Increasing use of rt-PA does not affect safety in acute stroke

Background: Intravenous thrombolysis with rt-PA improves outcome in acute ischemic stroke. In a prospective study we analyzed the annual frequency of rt-PA treatment, its safety, and early clinical outcome.

Methods: All patients admitted to our stroke unit (SU) from 1998 to 2003 were registered in a prospective data base. Documented data included patient age, sex, time interval until admission, initial therapy (e.g., thrombolysis), death, intracerebral hemorrhage, other complications, and score on the National Institute of Health Stroke Scale (NIHSS).

Results: From 1998 to 2003, a total of 112 patients were treated with systemic thrombolysis. The number of acute stroke patients admitted within 2.5 hours and therefore eligible for thrombolysis did not substantially change between 1998 and 2003. From 1998 to 2001 the percentage of acute stroke patients that received rt-PA was stable (12.6–16.9%). This percentage increased in 2002 (29.6%, p<0.05) and, again, in 2003 (42.1%, p<0.01). Of all treated patients, two developed symptomatic intracerebral hemorrhage within one hour of thrombolysis (1.8%) and five died three to seven days after thrombolysis (4.5%). The NIHSS score of patients receiving rt-PA significantly decreased during the acute treatment phase (14.2±5.1 to 8.0±5.9, p<0.001). A comparison of single years revealed that this NIHSS score reduction was stable.

Conclusion: In our selected patients, the proportion of acute stroke patients treated with systemic thrombolysis increased almost three-fold from 1998 to 2003. This may be explained by protocol modifications and growing experience with the use of rt-PA. Our data demonstrate that increased use of rt-PA in acute stroke patients can be achieved without adversely affecting safety or clinical benefit.