No increased risk of symptomatic intracerebral hemorrhage after thrombolysis in patients with European Cooperative Acute Stroke Study (ECASS) exclusion criteria.

BACKGROUND AND PURPOSE: The European Cooperative Acute Stroke Study (ECASS) III trial used additional exclusion criteria not present in current guidelines for thrombolytic therapy in the United States (age >80 years; National Institutes of Health Stroke Scale >25, combination of previous stroke and diabetes, aggressive measures required to control blood pressure [intravenous infusion], and oral anticoagulant treatment). We tested the hypothesis that thrombolysis is not safe in patients with 1 of the additional exclusion criteria. METHODS: All patients treated with intravenous tissue-type plasminogen activator for acute stroke at our center between June 2006 and June 2010 were identified (n=191), and stratified based on presence of each of the exclusion criteria. Primary outcomes were rate of symptomatic intracerebral hemorrhage and in-hospital mortality. Additionally, patients with and without symptomatic intracerebral hemorrhage were analyzed for differences in baseline characteristics. RESULTS: No exclusion criterion was associated with increased risk of symptomatic intracerebral hemorrhage. Symptomatic intracerebral hemorrhage was associated with atrial fibrillation (5 of 9 [55%], versus 35 of 182 [19.2%]; P=0.021), larger final infarct volume (mean 173 mL(3) versus 42 mL(3); P=0.0002), and elevated glucose (mean 166 mg/dL versus 127 mg/dL; P=0.038). There was higher mortality in patients >80 years (5 of 31 [16%] versus 6 of 160 [4%]; P=0.0186) and those with National Institutes of Health Stroke Scale >25 (2 of 5 [40%] versus 7 of 159 [4.4%]; P=0.025). CONCLUSIONS: In our cohort, none of the more stringent exclusion criteria from ECASS III were associated with increased risk of symptomatic intracerebral hemorrhage. Prospective randomized studies are needed clarify the safety and efficacy of tissue-type plasminogen activator in these patients through all treatment time windows.

Intravenous rt-PA is not associated with increased risk of hemorrhage in patients with intracranial aneurysms.

BACKGROUND AND PURPOSE: The presence of an intracranial aneurysm is listed as an exclusion criterion for the administration of recombinant tissue-plasminogen activator (rt-PA). This study was designed to test the hypothesis that the administration of rt-PA is safe in patients who have an unruptured intracranial aneurysm. METHODS: We performed a retrospective analysis of all acute ischemic stroke patients treated with rt-PA at our tertiary care academic medical center from June 2006 to June 2010 who also received intracranial vessel imaging. Baseline clinical characteristics were prospectively determined. Identification of hemorrhage and the presence of aneurysm were obtained from radiology report, and neuro-imaging findings were confirmed by study investigators. Symptomatic intracerebral hemorrhage (sICH) was defined according to National Institutes of Neurological Disorders and Stroke criteria. RESULTS: Five percent of patients (8/172) had at least one intracranial aneurysm on vessel imaging. A total of seven patients (4 %) had sICH. There was no significant difference in intracranial aneurysms between patients with or without sICH [1/7 (14 %) vs. 7/165 (4.2 %), p = 0.29]. In one patient with sICH and an intracranial aneurysm, the location of hemorrhage was distant from the aneurysm. The only predictors found for sICH in our cohort were atrial fibrillation (p = 0.03) and infarct size (p = 0.0004). CONCLUSIONS: Incidental intracranial aneurysms are common in patients who were present with acute ischemic stroke and not associated with sICH in our population. The concern that these patients are at increased risk of hemorrhage after thrombolysis may not be warranted.