Title: ECASS-II: intravenous alteplase in acute ischaemic stroke
Abstract: The publication of the European Co-operative Acute Stroke Study-II (ECASS-II) (Oct 17, p 1245)1Hacke W Kaste M Fieschi C et al.Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II).Lancet. 1998; 352: 1245-1251Summary Full Text Full Text PDF PubMed Scopus (3060) Google Scholar increases the data on the use of alteplase in acute stroke. In an accompanying commentary, Philip Bath2Bath P Alteplase not yet proven for acute ischaemic stroke.Lancet. 1998; 352: 1238-1239Summary Full Text Full Text PDF PubMed Scopus (31) Google Scholar concludes that the case for alteplase in acute ischaemic stroke is not yet proven. Although this conclusion is true for treatment within the 3-6 h window, examination of the combined data does not support it for appropriately selected patients treated within 3 h. ECASS-I3Steiner T Bluhmki E Kaste M et al.The ECASS 3-hour cohort: secondary analysis of ECASS data by time stratification.Cerebrovasc Dis. 1998; 8: 198-203Crossref PubMed Scopus (127) Google Scholar and ECASS-II together contained only 245 patients who received treatment before 3 h. By contrast, NINDS included 612 patients, all of whom received treatment in this time window.4The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study GroupTissue plasminogen activator for acute ischemic stroke.N Engl J Med. 1995; 333: 1581-1587Crossref PubMed Scopus (10446) Google Scholar The figure shows the odds ratio for each trial and a fixed effects pooled overall estimate for favourable outcome (modified Rankin Score of ≤2). Rather than undermine the positive results from NINDS,4The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study GroupTissue plasminogen activator for acute ischemic stroke.N Engl J Med. 1995; 333: 1581-1587Crossref PubMed Scopus (10446) Google Scholar ECASS-II provides further limited support for the conclusion that alteplase improves functional outcome in selected patients treated within 3 h of symptom onset. Factors other than time window may account for differences between the NINDS and ECASS study results. Bath notes that the condition of patients included in NINDS was more severe, and less likely to have a favourable outcome. He rightly comments that worthwhile benefits may only be seen in patients similar to those included in NINDS. A further confounding factor could be differences in care, other than randomised treatment, that may challenge the interpretation of the results. Organised rehabilitation care has a substantial impact on outcomes in stroke at 3 months. Any differences in rehabilitation care provided to patients in NINDS to ECASS study centres could either enhance or reduce any therapeutic benefit of alteplase over placebo. This was seen for acute myocardial infarction in the GUSTO trial, where substantial differences were observed between patients treated in the USA and other countries.5Van de Werf F Topol EJ Lee KL et al.Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries: results from the GUSTO trial.JAMA. 1995; 273: 1586-1591Crossref PubMed Scopus (144) Google Scholar With the enormous cost associated with disability resulting from stroke, even modest sustained benefits in functional status, such as 3-5% reduction in death and dependency, may be costeffective. Further trials, focusing on the 3-6 h window, are needed. These should incorporate longer follow-up periods and relevant economic outcomes. Any future study should also include patients aged over 80 years, who were excluded from ECASS but constitute an increasing proportion of the stroke population. Older patients have a very high risk of poor outcome and may have greater absolute benefits from thrombolysis despite any possible increased risk of symptomatic haemorrhage. Gary Ford was an investigator in ECASS-II, and has received fees and expenses from Boehringer Ingelheim. ECASS-II: intravenous alteplase in acute ischaemic strokeAuthors' reply Full-Text PDF
Publication Year: 1999
Publication Date: 1999-01-01
Language: en
Type: letter
Indexed In: ['crossref', 'pubmed']
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Cited By Count: 42
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