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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThere has been considerable debate regarding the use of intravenous recombinant tissue plasminogen activator (IV-rtPA) in patients with mild stroke symptoms. It has been unclear whether the potential benefits of improvement in neurologic outcomes outweigh the potential risks of hemorrhagic stroke, increased impairment, and death. This article presents results from a post hoc analysis of data from a subset of patients from the Third International Stroke Trial [IST-3; \u003Ca href=\u0022\/external-ref?link_type=ISRCTN\u0026amp;access_num=ISRCTN25765518\u0022 class=\u0022external-ref external-ref-type-isrctn\u0022\u003EISRCTN25765518\u003C\/a\u003E], indicating that patients with mild stroke symptoms (ie, those having a National Institutes of Health Stroke Score of 0 to 5) may benefit from IV-rtPA.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIschemia\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIschemia\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThere has been considerable debate regarding the use of intravenous recombinant tissue plasminogen activator (IV-rtPA) inpatients with mild stroke symptoms. It has been unclear whether the potential benefits of improvement in neurologic outcomes outweigh the potential risks of hemorrhagic stroke, increased impairment, and death. Pooja Khatri, MD, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA, presented results from a post hoc analysis of data from a subset of patients from the Third International Stroke Trial [IST-3; \u003Ca href=\u0022\/external-ref?link_type=ISRCTN\u0026amp;access_num=ISRCTN25765518\u0022 class=\u0022external-ref external-ref-type-isrctn\u0022\u003EISRCTN25765518\u003C\/a\u003E], indicating that patients with mild stroke symptoms (ie, those having a National Institutes of Health Stroke Score of 0 to 5) may benefit from IV-rtPA.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIST-3 was a Phase 3 randomized open-label trial that compared IV-rtPA administered within 6 hours of symptom onset to a placebo control. A total of 3035 patients were enrolled from 12 countries outside the United States, of which 612 had mild stroke symptoms [IST-3 Collaborative Group. \u003Cem\u003ELancet\u003C\/em\u003E 2012]. Among those with mild strokes who were treated with IV-rtPA or placebo, there were no differences in the primary endpoint of being alive and independent (Oxford Handicap Score [OHS], 0 to 2) at 6 months (73% vs 75%, respectively; odds ratio [OR], 0.85; 99% CI 0.52 to 1.38). Mild stroke patients treated with IV-rtPA also had a higher risk of symptomatic intracranial hemorrhage compared with control patients (3% vs 0%, respectively).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EKhatri and her colleagues performed a post hoc analysis on the IST-3 data to examine the effect of IV-rtPA in a more restricted subset of IST-3 patients with mild stroke. This subset included patients of any age in the IST-3 who had a mild stroke, received IV-rtPA \u0026lt;3 hours after symptom onset, had a pretreatment blood pressure \u0026lt;185\/110 mm Hg, and met all other National Institute of Neurological Disorders and Stroke tissue plasminogen activator study criteria. The primary outcome was being alive and independent at 6 months (OHS, 0 to 2). Key secondary outcomes included an ordinal analysis of OHS and the proportion of patients who were alive and independent with a favorable outcome at 6 months (OHS, 0 to 1). Outcomes were adjusted for age, time to randomization, and presence of ischemic change on baseline scan.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAbout 20% (n=612) of subjects enrolled in the IST-3 trial had a mild stroke. Of these, 106 met the restricted criteria for the post hoc analysis. Among these patients, IV-rtPA was associated with an increase in being alive and independent at 6 months versus control, with an OHS of 0 to 2 (84% vs 65%, respectively; adjusted OR, 3.31; 95% CI, 1.24 to 8.79; p=0.02). The IV-rtPA effect on having a favorable outcome was not significant as compared to control (60% vs 51%, respectively; adjusted OR, 1.92; 95% CI, 0.83 to 4.43, p=0.13; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). There were no reports of symptomatic intracerebral hemorrhage in any of these 106 patients with mild stroke who received IV-rtPA.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15891\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15891\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15891\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EOutcomes\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003ELimitations of this study include the highly restricted subset and sample size, which is too small to reliably estimate the risk of symptomatic intracerebral hemorrhage. However, this post hoc analysis showed that the use of IV-rtPA\u2014in patients with a mild stroke and a pretreatment blood pressure \u0026lt;185\/110 mm Hg who can be treated within \u0026lt;3 hours after symptom onset\u2014was associated with an increase in odds of being alive and independent at 6 months. As such, a new Phase 3 trial of IV-rtPA in patients with mild stroke has been initiated: \u201cA Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke\u201d [PRISMS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02072226\u0026amp;atom=%2Fspmdc%2F14%2F6%2F14.atom\u0022\u003ENCT02072226\u003C\/a\u003E]. PRISMS is expected to enroll 950 patients with a mild stroke, defined as a National Institutes of Health Stroke Score of 0 to 5, from 75 centers in the United States. It is hoped that the PRISMS trial will provide definitive data regarding the efficacy of IV-rtPA in patients with a mild stroke.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/6\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzpa3q\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzpa3q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}