Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II)
Identifieur interne : 00C888 ( Main/Exploration ); précédent : 00C887; suivant : 00C889Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II)
Auteurs : Werner Hacke [Allemagne] ; Markku Kaste [Finlande] ; Cesare Fieschi [Italie] ; Rdiger Von Kummer [Allemagne] ; Antoni Davalos [Espagne] ; Dieter Meier [Allemagne] ; Vincent Larrue [France] ; Erich Bluhmki [Allemagne] ; Stephen Davis [Australie] ; Geoffrey Donnan [Australie] ; Dietmar Schneider [Allemagne] ; Exuperio Diez-Tejedor [Espagne] ; Paul Trouillas [France]Source :
- The Lancet [ 0140-6736 ] ; 1998.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme, Neurologie.
English descriptors
- KwdEn :
- Absolute difference, Acute, Acute ischaemic stroke, Adverse events, Alteplase, Alteplase group, Alteplase placebo, Baseline, Boehringer ingelheim, Controlled therapeutic trial, Dieter meier, Ecass, Endpoint, Evaluation, Exact test, Favourable, Favourable outcome, Further endpoints, Hacke, Haemorrhage, Haemorrhagic, Haemorrhagic infarction, Human, Infarcted area, Infarction, Intracranial, Intracranial haemorrhage, Intracranial haemorrhages, Intravenous, Intravenous administration, Ischaemic, Ischemia, Kaste, Kummer, Lancet, Lower dose, Median, Median change, More deaths, More patients, National institute, Neurological, Neurological disorders, Neurology, Nihss, Ninds, Ninds trial, October, Parenchymal, Parenchymal haemorrhage, Placebo, Placebo group, Placebo groups, Previous trials, Primary endpoint, Randomised, Randomised patients, Randomization, Reading panel, Risk factor, Significant difference, Significant differences, Stroke, Stroke onset, Symptom onset, Symptomatic intracranial haemorrhage, Thrombolysis, Thrombolytic, Thrombolytic therapy, Treatment efficiency, Treatment groups, Wilcoxon test.
- Teeft :
- Absolute difference, Acute ischaemic stroke, Adverse events, Alteplase, Alteplase group, Alteplase placebo, Baseline, Boehringer ingelheim, Dieter meier, Ecass, Endpoint, Exact test, Favourable, Favourable outcome, Further endpoints, Hacke, Haemorrhage, Haemorrhagic, Haemorrhagic infarction, Infarcted area, Infarction, Intracranial, Intracranial haemorrhage, Intracranial haemorrhages, Intravenous, Ischaemic, Kaste, Kummer, Lancet, Lower dose, Median, Median change, More deaths, More patients, National institute, Neurological, Neurological disorders, Neurology, Nihss, Ninds, Ninds trial, October, Parenchymal, Parenchymal haemorrhage, Placebo, Placebo group, Placebo groups, Previous trials, Primary endpoint, Randomised, Randomised patients, Reading panel, Significant difference, Significant differences, Stroke onset, Symptom onset, Symptomatic intracranial haemorrhage, Thrombolysis, Thrombolytic, Thrombolytic therapy, Treatment groups, Wilcoxon test.
Abstract
Summary: Background Thrombolysis for acute ischaemic stroke has been investigated in several clinical trials, with variable results. We have assessed the safety and efficacy of intravenous thrombolysis with alteplase (09 mg/kg bodyweight) within 6 h of stroke onset.Methods This non-angiographic, randomised, double-blind, trial enrolled 800 patients in Europe, Australia, and New Zealand. Computed tomography was used to exclude patients with signs of major infarction. Alteplase (n=409) and placebo (n=391) were randomly assigned with stratification for time since symptom onset (03 h or 36 h). The primary endpoint was the modified Rankin scale (mRS) at 90 days, dichotomised for favourable (score 01) and unfavourable (score 26) outcome. Analyses were by intention to treat.Findings 165 (403) alteplase-group patients and 143 (366) placebo-group patients had favourable mRS outcomes (absolute difference 37, p=0277). In a post-hoc analysis of mRS scores dichotomised for death or dependency, 222 (543) alteplase-group and 180 (460) placebo-group patients had favourable outcomes (score 02; absolute difference 83, p=0024). Treatment differences were similar whether patients were treated within 3 h or 36 h. 85 (106) patients died, with no difference between treatment groups at day 9014 days (43 alteplase, 42 placebo). Symptomatic intracranial haemorrhage occurred in 36 (88) alteplase-group patients and 13 (34) placebo-group patients.Interpretation The results do not confirm a statistical benefit for alteplase. However, we believe the trend towards efficacy should be interpreted in the light of evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at a dose of 09 mg/kg in selected patients may lead to a clinically relevant improvement in outcome.
Url:
DOI: 10.1016/S0140-6736(98)08020-9
Affiliations:
- Allemagne, Australie, Espagne, Finlande, France, Italie
- Uusimaa, Victoria (État)
- Helsinki, Melbourne
- Université d'Helsinki, Université de Melbourne
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wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University of Heidelberg</wicri:regionArea><wicri:noRegion>University of Heidelberg</wicri:noRegion><wicri:noRegion>University of Heidelberg</wicri:noRegion></affiliation></author><author><name sortKey="Kaste, Markku" sort="Kaste, Markku" uniqKey="Kaste M" first="Markku" last="Kaste">Markku Kaste</name><affiliation wicri:level="4"><country xml:lang="fr">Finlande</country><wicri:regionArea>Department of Neurology, University of Helsinki</wicri:regionArea><placeName><settlement type="city">Helsinki</settlement><region type="région" nuts="2">Uusimaa</region></placeName><orgName type="university">Université d'Helsinki</orgName></affiliation></author><author><name sortKey="Fieschi, Cesare" sort="Fieschi, Cesare" uniqKey="Fieschi C" first="Cesare" last="Fieschi">Cesare Fieschi</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, University of Rome</wicri:regionArea><wicri:noRegion>University of Rome</wicri:noRegion></affiliation></author><author><name sortKey="Von Kummer, Rdiger" sort="Von Kummer, Rdiger" uniqKey="Von Kummer R" first="Rdiger" last="Von Kummer">Rdiger Von Kummer</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neuroradiology, University of Dresden</wicri:regionArea><wicri:noRegion>University of Dresden</wicri:noRegion><wicri:noRegion>University of Dresden</wicri:noRegion></affiliation></author><author><name sortKey="Davalos, Antoni" sort="Davalos, Antoni" uniqKey="Davalos A" first="Antoni" last="Davalos">Antoni Davalos</name><affiliation wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Neurology, University Hospital of Girona</wicri:regionArea><wicri:noRegion>University Hospital of Girona</wicri:noRegion></affiliation></author><author><name sortKey="Meier, Dieter" sort="Meier, Dieter" uniqKey="Meier D" first="Dieter" last="Meier">Dieter Meier</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Research, Boehringer Ingelheim</wicri:regionArea><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion></affiliation></author><author><name sortKey="Larrue, Vincent" sort="Larrue, Vincent" uniqKey="Larrue V" first="Vincent" last="Larrue">Vincent Larrue</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurology, University of Toulouse</wicri:regionArea><wicri:noRegion>University of Toulouse</wicri:noRegion><wicri:noRegion>University of Toulouse</wicri:noRegion></affiliation></author><author><name sortKey="Bluhmki, Erich" sort="Bluhmki, Erich" uniqKey="Bluhmki E" first="Erich" last="Bluhmki">Erich Bluhmki</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Statistics, Boehringer Ingelheim</wicri:regionArea><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion></affiliation></author><author><name sortKey="Davis, Stephen" sort="Davis, Stephen" uniqKey="Davis S" first="Stephen" last="Davis">Stephen Davis</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Neurology, University of Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Donnan, Geoffrey" sort="Donnan, Geoffrey" uniqKey="Donnan G" first="Geoffrey" last="Donnan">Geoffrey Donnan</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Neurology, University of Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Schneider, Dietmar" sort="Schneider, Dietmar" uniqKey="Schneider D" first="Dietmar" last="Schneider">Dietmar Schneider</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University of Leipzig</wicri:regionArea><wicri:noRegion>University of Leipzig</wicri:noRegion><wicri:noRegion>University of Leipzig</wicri:noRegion></affiliation></author><author><name sortKey="Diez Tejedor, Exuperio" sort="Diez Tejedor, Exuperio" uniqKey="Diez Tejedor E" first="Exuperio" last="Diez-Tejedor">Exuperio Diez-Tejedor</name><affiliation wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Neurology, University of Madrid</wicri:regionArea><wicri:noRegion>University of Madrid</wicri:noRegion></affiliation></author><author><name sortKey="Trouillas, Paul" sort="Trouillas, Paul" uniqKey="Trouillas P" first="Paul" last="Trouillas">Paul Trouillas</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurology, University of Lyon</wicri:regionArea><wicri:noRegion>University of Lyon</wicri:noRegion><wicri:noRegion>University of Lyon</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">The Lancet</title><title level="j" type="abbrev">LANCET</title><idno type="ISSN">0140-6736</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1998">1998</date><biblScope unit="volume">352</biblScope><biblScope unit="issue">9136</biblScope><biblScope unit="page" from="1238">1238</biblScope><biblScope unit="page" to="1239">1239</biblScope></imprint><idno type="ISSN">0140-6736</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Absolute difference</term><term>Acute</term><term>Acute ischaemic stroke</term><term>Adverse events</term><term>Alteplase</term><term>Alteplase group</term><term>Alteplase placebo</term><term>Baseline</term><term>Boehringer ingelheim</term><term>Controlled therapeutic trial</term><term>Dieter meier</term><term>Ecass</term><term>Endpoint</term><term>Evaluation</term><term>Exact test</term><term>Favourable</term><term>Favourable outcome</term><term>Further endpoints</term><term>Hacke</term><term>Haemorrhage</term><term>Haemorrhagic</term><term>Haemorrhagic infarction</term><term>Human</term><term>Infarcted area</term><term>Infarction</term><term>Intracranial</term><term>Intracranial haemorrhage</term><term>Intracranial haemorrhages</term><term>Intravenous</term><term>Intravenous administration</term><term>Ischaemic</term><term>Ischemia</term><term>Kaste</term><term>Kummer</term><term>Lancet</term><term>Lower dose</term><term>Median</term><term>Median change</term><term>More deaths</term><term>More patients</term><term>National institute</term><term>Neurological</term><term>Neurological disorders</term><term>Neurology</term><term>Nihss</term><term>Ninds</term><term>Ninds trial</term><term>October</term><term>Parenchymal</term><term>Parenchymal haemorrhage</term><term>Placebo</term><term>Placebo group</term><term>Placebo groups</term><term>Previous trials</term><term>Primary endpoint</term><term>Randomised</term><term>Randomised patients</term><term>Randomization</term><term>Reading panel</term><term>Risk factor</term><term>Significant difference</term><term>Significant differences</term><term>Stroke</term><term>Stroke onset</term><term>Symptom onset</term><term>Symptomatic intracranial haemorrhage</term><term>Thrombolysis</term><term>Thrombolytic</term><term>Thrombolytic therapy</term><term>Treatment efficiency</term><term>Treatment groups</term><term>Wilcoxon test</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Accident cérébrovasculaire</term><term>Aigu</term><term>Altéplase</term><term>Efficacité traitement</term><term>Essai thérapeutique contrôlé</term><term>Evaluation</term><term>Facteur risque</term><term>Homme</term><term>Ischémie</term><term>Placebo</term><term>Randomisation</term><term>Voie intraveineuse</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Absolute difference</term><term>Acute ischaemic stroke</term><term>Adverse events</term><term>Alteplase</term><term>Alteplase group</term><term>Alteplase placebo</term><term>Baseline</term><term>Boehringer ingelheim</term><term>Dieter meier</term><term>Ecass</term><term>Endpoint</term><term>Exact test</term><term>Favourable</term><term>Favourable outcome</term><term>Further endpoints</term><term>Hacke</term><term>Haemorrhage</term><term>Haemorrhagic</term><term>Haemorrhagic infarction</term><term>Infarcted area</term><term>Infarction</term><term>Intracranial</term><term>Intracranial haemorrhage</term><term>Intracranial haemorrhages</term><term>Intravenous</term><term>Ischaemic</term><term>Kaste</term><term>Kummer</term><term>Lancet</term><term>Lower dose</term><term>Median</term><term>Median change</term><term>More deaths</term><term>More patients</term><term>National institute</term><term>Neurological</term><term>Neurological disorders</term><term>Neurology</term><term>Nihss</term><term>Ninds</term><term>Ninds trial</term><term>October</term><term>Parenchymal</term><term>Parenchymal haemorrhage</term><term>Placebo</term><term>Placebo group</term><term>Placebo groups</term><term>Previous trials</term><term>Primary endpoint</term><term>Randomised</term><term>Randomised patients</term><term>Reading panel</term><term>Significant difference</term><term>Significant differences</term><term>Stroke onset</term><term>Symptom onset</term><term>Symptomatic intracranial haemorrhage</term><term>Thrombolysis</term><term>Thrombolytic</term><term>Thrombolytic therapy</term><term>Treatment groups</term><term>Wilcoxon test</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Neurologie</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Summary: Background Thrombolysis for acute ischaemic stroke has been investigated in several clinical trials, with variable results. We have assessed the safety and efficacy of intravenous thrombolysis with alteplase (09 mg/kg bodyweight) within 6 h of stroke onset.Methods This non-angiographic, randomised, double-blind, trial enrolled 800 patients in Europe, Australia, and New Zealand. Computed tomography was used to exclude patients with signs of major infarction. Alteplase (n=409) and placebo (n=391) were randomly assigned with stratification for time since symptom onset (03 h or 36 h). The primary endpoint was the modified Rankin scale (mRS) at 90 days, dichotomised for favourable (score 01) and unfavourable (score 26) outcome. Analyses were by intention to treat.Findings 165 (403) alteplase-group patients and 143 (366) placebo-group patients had favourable mRS outcomes (absolute difference 37, p=0277). In a post-hoc analysis of mRS scores dichotomised for death or dependency, 222 (543) alteplase-group and 180 (460) placebo-group patients had favourable outcomes (score 02; absolute difference 83, p=0024). Treatment differences were similar whether patients were treated within 3 h or 36 h. 85 (106) patients died, with no difference between treatment groups at day 9014 days (43 alteplase, 42 placebo). Symptomatic intracranial haemorrhage occurred in 36 (88) alteplase-group patients and 13 (34) placebo-group patients.Interpretation The results do not confirm a statistical benefit for alteplase. However, we believe the trend towards efficacy should be interpreted in the light of evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at a dose of 09 mg/kg in selected patients may lead to a clinically relevant improvement in outcome.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Espagne</li><li>Finlande</li><li>France</li><li>Italie</li></country><region><li>Uusimaa</li><li>Victoria (État)</li></region><settlement><li>Helsinki</li><li>Melbourne</li></settlement><orgName><li>Université d'Helsinki</li><li>Université de Melbourne</li></orgName></list><tree><country name="Allemagne"><noRegion><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name></noRegion><name sortKey="Bluhmki, Erich" sort="Bluhmki, Erich" uniqKey="Bluhmki E" first="Erich" last="Bluhmki">Erich Bluhmki</name><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name><name sortKey="Meier, Dieter" sort="Meier, Dieter" uniqKey="Meier D" first="Dieter" last="Meier">Dieter Meier</name><name sortKey="Schneider, Dietmar" sort="Schneider, Dietmar" uniqKey="Schneider D" first="Dietmar" last="Schneider">Dietmar Schneider</name><name sortKey="Von Kummer, Rdiger" sort="Von Kummer, Rdiger" uniqKey="Von Kummer R" first="Rdiger" last="Von Kummer">Rdiger Von Kummer</name></country><country name="Finlande"><region name="Uusimaa"><name sortKey="Kaste, Markku" sort="Kaste, Markku" uniqKey="Kaste M" first="Markku" last="Kaste">Markku Kaste</name></region></country><country name="Italie"><noRegion><name sortKey="Fieschi, Cesare" sort="Fieschi, Cesare" uniqKey="Fieschi C" first="Cesare" last="Fieschi">Cesare Fieschi</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Davalos, Antoni" sort="Davalos, Antoni" uniqKey="Davalos A" first="Antoni" last="Davalos">Antoni Davalos</name></noRegion><name sortKey="Diez Tejedor, Exuperio" sort="Diez Tejedor, Exuperio" uniqKey="Diez Tejedor E" first="Exuperio" last="Diez-Tejedor">Exuperio Diez-Tejedor</name></country><country name="France"><noRegion><name sortKey="Larrue, Vincent" sort="Larrue, Vincent" uniqKey="Larrue V" first="Vincent" last="Larrue">Vincent Larrue</name></noRegion><name sortKey="Trouillas, Paul" sort="Trouillas, Paul" uniqKey="Trouillas P" first="Paul" last="Trouillas">Paul Trouillas</name></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Davis, Stephen" sort="Davis, Stephen" uniqKey="Davis S" first="Stephen" last="Davis">Stephen Davis</name></region><name sortKey="Donnan, Geoffrey" sort="Donnan, Geoffrey" uniqKey="Donnan G" first="Geoffrey" last="Donnan">Geoffrey Donnan</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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