MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design

G. Landoni, V. Lomivorotov, A. Pisano, C. Nigro Neto, U. Benedetto, G. Biondi Zoccai, M. Gemma, S. Frassoni, F.E. Agrò, M. Baiocchi, F.R. Barbosa Gomes Galas, A. Bautin, N. Bradic, C. Carollo, G. Crescenzi, A.M. Elnakera, M.R. El-Tahan, E. Fominskiy, A.G. Farag, G. GazivodaS. Gianni, E. Grigoryev, F. Guarracino, S. Hanafi, W. Huang, G. Kunst, J. Kunstyr, C. Lei, R. Lembo, Z.-J. Li, V. Likhvantsev, A. Lozovskiy, J. Ma, F. Monaco, P. Navalesi, B. Nazar, V. Pasyuga, E. Porteri, C. Royse, L. Ruggeri, H. Riha, F. Santos Silva, L. Severi, V. Shmyrev, N. Uvaliev, C.B. Wang, C.-Y. Wang, D. Winterton, C.-Y. Yong, A. Zangrillo

Research output: Contribution to journalArticle

Abstract

Objective There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable. Design Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio. Setting Tertiary and University hospitals. Interventions Patients (n = 10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia. Measurements and main results The primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30 day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9. Conclusions The trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery. © 2017 Elsevier Inc.
Original languageEnglish
Pages (from-to)38-43
Number of pages6
JournalContemporary Clinical Trials
Volume59
DOIs
Publication statusPublished - 2017

Keywords

  • Cardiac anesthesia
  • Cardiac surgery
  • Intensive care
  • Randomized trial
  • Total intravenous anesthesia
  • Volatile anesthetics
  • desflurane
  • fentanyl
  • isoflurane
  • midazolam
  • propofol
  • remifentanil
  • sevoflurane
  • sufentanil
  • adult
  • Article
  • cardiopulmonary bypass
  • cardiovascular mortality
  • clinical outcome
  • controlled study
  • coronary artery bypass graft
  • follow up
  • heart infarction
  • human
  • hypothesis
  • inhalation anesthesia
  • intensive care unit
  • intravenous anesthesia
  • major clinical study
  • multicenter study
  • postoperative period
  • randomized controlled trial
  • sample size
  • single blind procedure
  • study design

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  • Cite this

    Landoni, G., Lomivorotov, V., Pisano, A., Nigro Neto, C., Benedetto, U., Biondi Zoccai, G., Gemma, M., Frassoni, S., Agrò, F. E., Baiocchi, M., Barbosa Gomes Galas, F. R., Bautin, A., Bradic, N., Carollo, C., Crescenzi, G., Elnakera, A. M., El-Tahan, M. R., Fominskiy, E., Farag, A. G., ... Zangrillo, A. (2017). MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design. Contemporary Clinical Trials, 59, 38-43. https://doi.org/10.1016/j.cct.2017.05.011