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
A Computerized In-Hospital Alert System for Thrombolysis in Acute Stroke
Ji Hoe Heo,Young Dae Kim,Hyo Suk Nam,Keun-Sik Hong,Seong Hwan Ahn,Hyun Ji Cho,Hye Yeon Choi,Sang Won Han,Myoung Jin Cha,Jiman Hong,Gyeong Moon Kim,Gyu Sik Kim,Hye Jin Kim,Seo Hyun Kim,Yong-Jae Kim,Sun Uck Kwon,Byung-Chul Lee,Jun Hong Lee,Kwang-Ho Lee,Mi Sun Oh +19 more
TL;DR: In this article, the authors developed a stroke code program based on the computerized physician order entry (CPOE) system and investigated whether implementation of this CPOE-based program is useful for reducing the time from arrival at emergency departments (ED) to evaluation steps and the initiation of thrombolytic treatment in various hospital settings.
Journal ArticleDOI
Thrombolytic Therapy for Acute Stroke — Not a Moment to Lose
TL;DR: Thrombolytic therapy, which has stood the test of time, shown benefit in serial community registries on multiple continents, and received approval by every major regulatory authority in the world, is shown in a randomized, blinded, placebo-controlled trial to be efficacious.
Journal ArticleDOI
Can Diffusion-Weighted Imaging–Fluid-Attenuated Inversion Recovery Mismatch (Positive Diffusion-Weighted Imaging/Negative Fluid-Attenuated Inversion Recovery) at 3 Tesla Identify Patients With Stroke at <4.5 Hours?
TL;DR: This study improves the understanding of DWI–FLAIR mismatch as an imaging biomarker for wake-up management of patients with stroke by identifying patients within 4.5 hours of symptom onset.
Journal ArticleDOI
European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND:
H. Amiri,Erich Bluhmki,Martin Bendszus,Christoph C. Eschenfelder,Geoffrey A. Donnan,Didier Leys,Carlos A. Molina,Peter A. Ringleb,Peter D. Schellinger,Stefan Schwab,Danilo Toni,Nils Wahlgren,Werner Hacke +12 more
TL;DR: It is hypothesized that ischemic stroke patients selected with significant penumbral mismatch on magnetic resonance imaging (MRI) at 4.5–9 h after onset of stroke will have improved clinical outcomes when given intravenous rt-PA (alteplase) compared to placebo.
Journal ArticleDOI
tPA Helpers in the Treatment of Acute Ischemic Stroke: Are They Ready for Clinical Use?
TL;DR: A narrative review of drugs developed to interfere with various steps of ischemia/ reperfusion injuries or BBB destabilization, which successfully reduce infarct volume and decrease the incidence of ICH and HT after delayed tPA treatment in various animal stroke models.
References
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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
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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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