Aim: To analyze the safety profile and clinical outcome of patients with acute cerebral ischemia who received open treatment with tissue plasminogen activator (rt-PA) in a hospital without previous experience.
Patients and methods: This prospective and observational study were realized from January 2004 to January 2007. A total of 1,704 consecutive patients with ischemic stroke were attended. 72 of them (4.2%) were treated with rt-PA within 3 hours from the symptoms onset. We analyzed age, vascular risk factors, initial and 24 hours neurological state by the National Institute of Health Stroke Scale (NIHSS), incidence of intracerebral hemorrhage and mortality and independence at 90 days. Patients were treated by neurologist and stroke monitoring was performed in the emergency area.
Results: Baseline median NIHSS was 16. At 24 hours, 53% of patients had improved = or > 4 points in the NIHSS and 33% showed = or > 10 points improvement or total recovery. The median time from stroke onset to rt-PA treatment was 160 minutes. Symptomatic intracerebral hemorrhage occurred in two patients (2.7%). Overall mortality at 90 days was 9.7%, but was due to hemorrhagic brain complications only in one case. At three months, 51% of patients were independent according to the modified Rankin scale.
Conclusions: Treatment of acute ischemic stroke within three hours with intravenous rt-PA is safe and is associated with favorable outcome when it is applied by neurologists following approved protocols even in hospitals without previous experience.