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      • Record: found
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      Is Open Access

      Effect of IV alteplase on the ischemic brain lesion at 24–48 hours after ischemic stroke

      research-article
      Author(s): , MD, , MD, , MBBS, , MD, , MBBS, , MD, , MD, , MD, , MD, , MD, , DM, , MD, , MD , for the IST-3 Collaborative Group
      Other contributor(s): (Collab), , DM (Collab), , MD (Collab), , MD (Collab)
      Publication date PMC-release:
      Journal: Neurology
      Publisher: Lippincott Williams & Wilkins

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          Abstract

          Objective

          To determine whether alteplase alters the development of ischemic lesions on brain imaging after stroke.

          Methods

          The Third International Stroke Trial (IST-3) was a randomized controlled trial of IV alteplase for ischemic stroke. We assessed CT or brain MRI at baseline (pretreatment) and 24 to 48 hours posttreatment for acute lesion visibility, extent, and swelling, masked to all other data. We analyzed associations between treatment allocation, change in brain tissue appearances between baseline and follow-up imaging, and 6-month functional outcome in IST-3. We performed a meta-analysis of randomized trials of alteplase vs control with pre- and postrandomization imaging.

          Results

          Of 3,035 patients recruited in IST-3, 2,916 had baseline and follow-up brain imaging. Progression in either lesion extent or swelling independently predicted poorer 6-month outcome (adjusted odds ratio [OR] = 0.92, 95% confidence interval [CI] 0.88–0.96, p < 0.001; OR = 0.73, 95% CI 0.66–0.79, p < 0.001, respectively). Patients allocated alteplase were less likely than controls to develop increased lesion visibility at follow-up (OR = 0.77, 95% CI 0.67–0.89, p < 0.001), but there was no evidence that alteplase reduced progression of lesion extent or swelling. In meta-analysis of 6 trials including IST-3 (n = 4,757), allocation to alteplase was associated with a reduction in ischemic lesion extent on follow-up imaging (OR = 0.85, 95% CI 0.76–0.95, p = 0.004).

          Conclusion

          Alteplase was associated with reduced short-term progression in lesion visibility. In meta-analysis, alteplase reduced lesion extent. These findings may indicate that alteplase improves functional outcome by reducing tissue damage.

          Classification of evidence

          This study provides Class II evidence that IV alteplase impedes the progression of ischemic brain lesions on imaging after stroke.

          Related collections

          Most cited references23

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          Effects of alteplase beyond 3 h after stroke in the Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET): a placebo-controlled randomised trial.

          Stephen M Davis, Geoffrey Donnan, Mark W. Parsons … (2008)
          Whether intravenous tissue plasminogen activator (alteplase) is effective beyond 3 h after onset of acute ischaemic stroke is unclear. We aimed to test whether alteplase given 3-6 h after stroke onset promotes reperfusion and attenuates infarct growth in patients who have a mismatch in perfusion-weighted MRI (PWI) and diffusion-weighted MRI (DWI). We prospectively and randomly assigned 101 patients to receive alteplase or placebo 3-6 h after onset of ischaemic stroke. PWI and DWI were done before and 3-5 days after therapy, with T2-weighted MRI at around day 90. The primary endpoint was infarct growth between baseline DWI and the day 90 T2 lesion in mismatch patients. Major secondary endpoints were reperfusion, good neurological outcome, and good functional outcome. Patients, caregivers, and investigators were unaware of treatment allocations. Primary analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00238537. We randomly assigned 52 patients to alteplase and 49 patients to placebo. Mean age was 71.6 years, and median score on the National Institutes of Health stroke scale was 13. 85 of 99 (86%) patients had mismatch of PWI and DWI. The geometric mean infarct growth (exponential of the mean log of relative growth) was 1.24 with alteplase and 1.78 with placebo (ratio 0.69, 95% CI 0.38-1.28; Student's t test p=0.239); the median relative infarct growth was 1.18 with alteplase and 1.79 with placebo (ratio 0.66, 0.36-0.92; Wilcoxon's test p=0.054). Reperfusion was more common with alteplase than with placebo and was associated with less infarct growth (p=0.001), better neurological outcome (p<0.0001), and better functional outcome (p=0.010) than was no reperfusion. Alteplase was non-significantly associated with lower infarct growth and significantly associated with increased reperfusion in patients who had mismatch. Because reperfusion was associated with improved clinical outcomes, phase III trials beyond 3 h after treatment are warranted.
          Article 0 comments Cited 204 times – based on 0 reviews     Review now
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            DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4·5 h of symptom onset (PRE-FLAIR): a multicentre observational study.

            Götz Thomalla, Bastian Cheng, Martin Ebinger … (2011)
            Many patients with stroke are precluded from thrombolysis treatment because the time from onset of their symptoms is unknown. We aimed to test whether a mismatch in visibility of an acute ischaemic lesion between diffusion-weighted MRI (DWI) and fluid-attenuated inversion recovery (FLAIR) MRI (DWI-FLAIR mismatch) can be used to detect patients within the recommended time window for thrombolysis. In this multicentre observational study, we analysed clinical and MRI data from patients presenting between Jan 1, 2001, and May 31, 2009, with acute stroke for whom DWI and FLAIR were done within 12 h of observed symptom onset. Two neurologists masked to clinical data judged the visibility of acute ischaemic lesions on DWI and FLAIR imaging, and DWI-FLAIR mismatch was diagnosed by consensus. We calculated predictive values of DWI-FLAIR mismatch for the identification of patients with symptom onset within 4·5 h and within 6 h and did multivariate regression analysis to identify potential confounding covariates. This study is registered with ClinicalTrials.gov, number NCT01021319. The final analysis included 543 patients. Mean age was 66·0 years (95% CI 64·7-67·3) and median National Institutes of Health Stroke Scale score was 8 (IQR 4-15). Acute ischaemic lesions were identified on DWI in 516 patients (95%) and on FLAIR in 271 patients (50%). Interobserver agreement for acute ischaemic lesion visibility on FLAIR imaging was moderate (κ=0·569, 95% CI 0·504-0·634). DWI-FLAIR mismatch identified patients within 4·5 h of symptom onset with 62% (95% CI 57-67) sensitivity, 78% (72-84) specificity, 83% (79-88) positive predictive value, and 54% (48-60) negative predictive value. Multivariate regression analysis identified a longer time to MRI (p<0·0001), a lower age (p=0·0009), and a larger DWI lesion volume (p=0·0226) as independent predictors of lesion visibility on FLAIR imaging. Patients with an acute ischaemic lesion detected with DWI but not with FLAIR imaging are likely to be within a time window for which thrombolysis is safe and effective. These findings lend support to the use of DWI-FLAIR mismatch for selection of patients in a future randomised trial of thrombolysis in patients with unknown time of symptom onset. Else Kröner-Fresenius-Stiftung, National Institutes of Health. Copyright © 2011 Elsevier Ltd. All rights reserved.
            Article 0 comments Cited 132 times – based on 0 reviews     Review now
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              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.

              W Clark, S Wissman, G W Albers … (1999)
              Recombinant tissue-type plasminogen activator (rt-PA) improves outcomes for patients with acute ischemic stroke, but current approved use is limited to within 3 hours of symptom onset. This restricts the number of patients who can be treated, since most stroke patients present more than 3 hours after symptom onset. To test the efficacy and safety of rt-PA in patients with acute ischemic stroke when administered between 3 and 5 hours after symptom onset. The Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) study is a phase 3, placebo-controlled, double-blind randomized study conducted between December 1993 and July 1998, with up to 90 days of follow-up. One hundred forty university and community hospitals in North America. An intent-to-treat population of 613 acute ischemic stroke patients was enrolled, with 547 of these treated as assigned within 3 to 5 hours of symptom onset. A total of 39 others were treated within 3 hours of symptom onset, 24 were treated more than 5 hours after symptom onset, and 3 never received any study drug. Administration of 0.9 mg/kg of rt-PA (n = 272) or placebo (n = 275) intravenously over 1 hour. Primary efficacy was an excellent neurologic recovery at day 90 (National Institutes of Health Stroke Scale [NIHSS] score of < or =1); secondary end points included excellent recovery on functional outcome measures (Barthel index, modified Rankin scale, and Glasgow Outcome Scale) at days 30 and 90. Serious adverse events were also assessed. In the target population, 32% of the placebo and 34% of rt-PA patients had an excellent recovery at 90 days (P = .65). There were no differences on any of the secondary functional outcome measures. In the first 10 days treatment with rt-PA significantly increased the rate of symptomatic intracerebral hemorrhage (ICH) (1.1% vs 7.0% [P<.001]), a symptomatic ICH (4.7% vs 11.4% [P = .004]), and fatal ICH (0.3% vs 3.0% [P<.001]). Mortality at 90 days was 6.9% with placebo and 11.0% with rt-PA (P = .09). Results in the intent-to-treat population were similar. This study found no significant rt-PA benefit on the 90-day efficacy end points in patients treated between 3 and 5 hours. The risk of symptomatic ICH increased with rt-PA treatment. These results do not support the use of intravenous rt-PA for stroke treatment beyond 3 hours.
              Article 0 comments Cited 71 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Grant Mair:
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                1. 1) Get Through First FRCR: MCQs for the Physics Module. CRC Press. 2009 2) Get Through First FRCR: Questions for the Anatomy Module. CRC Press. 2011

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                Rüdiger von Kummer:
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                1. Neuroradiology, Editor in Chief since 2017

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                1. Commercial. Bayer. Lecture fee paid to my Department to give invited lecture at conference

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                1. stroke - editorial board member, International Journal of Stroke - editorial board member, Cochrane Stroke Group - editorial board member

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                1. Stroke: The Facts. Lindley RI. Oxford University Press 2008. ISBN 978-0-19-921272-9 2nd Edition, 2017, ISBN 978-0-19-877818-9 Understanding Stroke. Lindley RI. The British Medical Association Family Doctor Series. ISBN: 1 898205 60 4. Published by Family Doctor Publications Ltd in association with the British Medical Association 2000. Second edition 2002. Third Edition 2003. Fourth edition 2005.

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                1. 1) INTERACT: a randomised trial of intensive blood pressure lowering in acute intracerebral haemorrhage. Anderson C, Chalmers J, Wang J, Lindley R. 2) NHMRC (Australia) Project Grant 512402;Chief Investigator 2008-11. 3) NHMRC (Australia) Partnership Grant 569328, Chief Investigator, 2010-2014. 4) NHMRC (Australia) Project Grant APP1004170, Chief Investigator 2011-13. 5) NHMRC (Australia) Project Grant, APP1020462 Chief Investigator, 2012-2015 6) NHMRC (Australia) Project Grant, APP1024440, Chief Investigator, 2012-14 7) NHMRC (Australia) Project Grant, APP1041401, Chief Investigator 2013-6 8) NHMRC (Australia) Project Grant. APP1045391 Chief Investigator, 2013-6 9) NHMRC (Australia) Project Grant,APP1063751 Chief Investigator, 2014-6 10) NHMRC (Australia) Project Grant, APP1101113 Chief Investigator, 2016-8 11) NHMRC (Australia) Program Grant, APP1149987 Chief Investigator, 2019-23

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                1. Medical Research Council; Efficacy and Mechanisms Evaluation; Stroke Association; Health Foundation; and Chest Heart Stroke Scotland for this work. Prof Wardlaw also receives funding from the Fondation Leducq, the European Union Horizon 2020 project No 666881, ?SVDs@target', UK Medical Research Council, Engineering and Physical Sciences Research Council, British Heart Foundation, Alzheimer's Society, Chief Scientist Office.

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                Research Support, Foundations and Societies:

                1. The Row Fogo Trust. ?1,496,000, 1st Apr 2001 to 31st Jul 2021. Ref No: AD.ROW4.35.

                Stock/Stock Options/Board of Directors Compensation:

                1. NONE

                License Fee Payments, Technology or Inventions:

                1. NONE

                Royalty Payments, Technology or Inventions:

                1. NONE

                Stock/Stock Options, Research Sponsor:

                1. NONE

                Stock/Stock Options, Medical Equipment & Materials:

                1. NONE

                Legal Proceedings:

                1. NONE

                Journal
                Journal ID (nlm-ta): Neurology
                Journal ID (iso-abbrev): Neurology
                Journal ID (hwp): neurology
                Journal ID (publisher-id): neur
                Journal ID (pmc): neurology
                Journal ID (publisher-id): NEUROLOGY
                Title: Neurology
                Publisher: Lippincott Williams & Wilkins (Hagerstown, MD )
                ISSN (Print): 0028-3878
                ISSN (Electronic): 1526-632X
                Publication date (Print): 27 November 2018
                Publication date PMC-release: 27 November 2018
                Volume: 91
                Issue: 22
                Pages: e2067-e2077
                Affiliations
                From Edinburgh Imaging, and UK Dementia Research Institute at the University of Edinburgh and Centre for Clinical Brain Sciences (G.M., Z.M., A.J.F., J.M.W.), and Division of Clinical Neurosciences (P.A.G.S.), University of Edinburgh, UK; Department of Neuroradiology (R.v.K.), Dresden University Stroke Centre, Germany; Danderyd Hospital (A.v.H.), Stockholm, Sweden; Neuroradiology (N.B.), James Cook University Hospital, Middlesborough, UK; School of Medicine (L.C.), University of Western Australia; Cliniques Universitaires St Luc (A.P.), Neurologie, Belgium; Stroke Center (A.A.), Department of Neurology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy; Department of Neuroradiology (G.P.), Salford Royal NHS Foundation Trust, Manchester, UK; and Westmead Hospital Clinical School and The George Institute for Global Health (R.I.L.), University of Sydney, Australia.
                Author notes
                Correspondence Prof. Wardlaw joanna.wardlaw@ 123456ed.ac.uk

                Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

                IST-3 Collaborative Group coinvestigators are listed at links.lww.com/WNL/A749.

                The Article Processing Charge was funded by RCUK.

                Article
                Publisher ID: NEUROLOGY2018892109
                DOI: 10.1212/WNL.0000000000006575
                PMC ID: 6282236
                PubMed ID: 30366975
                SO-VID: db9136a8-fe7a-4285-8307-41bc95cf86fd
                Copyright © Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 12 March 2018
                Date accepted : 14 August 2018
                Funding
                Funded by: Medical Research Council
                Award ID: MRC G0400069 and EME 09-800-15
                Categories
                Subject: 6
                Subject: 20
                Subject: 119
                Subject: 120
                Subject: Article
                Custom metadata
                OPEN-ACCESS TRUE
                STATUS ONLINE-ONLY

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