Key result
German rt-PA approval linked to an absolute ~3% increase in thrombolysis for acute ischemic stroke.
Observational (n=6,129)
Yes
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BACKGROUND: Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) within 3 h after onset of focal cerebral ischemia was approved in Germany in August 2000. METHODS: 11 neurology departments with acute stroke units participated in the German Stroke Study Collaboration before (n = 2,925) and after (n = 3,204) approval of rt-PA in Germany and consecutively registered all patients admitted within 24 h following acute ischemic stroke. RESULTS: Frequency of intravenous thrombolysis in patients admitted within 24 h after symptom onset increased from 4.8% before approval to 7.9% after approval of rt-PA. Among patients treated with rtPA, age increased significantly and the delay between symptom onset and imaging was significantly shorter in the second study period. CONCLUSIONS: The observed improvement in management and quantity of intravenous thrombolysis may be explained by greater experience and greater legal security following regulatory approval of rtPA.
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Weimar et al. (2006) conducted an observational in Acute ischemic stroke (n=6,129). Post-regulatory approval period of recombinant tissue plasminogen activator (rt-PA) vs. Pre-regulatory approval period of rt-PA was evaluated on Frequency of intravenous thrombolysis with rt-PA in patients admitted within 24 h after symptom onset. Regulatory approval of rt-PA in Germany was associated with an increase in intravenous thrombolysis frequency from 4.8% to 7.9% among acute ischemic stroke admissions.
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