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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Journal ArticleDOI
Systematic review of mass media interventions designed to improve public recognition of stroke symptoms, emergency response and early treatment.
TL;DR: One campaign targeted at public and professionals did not reduce time to presentation at hospital to within two hours, but increased and sustained thrombolysis rates, which suggests the campaign had a primary impact on professionals and improved the way that services for stroke were organised.
Journal ArticleDOI
Risks of Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Receiving Warfarin and Treated With Intravenous Tissue Plasminogen Activator
Ying Xian,Li Liang,Eric E. Smith,Lee H. Schwamm,Mathew J. Reeves,DaiWai M. Olson,Adrian F. Hernandez,Gregg C. Fonarow,Eric D. Peterson +8 more
TL;DR: Among patients with ischemic stroke, the use of intravenous tPA among warfarin-treated patients (INR ≤1.7) was not associated with increased sICH risk compared with non-warfarin -treated patients, and the degree of anticoagulation was not statistically significantly associated.
Journal ArticleDOI
Safety of Thrombolysis in Stroke Mimics Results From a Multicenter Cohort Study
Sanne M. Zinkstok,Stefan T. Engelter,Henrik Gensicke,Philippe Lyrer,Peter A. Ringleb,Ville Artto,Jukka Putaala,Elena Haapaniemi,Turgut Tatlisumak,Yaohua Chen,Didier Leys,Hakan Sarikaya,Patrik Michel,Céline Odier,Jörg Berrouschot,Marcel Arnold,Mirjam Rachel Heldner,Andrea Zini,Valentina Fioravanti,Visnja Padjen,Ljiljana Beslac-Bumbasirevic,Alessandro Pezzini,Yvo B.W.E.M. Roos,Paul J. Nederkoorn +23 more
TL;DR: In experienced stroke centers, among patients treated with intravenous thrombolysis, only a few had a final diagnosis other than stroke, and the complication rate in these stroke mimics was low.
Journal ArticleDOI
Why are acute ischemic stroke patients not receiving IV tPA? Results from a national registry
Steven R. Messé,Pooja Khatri,Mathew J. Reeves,Eric E. Smith,Jeffrey L. Saver,Deepak L. Bhatt,Maria V. Grau-Sepulveda,Margueritte Cox,Eric D. Peterson,Gregg C. Fonarow,Lee H. Schwamm +10 more
TL;DR: Overall, about one-quarter of eligible patients with AIS presenting within 2 hours of stroke onset failed to receive tPA treatment, indicating thrombolysis has improved dramatically over time and is strongly associated with stroke center certification.
Journal ArticleDOI
Transfer Delay Is a Major Factor Limiting the Use of Intra-Arterial Treatment in Acute Ischemic Stroke
Shyam Prabhakaran,Edward Ward,Sayona John,Demetrius K. Lopes,Michael Chen,Richard E. Temes,Yousef Mohammad,Vivien H. Lee,Thomas P. Bleck +8 more
TL;DR: The likelihood of receiving IAT decreases rapidly by increasing transfer time, and specific goals for transfer time should be considered in future quality standards for hub-and-spoke–organized stroke networks.
References
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Journal ArticleDOI
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
Journal ArticleDOI
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.
Journal ArticleDOI
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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