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A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke
- Source :
- New England Journal of Medicine, 385(20), 1833-1844. MASSACHUSETTS MEDICAL SOCIETY, New England Journal of Medicine, 385(20), 1833-1844. Massachussetts Medical Society, The New England Journal of Medicine, 385, 20, pp. 1833-1844, New England journal of medicine, 385(20), 1833-1844. Massachussetts Medical Society, The New England Journal of Medicine, 385, 1833-1844, New England Journal of Medicine, 385(20), 1833-1844. MASSACHUSETTS MEDICAL SOC
- Publication Year :
- 2021
-
Abstract
- Alteplase with EVT versus EVT Alone for Stroke Trials involving Asian patients with acute stroke have suggested that endovascular treatment alone is not inferior to the usual practice of thrombolysis before endovascular treatment. This trial involving European patients did not show noninferiority or superiority of endovascular treatment alone.Background The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations. Methods We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points. Results The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P=0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81). Conclusions In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, .)
- Subjects :
- Male
Infusions
medicine.medical_specialty
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
MEDLINE
GUIDELINES
Severity of Illness Index
THERAPY
law.invention
Tissue Plasminogen Activator/therapeutic use
All institutes and research themes of the Radboud University Medical Center
Fibrinolytic Agents
Randomized controlled trial
law
80 and over
medicine
Humans
cardiovascular diseases
ACUTE ISCHEMIC-STROKE
Endovascular treatment
Infusions, Intravenous
Acute ischemic stroke
Stroke
Ischemic Stroke
Aged
Thrombectomy
Aged, 80 and over
THROMBOLYSIS
business.industry
Fibrinolytic Agents/therapeutic use
MECHANICAL THROMBECTOMY
Endovascular Procedures
Other Research Radboud Institute for Health Sciences [Radboudumc 0]
General Medicine
Middle Aged
CARE
medicine.disease
Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3]
Combined Modality Therapy
Europe
Treatment Outcome
Tissue Plasminogen Activator
Emergency medicine
Female
Ischemic Stroke/drug therapy
Intravenous
business
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine, 385(20), 1833-1844. MASSACHUSETTS MEDICAL SOCIETY, New England Journal of Medicine, 385(20), 1833-1844. Massachussetts Medical Society, The New England Journal of Medicine, 385, 20, pp. 1833-1844, New England journal of medicine, 385(20), 1833-1844. Massachussetts Medical Society, The New England Journal of Medicine, 385, 1833-1844, New England Journal of Medicine, 385(20), 1833-1844. MASSACHUSETTS MEDICAL SOC
- Accession number :
- edsair.doi.dedup.....ead65362d4c45b9e8129923770b49aea