Is alteplase safe and effective in routine clinical practice for patients with ischemic stroke?
Alastair M Buchan* and Michael D Hill
Correspondence *Acute Stroke Programme, Nuffield Department of Medicine, University of Oxford, Level 7, John Radcliffe Hospital, Oxford OX3 9DU, UK
Email alastair.buchan@ndm.ox.ac.uk
This article has no abstract so we have provided the first paragraph of the full text.
Alteplase was approved for stroke thrombolysis in North America (US 1996, Canada 1999) well before it was licensed for this indication in Europe (2002). In North America, a condition of approval was the completion of a phase IV monitoring study of alteplase safety and effectiveness in routine clinical practice, which was subsequently confirmed by the STARS1 and CASES2 registries. Similar concerns from the EMEA led to SITS-MOST, the largest prospective, observational study of hyperacute thrombolytic stroke therapy published worldwide, which had outcomes similar to those in STARS and CASES, and at least as good as in RCTs.
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