Journal ArticleDOI
Thrombolysis with Alteplase 3 to 4.5 Hours After Acute Ischemic Stroke
Werner Hacke,Markku Kaste,Erich Bluhmki,Miroslav Brozman,Antoni Dávalos,Donata Guidetti,Vincent Larrue,Kennedy R. Lees,Zakaria Medeghri,Thomas Machnig,Dietmar Schneider,Rüdiger von Kummer,Nils Wahlgren,Danilo Toni +13 more
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TLDR
As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; altePlase was more frequently associated with symptomatic intracranial hemorrhage.Abstract:
Background Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke. Methods After exclusion of patients with a brain hemorrhage or major infarction, as detected on a computed tomographic scan, we randomly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase (0.9 mg per kilogram of body weight) or placebo. The primary end point was disability at 90 days, dichotomized as a favorable outcome (a score of 0 or 1 on the modified Rankin scale, which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) or an unfavorable outcome (a score of 2 to 6 on the modified Rankin scale). The secondary end point was a global outcome analysis of four neurologic and disability scores combined. Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events. Results We enrolled a total of 821 patients in the study and randomly assigned 418 to the alteplase group and 403 to the placebo group. The median time for the administration of alteplase was 3 hours 59 minutes. More patients had a favorable outcome with alte plase than with placebo (52.4% vs. 45.2%; odds ratio, 1.34; 95% confidence interval [CI], 1.02 to 1.76; P = 0.04). In the global analysis, the outcome was also improved with alteplase as compared with placebo (odds ratio, 1.28; 95% CI, 1.00 to 1.65; P<0.05). The incidence of intracranial hemorrhage was higher with alteplase than with placebo (for any intracranial hemorrhage, 27.0% vs. 17.6%; P = 0.001; for symptomatic intracranial hemorrhage, 2.4% vs. 0.2%; P = 0.008). Mortality did not differ significant ly between the alteplase and placebo groups (7.7% and 8.4%, respectively; P = 0.68). There was no significant difference in the rate of other serious adverse events. Conclusions As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; alteplase was more frequently associated with symptomatic intracranial hemorrhage. (ClinicalTrials.gov number, NCT00153036.)read more
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Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial.
Gregory W. Albers,Rüdiger von Kummer,Thomas Truelsen,Jens-Kristian Slott Jensen,Gabriela M Ravn,Bjørn A. Grønning,Hugues Chabriat,Ku-chou Chang,Antonio Dávalos,Gary A. Ford,James C. Grotta,Markku Kaste,Lee H. Schwamm,Ashfaq Shuaib +13 more
TL;DR: Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond 3 h of symptom onset.
Journal ArticleDOI
ACCESS: Acute Cerebrovascular Care in Emergency Stroke Systems
Karen C. Albright,Charles C. Branas,Brett C. Meyer,Dawn E. Matherne-Meyer,Justin A. Zivin,Patrick D. Lyden,Brendan G. Carr +6 more
TL;DR: The use of air ambulances to triage patients with ischemic stroke to a PSC would increase the percentage of the US population with prompt access to stroke care and have implications for the ongoing design of theUS stroke system.
Journal ArticleDOI
Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trial.
Ashfaq Shuaib,Natan M. Bornstein,Hans-Christoph Diener,William P. Dillon,Marc Fisher,Maxim D. Hammer,Carlos A. Molina,J. Neal Rutledge,Jeffrey L. Saver,Peter D. Schellinger,Harish Shownkeen +10 more
TL;DR: The trial met its primary safety end point but not its primary efficacy end point, and signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation.
Journal ArticleDOI
Finding an optimal rehabilitation paradigm after stroke: enhancing fiber growth and training of the brain at the right moment.
TL;DR: The mechanisms of spontaneous plasticity after stroke and experimental interventions to enhance growth and plasticity are summarized and potential future strategies for designing repair and rehabilitation paradigms are discussed by introducing a “3 step model”.
Journal ArticleDOI
A Review of the Mechanisms of Blood-Brain Barrier Permeability by Tissue-Type Plasminogen Activator Treatment for Cerebral Ischemia
TL;DR: It is reviewed the possibility that rt-PA increases the penetration of toxic molecules derived from the bloodstream including rT-PA itself, without disrupting the BBB, and contributes to these detrimental processes in the cerebral parenchyma.
References
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Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group.
James C. Grotta,M Kothari,K.M.A. Welch,Joseph P. Broderick,Barbara C. Tilley,Thomas G. Brott,Marler,Patrick D. Lyden,Paul M. O'Byrne +8 more
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ASSESSMENT OF OUTCOME AFTER SEVERE BRAIN DAMAGE: A Practical Scale
Bryan Jennett,Michael R. Bond +1 more
TL;DR: In this article, a five-point scale is described, which includes death, persistent vegetative state, severe disability, moderate disability, and good recovery, and duration as well as intensity of disability should be included in an index of ill-health.
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Interobserver agreement for the assessment of handicap in stroke patients.
TL;DR: The results confirm the value of the modified Rankin scale in the assessment of handicap in stroke patients; nevertheless, further improvements are possible.
Journal ArticleDOI
Measurements of acute cerebral infarction: a clinical examination scale.
Thomas Brott,Harold P. Adams,Charles P. Olinger,John R. Marler,William G. Barsan,José Biller,Judith Spilker,R Holleran,Robert Eberle,Vicki S. Hertzberg +9 more
TL;DR: A 15-item neurologic examination stroke scale for use in acute stroke therapy trials was designed and interrater reliability for the scale was found to be high, and test-retest reliability was also high, suggesting acceptable examination and scale validity.
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