Authors' objectives:

This study aims to assess the effectiveness of thrombolysis with plasminogen activator (rtPA) in stroke.

Authors' results and conclusions: Eight randomized controlled studies involving 2,955 patients have been conducted where treatment with rtPA was initiated within 6 hours following onset. The most serious risk of treatment is the risk for cerebral hemorrhage. An increase in symptomatic (including fatal) cerebral hemorrhage has been found in 62 of 1,000 patients treated. Nevertheless, a net gain in overall outcome has been shown, namely that an additional 55 of 1 000 patients survived or were not dependent of the help of others if they were treated with rtPA. The highest percentage of positive effects was found in the 957 patients where treatment was initiated within the first 3 hours following onset. Of these, 110 of 1,000 patients treated avoided death or dependency on others.

Authors' recommendations: Thrombolysis with rtPA within 3 hours of onset in patients up to 80 years of age yields a generally positive result (Evidence grade 2) despite the increase in severe brain hemorrhages (Evidence grade 1). Relatively few patients were included in the studies, and the studies were conducted at specialized centers. Therefore, it is important to follow up the results in general health services by using quality registries (SITS-MOST, Riks-Stroke). Effect size and risk must also be presented with greater precision. Sweden needs to participate in large international randomized trials to acquire further knowledge about which patients benefit, eg, regarding age and longer time periods following onset, and which patients are at higher risk. Knowledge concerning cost effectiveness is greatly limited (Evidence grade 4), and further studies are needed.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.sbu.se/Published

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Sweden

Organisation Name: Swedish Agency for Health Technology Assessment and Assessment of Social Services

Contact Address: P.O. Box 3657, SE-103 59 Stockholm, Sweden. Tel: +46 8 4123200, Fax: +46 8 4113260

Contact Name: registrator@sbu.se

Contact Email: registrator@sbu.se

Copyright: Swedish Council on Technology Assessment in Health Care (SBU)