be recommended in acute ischemic stroke. (C) 1996, Massachusetts Medical Society.