Extending the time window for intravenous thrombolysis in acute ischemic stroke using magnetic resonance imaging-based patient selection.

Authors:
Peter Ringleb
Peter Ringleb
University of Heidelberg
Germany
Martin Bendszus
Martin Bendszus
University of Heidelberg
Germany
Erich Bluhmki
Erich Bluhmki
University of Glasgow
United Kingdom
Geoffrey Donnan
Geoffrey Donnan
Florey Institute of Neuroscience and Mental Health
Australia
Christoph Eschenfelder
Christoph Eschenfelder
Zhejiang University
China
Marc Fatar
Marc Fatar
University of Heidelberg
Germany
Christof Kessler
Christof Kessler
University of Greifswald
Germany
Carlos Molina
Carlos Molina
Hospital Vall d'Hebron
Barcelona | Spain

Int J Stroke 2019 Apr 4:1747493019840938. Epub 2019 Apr 4.

16 Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany.

Background: Intravenous thrombolysis with alteplase within a time window up to 4.5 h is the only approved pharmacological treatment for acute ischemic stroke. We studied whether acute ischemic stroke patients with penumbral tissue identified on magnetic resonance imaging 4.5-9 h after symptom onset benefit from intravenous thrombolysis compared to placebo.

Methods: Acute ischemic stroke patients with salvageable brain tissue identified on a magnetic resonance imaging were randomly assigned to receive standard dose alteplase or placebo. The primary end point was disability at 90 days assessed by the modified Rankin scale, which has a range of 0-6 (with 0 indicating no symptoms at all and 6 indicating death). Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events.

Results: The trial was stopped early for slow recruitment after the enrollment of 119 (61 alteplase, 58 placebo) of 264 patients planned. Median time to intravenous thrombolysis was 7 h 42 min. The primary endpoint showed no significant difference in the modified Rankin scale distribution at day 90 (odds ratio alteplase versus placebo, 1.20; 95% CI, 0.63-2.27, P = 0.58). One symptomatic intracranial hemorrhage occurred in the alteplase group. Mortality at 90 days did not differ significantly between the two groups (11.5 and 6.8%, respectively; P = 0.53).

Conclusions: Intravenous alteplase administered between 4.5 and 9 h after the onset of symptoms in patients with salvageable tissue did not result in a significant benefit over placebo. (Supported by Boehringer Ingelheim, Germany; ISRCTN 71616222).

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http://dx.doi.org/10.1177/1747493019840938DOI Listing
April 2019
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