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
Reads0
Chats0
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
Citations
More filters
Journal ArticleDOI
Guidelines for the Early Management of Patients With Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association
William J. Powers,Alejandro A. Rabinstein,Teri Ackerson,Opeolu Adeoye,Nicholas C. Bambakidis,Kyra J. Becker,José Biller,Michael D. Brown,Bart M. Demaerschalk,Brian L. Hoh,Edward C. Jauch,Chelsea S. Kidwell,Thabele M Leslie-Mazwi,Bruce Ovbiagele,Phillip A. Scott,Kevin N. Sheth,Andrew M. Southerland,Deborah V. Summers,David L. Tirschwell +18 more
TL;DR: These guidelines supersede the prior 2007 guidelines and 2009 updates and support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit.
Journal ArticleDOI
A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
Debbie Beumer,Debbie Beumer,Julie Staals,Jeannette Hofmeijer,Jelis Boiten,J. De Vries,Omid S. Eshghi,Koos Keizer,R. van den Berg,A. van der Lugt,Abstr Act +10 more
TL;DR: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe.
Journal ArticleDOI
2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
Paul K. Whelton,Robert M. Carey,Wilbert S. Aronow,Donald E. Casey,Karen J. Collins,Cheryl Dennison Himmelfarb,Sondra M. DePalma,Samuel S. Gidding,Kenneth Jamerson,Daniel W. Jones,Eric J. MacLaughlin,Paul Muntner,Bruce Ovbiagele,Sidney C. Smith,Crystal C. Spencer,Randall S. Stafford,Sandra J. Taler,Randal J. Thomas,Kim A. Williams,Jeff D. Williamson,Jackson T. Wright +20 more
TL;DR: Since 1980, the American College of Cardiology and American Heart Association have translated scientific evidence into clinical practice guidelines (guidelines) with recommendations to improve cardiovascular health.
Journal ArticleDOI
Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke
Jeffrey L. Saver,Mayank Goyal,Alain Bonafe,Hans-Christoph Diener,Elad I. Levy,Vitor Mendes Pereira,Gregory W. Albers,Christophe Cognard,David J. Cohen,Werner Hacke,Olav Jansen,Tudor G Jovin,Heinrich Mattle,Raul G Nogueira,Adnan H. Siddiqui,Dileep R. Yavagal,Blaise Baxter,Thomas Devlin,Demetrius K. Lopes,Vivek Y. Reddy,Richard du Mesnil de Rochemont,Oliver C. Singer,Reza Jahan +22 more
TL;DR: In patients receiving intravenous t-PA for acute ischemic stroke, thrombectomy with the use of a stent retriever within 6 hours after onset improved functional outcomes at 90 days.
Journal ArticleDOI
Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.
William J. Powers,Alejandro A. Rabinstein,Teri Ackerson,Opeolu Adeoye,Nicholas C. Bambakidis,Kyra J. Becker,José Biller,Michael D. Brown,Bart M. Demaerschalk,Brian L. Hoh,Edward C. Jauch,Chelsea S. Kidwell,Thabele M Leslie-Mazwi,Bruce Ovbiagele,Phillip A. Scott,Kevin N. Sheth,Andrew M. Southerland,Deborah V. Summers,David L. Tirschwell +18 more
TL;DR: These guidelines detail prehospital care, urgent and emergency evaluation and treatment with intravenous and intra-arterial therapies, and in-hospital management, including secondary prevention measures that are appropriately instituted within the first 2 weeks.
References
More filters
Journal ArticleDOI
Symptomatic Intracerebral Hemorrhage following Thrombolytic Therapy for Acute Ischemic Stroke: A Review of the Risk Factors
TL;DR: Data from this systematic review should not alter the current guidelines for the use of rt-PA in acute stroke, but may help develop future strategies aimed at reducing the rate of thrombolysis-associated SICH.
Journal ArticleDOI
Shift Analysis Versus Dichotomization of the Modified Rankin Scale Outcome Scores in the NINDS and ECASS-II Trials
TL;DR: Tissue plasminogen activator causes a beneficial shift toward wellness on the mRS in both the NINDS and ECASS-II trials, but the shift effect is not global for all treated patients and does not outperform the dichotomized 0 to 2 outcome.
Journal ArticleDOI
Initial Experience of a Digital Training Resource for Modified Rankin Scale Assessment in Clinical Trials
TL;DR: Certification results suggest that use of the mRS training resource can improve mRS grading, and outline the development of a video-based training package, including technical issues, patient selection procedures, and methods of scoring and assessment.
Journal ArticleDOI
Global Tests for Multiple Binary Outcomes
Myrto Lefkopoulou,Louise Ryan +1 more
TL;DR: A class of quasi-likelihood score tests for multiple binary outcomes is derived, and it is shown that special cases of this class correspond to other tests that have been proposed, and that these tests can maintain surprisingly high efficiency when the outcomes of interest are rare.
Journal ArticleDOI
Intravenous alteplase for ischaemic stroke
Related Papers (5)
Guidelines for the Early Management of Patients With Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association
William J. Powers,Alejandro A. Rabinstein,Teri Ackerson,Opeolu Adeoye,Nicholas C. Bambakidis,Kyra J. Becker,José Biller,Michael D. Brown,Bart M. Demaerschalk,Brian L. Hoh,Edward C. Jauch,Chelsea S. Kidwell,Thabele M Leslie-Mazwi,Bruce Ovbiagele,Phillip A. Scott,Kevin N. Sheth,Andrew M. Southerland,Deborah V. Summers,David L. Tirschwell +18 more