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Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials.

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  • معلومة اضافية
    • Author-Supplied Keywords:
      anticoagulants
      atrial fibrillation
      clinical trial
      major bleeding
      venous thromboembolism
    • Abstract:
      Background Clinically relevant bleeding ( CRB), comprising major bleeding and clinically relevant non-major bleeding, has been used as a surrogate for major bleeding in most anticoagulant trials. The validity of this surrogate to estimate trade-off between thrombotic and bleeding events in clinical trials was never assessed. Methods We systematically reviewed randomized phase III trials comparing new anticoagulants with the standard of care for venous thromboembolism prevention following major orthopedic surgery, venous thromboembolism ( VTE) treatment, or stroke and systemic embolism prevention in atrial fibrillation ( AF), and reporting both major bleeding and CRB rates. The validity of CRB as a surrogate for major bleeding was assessed according to the strength of the association between the relative risks of major bleeding and CRB, measured by the use of R2trial and its 95% confidence interval ( CI). Results In the postoperative prophylactic setting (13 studies), major bleeding and CRB rates were 1.12% and 3.56%, respectively, and R2trial was 0.69 (95% CI 0.34-0.93). For acute VTE studies ( n = 12), major bleeding and CRB rates were 1.87% and 9.07%; the corresponding R2trial values were 0.28 (95% CI 0.01-0.80) and 0.68 (95% CI 0.09-1.00) when only double-blind studies were considered ( n = 7). For AF studies ( n = 7; 22 strata), major bleeding and CRB rates were 4.82% and 15.3%, and R2trial was 0.59 (95% CI 0.15-0.82). Conclusion Despite an apparent correlation between CRB and major bleeding in major orthopedic surgery, AF, and double-blind acute VTE studies, the wide CIs suggest that CRB might not be an acceptable surrogate outcome in any of these settings. [ABSTRACT FROM AUTHOR]
    • Abstract:
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    • Author Affiliations:
      1SAINBIOSE U1059, Université Jean Monnet, Université de Lyon, INSERM, Saint‐Etienne France
      2Unité de Recherche Clinique, Innovation, Pharmacologie, CHU Saint‐Etienne, Hôpital Nord, Saint‐Etienne France
      3Service de Médecine Vasculaire et Thérapeutique, CHU Saint‐Etienne, Hôpital Nord, Saint‐Etienne France
      4Laboratoire de Pharmacologie, Toxicologie et Gaz du sang, CHU Saint‐Etienne, Hôpital Nord, Saint‐Etienne France
      5Unité de Recherche Clinique Innovation, Pharmacologie, and Service d'Anesthésie Réanimation, CHU Saint‐Etienne, Hôpital Nord, Saint‐Etienne France
      6Département de Médecine Interne et Pathologie Vasculaire, Hôpital Lyon Sud, CHU Lyon, Pierre‐Bénite France
      7UMR CNRS 5558 Evaluation et Modelisation des Effets Therapeutiques, Université Claude Bernard Lyon 1, Lyon France
      8Inserm CIE1408, F‐CRIN INNOVTE Network, Paris France
      9Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton Ontario, Canada
      10Hopital Européen Georges Pompidou, APHP, Université Paris Descartes, Sorbonne Paris Cité, INSERM UMRs 970, CIE1418, F‐CRIN INNOVTE Network, Paris France
    • ISSN:
      1538-7933
    • Accession Number:
      10.1111/jth.13740
    • Accession Number:
      124417040
  • Citations
    • ABNT:
      LAPORTE, S. et al. Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials. Journal of Thrombosis & Haemostasis, [s. l.], v. 15, n. 8, p. 1547–1558, 2017. DOI 10.1111/jth.13740. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=124417040&custid=s8280428. Acesso em: 4 ago. 2020.
    • AMA:
      Laporte S, Chapelle C, Bertoletti L, et al. Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials. Journal of Thrombosis & Haemostasis. 2017;15(8):1547-1558. doi:10.1111/jth.13740.
    • AMA11:
      Laporte S, Chapelle C, Bertoletti L, et al. Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials. Journal of Thrombosis & Haemostasis. 2017;15(8):1547-1558. doi:10.1111/jth.13740
    • APA:
      Laporte, S., Chapelle, C., Bertoletti, L., Ollier, E., Zufferey, P., Lega, J. ‐C., Merah, A., Décousus, H., Schulman, S., Meyer, G., Cucherat, M., & Mismetti, P. (2017). Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials. Journal of Thrombosis & Haemostasis, 15(8), 1547–1558. https://doi.org/10.1111/jth.13740
    • Chicago/Turabian: Author-Date:
      Laporte, S., C. Chapelle, L. Bertoletti, E. Ollier, P. Zufferey, J.‐C. Lega, A. Merah, et al. 2017. “Assessment of Clinically Relevant Bleeding as a Surrogate Outcome for Major Bleeding: Validation by Meta-Analysis of Randomized Controlled Trials.” Journal of Thrombosis & Haemostasis 15 (8): 1547–58. doi:10.1111/jth.13740.
    • Harvard:
      Laporte, S. et al. (2017) ‘Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials’, Journal of Thrombosis & Haemostasis, 15(8), pp. 1547–1558. doi: 10.1111/jth.13740.
    • Harvard: Australian:
      Laporte, S, Chapelle, C, Bertoletti, L, Ollier, E, Zufferey, P, Lega, J ‐C., Merah, A, Décousus, H, Schulman, S, Meyer, G, Cucherat, M & Mismetti, P 2017, ‘Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials’, Journal of Thrombosis & Haemostasis, vol. 15, no. 8, pp. 1547–1558, viewed 4 August 2020, .
    • MLA:
      Laporte, S., et al. “Assessment of Clinically Relevant Bleeding as a Surrogate Outcome for Major Bleeding: Validation by Meta-Analysis of Randomized Controlled Trials.” Journal of Thrombosis & Haemostasis, vol. 15, no. 8, Aug. 2017, pp. 1547–1558. EBSCOhost, doi:10.1111/jth.13740.
    • Chicago/Turabian: Humanities:
      Laporte, S., C. Chapelle, L. Bertoletti, E. Ollier, P. Zufferey, J.‐C. Lega, A. Merah, et al. “Assessment of Clinically Relevant Bleeding as a Surrogate Outcome for Major Bleeding: Validation by Meta-Analysis of Randomized Controlled Trials.” Journal of Thrombosis & Haemostasis 15, no. 8 (August 2017): 1547–58. doi:10.1111/jth.13740.
    • Vancouver/ICMJE:
      Laporte S, Chapelle C, Bertoletti L, Ollier E, Zufferey P, Lega J ‐C., et al. Assessment of clinically relevant bleeding as a surrogate outcome for major bleeding: validation by meta-analysis of randomized controlled trials. Journal of Thrombosis & Haemostasis [Internet]. 2017 Aug [cited 2020 Aug 4];15(8):1547–58. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=124417040&custid=s8280428