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Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis

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  • معلومة اضافية
    • Affiliation:
      a University of Edinburgh, Edinburgh, UK
      b Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Oxford, UK
      c University of Glasgow, Glasgow, UK
      d Stanford University, Stanford, CA, USA
      e Boehringer Ingelheim, Ingelheim, Germany
      f Mayo Clinic, Jacksonville, FL, USA
      g University of Melbourne, Melbourne, VIC, Australia
      h Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia
      i Memorial Hermann Hospital, Houston, TX, USA
      j University of Alabama, Birmingham, AL, USA
      k Clinical Neurosciences, Neurology, University of Helsinki, Helsinki, Finland
      l Department of Neurology, Helsinki University Hospital, Helsinki, Finland
      m National Cerebral and Cardiovascular Centre, Suita, Japan
      n Technische Universität, Dresden, Germany
      o The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia
      p Department of Neurology, Cedars-Sinai, Los Angeles, CA, USA
      q Centre Hospitalier Universitaire de Toulouse, France
      r University of Newcastle, Newcastle, NSW, Australia
      s Sapienza University, Rome, Italy
      t Karolinska Institutet, Clinical Neuroscience, Stockholm, Sweden
      u University of Washington, Seattle, WA, USA
      v University of Heidelberg, Heidelberg, Germany
    • Subject Terms:
    • Abstract:
      Summary Background Randomised trials have shown that alteplase improves the odds of a good outcome when delivered within 4·5 h of acute ischaemic stroke. However, alteplase also increases the risk of intracerebral haemorrhage; we aimed to determine the proportional and absolute effects of alteplase on the risks of intracerebral haemorrhage, mortality, and functional impairment in different types of patients.
    • Abstract:
      Findings Data were available from 6756 participants in the nine trials of intravenous alteplase versus control. Alteplase increased the odds of type 2 parenchymal haemorrhage (occurring in 231 [6·8%] of 3391 patients allocated alteplase vs 44 [1·3%] of 3365 patients allocated control; odds ratio [OR] 5·55 [95% CI 4·01–7·70]; absolute excess 5·5% [4·6–6·4]); of SITS-MOST haemorrhage (124 [3·7%] of 3391 vs 19 [0·6%] of 3365; OR 6·67 [4·11–10·84]; absolute excess 3·1% [2·4–3·8]); and of fatal intracerebral haemorrhage (91 [2·7%] of 3391 vs 13 [0·4%] of 3365; OR 7·14 [3·98–12·79]; absolute excess 2·3% [1·7–2·9]). However defined, the proportional increase in intracerebral haemorrhage was similar irrespective of treatment delay, age, or baseline stroke severity, but the absolute excess risk of intracerebral haemorrhage increased with increasing stroke severity: for SITS-MOST intracerebral haemorrhage the absolute excess risk ranged from 1·5% (0·8–2·6%) for strokes with NIHSS 0–4 to 3·7% (2·1–6·3%) for NIHSS 22 or more (p=0·0101). For patients treated within 4·5 h, the absolute increase in the proportion (6·8% [4·0% to 9·5%]) achieving a modified Rankin Scale of 0 or 1 (excellent outcome) exceeded the absolute increase in risk of fatal intracerebral haemorrhage (2·2% [1·5% to 3·0%]) and the increased risk of any death within 90 days (0·9% [–1·4% to 3·2%]).
    • Abstract:
      Interpretation Among patients given alteplase, the net outcome is predicted both by time to treatment (with faster time increasing the proportion achieving an excellent outcome) and stroke severity (with a more severe stroke increasing the absolute risk of intracerebral haemorrhage). Although, within 4·5 h of stroke, the probability of achieving an excellent outcome with alteplase treatment exceeds the risk of death, early treatment is especially important for patients with severe stroke.
    • Abstract:
      Funding UK Medical Research Council, British Heart Foundation, University of Glasgow, University of Edinburgh.
    • ISSN:
      1474-4422
    • Accession Number:
      10.1016/S1474-4422(16)30076-X
    • Accession Number:
      S147444221630076X
    • Copyright:
      © 2016 Elsevier Ltd. All rights reserved.
  • Citations
    • ABNT:
      WHITELEY, W. N. et al. Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis. The Lancet Neurology, [s. l.], v. 15, n. 9, p. 925–933, 2016. DOI 10.1016/S1474-4422(16)30076-X. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S147444221630076X&custid=s8280428. Acesso em: 21 fev. 2020.
    • AMA:
      Whiteley WN, Emberson J, Lees KR, et al. Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis. The Lancet Neurology. 2016;15(9):925-933. doi:10.1016/S1474-4422(16)30076-X.
    • APA:
      Whiteley, W. N., Emberson, J., Lees, K. R., Blackwell, L., Albers, G., Bluhmki, E., Brott, T., Cohen, G., Davis, S., Donnan, G., Grotta, J., Howard, G., Kaste, M., Koga, M., von Kummer, R., Lansberg, M. G., Lindley, R. I., Lyden, P., Olivot, J. M., … Baigent, C. (2016). Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis. The Lancet Neurology, 15(9), 925–933. https://doi.org/10.1016/S1474-4422(16)30076-X
    • Chicago/Turabian: Author-Date:
      Whiteley, William N, Jonathan Emberson, Kennedy R Lees, Lisa Blackwell, Gregory Albers, Erich Bluhmki, Thomas Brott, et al. 2016. “Risk of Intracerebral Haemorrhage with Alteplase after Acute Ischaemic Stroke: A Secondary Analysis of an Individual Patient Data Meta-Analysis.” The Lancet Neurology 15 (9): 925–33. doi:10.1016/S1474-4422(16)30076-X.
    • Harvard:
      Whiteley, W. N. et al. (2016) ‘Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis’, The Lancet Neurology, 15(9), pp. 925–933. doi: 10.1016/S1474-4422(16)30076-X.
    • Harvard: Australian:
      Whiteley, WN, Emberson, J, Lees, KR, Blackwell, L, Albers, G, Bluhmki, E, Brott, T, Cohen, G, Davis, S, Donnan, G, Grotta, J, Howard, G, Kaste, M, Koga, M, von Kummer, R, Lansberg, MG, Lindley, RI, Lyden, P, Olivot, JM, Parsons, M, Toni, D, Toyoda, K, Wahlgren, N, Wardlaw, J, del Zoppo, GJ, Sandercock, P, Hacke, W & Baigent, C 2016, ‘Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis’, The Lancet Neurology, vol. 15, no. 9, pp. 925–933, viewed 21 February 2020, .
    • MLA:
      Whiteley, William N., et al. “Risk of Intracerebral Haemorrhage with Alteplase after Acute Ischaemic Stroke: A Secondary Analysis of an Individual Patient Data Meta-Analysis.” The Lancet Neurology, vol. 15, no. 9, Aug. 2016, pp. 925–933. EBSCOhost, doi:10.1016/S1474-4422(16)30076-X.
    • Chicago/Turabian: Humanities:
      Whiteley, William N, Jonathan Emberson, Kennedy R Lees, Lisa Blackwell, Gregory Albers, Erich Bluhmki, Thomas Brott, et al. “Risk of Intracerebral Haemorrhage with Alteplase after Acute Ischaemic Stroke: A Secondary Analysis of an Individual Patient Data Meta-Analysis.” The Lancet Neurology 15, no. 9 (August 1, 2016): 925–33. doi:10.1016/S1474-4422(16)30076-X.
    • Vancouver/ICMJE:
      Whiteley WN, Emberson J, Lees KR, Blackwell L, Albers G, Bluhmki E, et al. Risk of intracerebral haemorrhage with alteplase after acute ischaemic stroke: a secondary analysis of an individual patient data meta-analysis. The Lancet Neurology [Internet]. 2016 Aug 1 [cited 2020 Feb 21];15(9):925–33. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S147444221630076X&custid=s8280428