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Titolo:
RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF THROMBOLYTIC THERAPY WITH INTRAVENOUS ALTEPLASE IN ACUTE ISCHEMIC STROKE (ECASS-II)
Autore:
HACKE W; KASTE M; FIESCHI C; VONKUMMER R; DAVALOS A; MEIER D; LARRUE V; BLUHMKI E; DAVIS S; DONNAN G; SCHNEIDER D; DIEZTEJEDOR E; TROUILLAS P;
Indirizzi:
UNIV HEIDELBERG,SCH MED,DEPT NEUROL,NEUENHEIMER FELD 400 D-69120 HEIDELBERG GERMANY UNIV HELSINKI,DEPT NEUROL FIN-00014 HELSINKI FINLAND UNIV ROME,DEPT NEUROL ROME ITALY UNIV DRESDEN,DEPT NEURORADIOL DRESDEN GERMANY UNIV HOSP GIRONA,DEPT NEUROL GIRONA SPAIN BOEHRINGER INGELHEIM KG,DEPT CLIN RES INGELHEIM GERMANY BOEHRINGER INGELHEIM KG,DEPT STAT INGELHEIM GERMANY UNIV TOULOUSE,DEPT NEUROL TOULOUSE FRANCE UNIV MELBOURNE,DEPT NEUROL PARKVILLE VIC 3052 AUSTRALIA UNIV LEIPZIG,DEPT NEUROL LEIPZIG GERMANY UNIV MADRID,DEPT NEUROL MADRID SPAIN UNIV LYON,DEPT NEUROL LYON FRANCE
Titolo Testata:
Lancet
fascicolo: 9136, volume: 352, anno: 1998,
pagine: 1245 - 1251
SICI:
0140-6736(1998)352:9136<1245:RDPTOT>2.0.ZU;2-0
Fonte:
ISI
Lingua:
ENG
Soggetto:
ACUTE ISCHEMIC STROKE; TIME;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
19
Recensione:
Indirizzi per estratti:
Citazione:
W. Hacke et al., "RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF THROMBOLYTIC THERAPY WITH INTRAVENOUS ALTEPLASE IN ACUTE ISCHEMIC STROKE (ECASS-II)", Lancet, 352(9136), 1998, pp. 1245-1251

Abstract

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 (0.9 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 sincesymptom onset (0-3 h or 3-6 h). The primary endpoint was the modifiedRankin scale (mRS) at 90 days, dichotomised for favourable (score 0-1) and unfavourable (score 2-6) outcome. Analyses were by intention to treat. Findings 165 (40.3%) alteplase-group patients and 143 (36.6%) placebo-group patients had favourable mRS outcomes (absolute difference3.7%, p=0.277). In a post-hoc analysis of mRS scores dichotomised fardeath or dependency, 222 (54.3%) alteplase-group and 180 (46.0%) placebo-group patients had favourable outcomes (score 0-2; absolute difference 8.3%, p=0.024). Treatment differences were similar whether patients were treated within 3 h or 3-6 h, 85 (10.6%) patients died, with nodifference between treatment groups at day 90+/-14 days (43 alteplase, 42 placebo). Symptomatic intracranial haemorrhage occurred in 36 (8.8%) alteplase-group patients and 13 (3.4%) 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 ui evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at adose of 0.9 mg/kg in selected patients may lead to a clinically relevant improvement in outcome.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 02/12/20 alle ore 05:22:27