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• W2015380360 abstract "HomeStrokeVol. 40, No. 11Expanding Recombinant Tissue Plasminogen Activator Time Window Is Premature Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBExpanding Recombinant Tissue Plasminogen Activator Time Window Is Premature Brian S. Alper, MD, MSPH and Cynthia B. Brown, MD Brian S. AlperBrian S. Alper DynaMed, EBSCO Publishing, Ipswich, Mass Search for more papers by this author and Cynthia B. BrownCynthia B. Brown DynaMed, EBSCO Publishing, Ipswich, Mass Search for more papers by this author Originally published1 Oct 2009https://doi.org/10.1161/STROKEAHA.109.560615Stroke. 2009;40:e632Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: October 1, 2009: Previous Version 1 To the Editor:The American Heart Association/American Stroke Association has expanded the time window for recombinant tissue plasminogen activator from 3 hours to 4.5 hours after stroke onset for many patients.1 The evidence2–7 does not support a Class I recommendation (which will impact clinical care, quality measures, and medicolegal decisions), and we urge the American Heart Association/American Stroke Association to reconsider.The new recommendation is based on the European Cooperative Acute Stroke Study III (ECASS III), a high-quality trial in 821 patients.2 ECASS III found recombinant tissue plasminogen activator within 3 to 4.5 hours after stroke onset to reduce the risk of death or dependency at 90 days (47.6% versus 54.8%, P=0.04, number needed to treat 14) despite an increase in any intracranial hemorrhage (27% versus 17.6% using the National Institute of Neurological Diseases and Stroke definition, P=0.001, number needed to harm 10) and in symptomatic intracranial hemorrhage (7.9% versus 3.5%, P=0.006, number needed to harm 22). In isolation, the ECASS III trial supports the recommendation.However, there are 4 other randomized, placebo-controlled trials to consider. The Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) trial, a high-quality placebo-controlled trial in 613 patients, found recombinant tissue plasminogen activator within 3 to 5 hours after stroke onset had no significant differences in death or dependency at 90 days (66.2% versus 68%), a nonsignificant increase in mortality (11% versus 6.9%, P=0.09), and a significant increase in symptomatic intracranial hemorrhage (7% versus 1.1%, P<0.001, number needed to harm 17).3 Three other randomized, placebo-controlled trials (A0276g, ECASS, ECASS II) evaluated recombinant tissue plasminogen activator within 3 to 6 hours.4–6 Increases in intracranial hemorrhage were fairly consistent, but decreases in death or dependency were inconsistent.Although a single pooled analysis of results from previous trials was reported,1 inconsistencies in the populations, outcome definitions, and results do not support a single pooled analysis.Additional support for the new recommendation used an observational study of patients treated 3 to 4.5 hours (n=664) compared with patients treated within 3 hours after symptom onset (n=11 865).7 The study was summarized as having “no differences” in symptomatic intracerebral hemorrhage and mortality. However, the data suggest worse outcomes in the 3- to 4.5-hour time window group for symptomatic intracerebral hemorrhage (2.2% versus 1.6%, P=0.052) and mortality (12.7% versus 12.2%, P=0.053). A distinction must be made between “no differences” and “no statistically significant differences.” A trend toward harm that approaches the traditional threshold for statistical significance does not establish safety or equivalence.With clear harms consistent across trials and inconsistent evidence for benefit, a Class I recommendation is not warranted. Further research establishing benefit in another high-quality randomized, placebo-controlled trial should be completed before making recombinant tissue plasminogen activator 3 to 4.5 hours after stroke onset a standard of care.DisclosuresB.S.A. is Editor-in-Chief and C.B.B. is Deputy Editor of DynaMed, an evidence-based clinical reference.1 Del Zoppo GJ, Saver JL, Jauch EC, Adams HP Jr; on behalf of the American Heart Association Stroke Council. Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator. A science advisory from the American Heart Association/American Stroke Association. Stroke. 2009; 40: 2945–2948.LinkGoogle Scholar2 Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008; 359: 1317–1329.CrossrefMedlineGoogle Scholar3 Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. JAMA. 1999; 282: 2019–2026.CrossrefMedlineGoogle Scholar4 Clark WM, Albers GW, Madden KP, Hamilton S; Thromblytic Therapy in Acute Ischemic Stroke Study Investigators. The rtPA (alteplase) 0- to 6-hour acute stroke trial, part A (A0276g): results of a double-blind, placebocontrolled, multicenter study. Stroke. 2000; 31: 811–816.CrossrefMedlineGoogle Scholar5 Hacke W, Kaste M, Fieschi C, Toni D, Lesaffre E, von Kummer R, Boysen G, Bluhmki E, Höxter G, Mahagne MH, Hennerichi M. Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS). JAMA. 1995; 274: 1017–1025.CrossrefMedlineGoogle Scholar6 Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Second European-Australasian Acute Stroke Study Investigators. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Lancet. 1998; 352: 1245–1251.CrossrefMedlineGoogle Scholar7 Wahlgren N, Ahmed N, Dávalos A, Hacke W, Millán M, Muir K, Roine RO, Toni D, Lees KR; SITS investigators. Thrombolysis with alteplase 3–4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008; 372: 1303–1309.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Li G, Walter S and Thabane L (2021) Shifting the focus away from binary thinking of statistical significance and towards education for key stakeholders: revisiting the debate on whether it's time to de-emphasize or get rid of statistical significance, Journal of Clinical Epidemiology, 10.1016/j.jclinepi.2021.03.033, 137, (104-112), Online publication date: 1-Sep-2021. Alper B, Foster G, Thabane L, Rae-Grant A, Malone-Moses M and Manheimer E (2020) Thrombolysis with alteplase 3–4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances, BMJ Evidence-Based Medicine, 10.1136/bmjebm-2020-111386, 25:5, (168-171), Online publication date: 1-Oct-2020. November 2009Vol 40, Issue 11 Advertisement Article InformationMetrics https://doi.org/10.1161/STROKEAHA.109.560615PMID: 19797699 Originally publishedOctober 1, 2009 Keywordsthrombolytic Rxthrombolysisstroke managementPDF download Advertisement" @default.
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