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

Giovanni Landoni; Vladimir Lomivorotov; Antonio Pisano; Caetano Nigro Neto; Umberto Benedetto; Giuseppe Biondi Zoccai; Marco Gemma; Samuele Frassoni; Felice Eugenio Agrò; Massimo Baiocchi; Filomena R. Barbosa Gomes Galas; Andrei Bautin; Nikola Bradic; Cristiana Carollo; Giuseppe Crescenzi; Abeer Elnakera; Mohamed R. El-Tahan; Evgeny Fominskiy; Ahmed G. Farag; Gordana Gazivoda; Stefano Gianni; Evgeny Grigoryev; Fabio Guarracino; Sidik Hanafi; Weiqing Huang; Gudrun Kunst; Jan Kunstyr; Chong Lei; Rosalba Lembo; Zhi-jian Li; Valery Likhvantsev; Andrey Lozovskiy; Jun Ma; Fabrizio Monaco; Paolo Navalesi; Bukamal Nazar; Vadim Pasyuga; Elena Porteri; Colin Royse; Laura Ruggeri; Hynek Ryha; Fernanda Santos Silva; Luca Severi; Vladimir Shmyrev; Nikolay Uvaliev; Cheng Bin Wang; Chew-Yin Wang; Dario Winterton; Chow-Yen Yong; Jingui Yu; Rinaldo Bellomo; Alberto Zangrillo

doi:10.1016/j.cct.2017.05.011

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

Giovanni Landoni, Vladimir Lomivorotov, Antonio Pisano, Caetano Nigro Neto, Umberto Benedetto, Giuseppe Biondi Zoccai, Marco Gemma, Samuele Frassoni, Felice Eugenio Agrò, Massimo Baiocchi, Filomena R. Barbosa Gomes Galas, Andrei Bautin, Nikola Bradic, Cristiana Carollo, Giuseppe Crescenzi, Abeer Elnakera, Mohamed R. El-Tahan, Evgeny Fominskiy, Ahmed G. Farag, Gordana GazivodaStefano Gianni, Evgeny Grigoryev, Fabio Guarracino, Sidik Hanafi, Weiqing Huang, Gudrun Kunst, Jan Kunstyr, Chong Lei, Rosalba Lembo, Zhi-jian Li, Valery Likhvantsev, Andrey Lozovskiy, Jun Ma, Fabrizio Monaco, Paolo Navalesi, Bukamal Nazar, Vadim Pasyuga, Elena Porteri, Colin Royse, Laura Ruggeri, Hynek Ryha, Fernanda Santos Silva, Luca Severi, Vladimir Shmyrev, Nikolay Uvaliev, Cheng Bin Wang, Chew-Yin Wang, Dario Winterton, Chow-Yen Yong, Jingui Yu, Rinaldo Bellomo, Alberto Zangrillo

Bristol Medical School (THS)

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Abstract

AbstractObjective 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.

Original language	English
Pages (from-to)	38-43
Number of pages	6
Journal	Contemporary Clinical Trials
Volume	59
Early online date	19 May 2017
DOIs	https://doi.org/10.1016/j.cct.2017.05.011
Publication status	E-pub ahead of print - 19 May 2017

Keywords

Volatile anesthetics
Total intravenous anesthesia
Cardiac anesthesia
Cardiac surgery
Randomized trial
Intensive care

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Landoni, G., Lomivorotov, V., Pisano, A., Neto, C. N., Benedetto, U., Zoccai, G. B., Gemma, M., Frassoni, S., Agrò, F. E., Baiocchi, M., Barbosa Gomes Galas, F. R., Bautin, A., Bradic, N., Carollo, C., Crescenzi, G., Elnakera, A., 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. Advance online publication. https://doi.org/10.1016/j.cct.2017.05.011

@article{3fcd42c51f984718a0094f8f78a9f050,

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

abstract = "AbstractObjective 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.",

keywords = "Volatile anesthetics, Total intravenous anesthesia, Cardiac anesthesia, Cardiac surgery, Randomized trial, Intensive care",

author = "Giovanni Landoni and Vladimir Lomivorotov and Antonio Pisano and Neto, {Caetano Nigro} and Umberto Benedetto and Zoccai, {Giuseppe Biondi} and Marco Gemma and Samuele Frassoni and Agr{\`o}, {Felice Eugenio} and Massimo Baiocchi and {Barbosa Gomes Galas}, {Filomena R.} and Andrei Bautin and Nikola Bradic and Cristiana Carollo and Giuseppe Crescenzi and Abeer Elnakera and El-Tahan, {Mohamed R.} and Evgeny Fominskiy and Farag, {Ahmed G.} and Gordana Gazivoda and Stefano Gianni and Evgeny Grigoryev and Fabio Guarracino and Sidik Hanafi and Weiqing Huang and Gudrun Kunst and Jan Kunstyr and Chong Lei and Rosalba Lembo and Zhi-jian Li and Valery Likhvantsev and Andrey Lozovskiy and Jun Ma and Fabrizio Monaco and Paolo Navalesi and Bukamal Nazar and Vadim Pasyuga and Elena Porteri and Colin Royse and Laura Ruggeri and Hynek Ryha and Silva, {Fernanda Santos} and Luca Severi and Vladimir Shmyrev and Nikolay Uvaliev and Wang, {Cheng Bin} and Chew-Yin Wang and Dario Winterton and Chow-Yen Yong and Jingui Yu and Rinaldo Bellomo and Alberto Zangrillo",

year = "2017",

month = may,

day = "19",

doi = "10.1016/j.cct.2017.05.011",

language = "English",

volume = "59",

pages = "38--43",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier Inc.",

}

Landoni, G, Lomivorotov, V, Pisano, A, Neto, CN, Benedetto, U, Zoccai, GB, Gemma, M, Frassoni, S, Agrò, FE, Baiocchi, M, Barbosa Gomes Galas, FR, Bautin, A, Bradic, N, Carollo, C, Crescenzi, G, Elnakera, A, El-Tahan, MR, Fominskiy, E, Farag, AG, Gazivoda, G, Gianni, S, Grigoryev, E, Guarracino, F, Hanafi, S, Huang, W, Kunst, G, Kunstyr, J, Lei, C, Lembo, R, Li, Z, Likhvantsev, V, Lozovskiy, A, Ma, J, Monaco, F, Navalesi, P, Nazar, B, Pasyuga, V, Porteri, E, Royse, C, Ruggeri, L, Ryha, H, Silva, FS, Severi, L, Shmyrev, V, Uvaliev, N, Wang, CB, Wang, C-Y, Winterton, D, Yong, C-Y, Yu, J, Bellomo, R & Zangrillo, A 2017, 'MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design', Contemporary Clinical Trials, vol. 59, pp. 38-43. https://doi.org/10.1016/j.cct.2017.05.011

TY - JOUR

T1 - MortalitY in caRdIAc surgery (MYRIAD)

T2 - A randomizeD controlled trial of volatile anesthetics. Rationale and design

AU - Landoni, Giovanni

AU - Lomivorotov, Vladimir

AU - Pisano, Antonio

AU - Neto, Caetano Nigro

AU - Benedetto, Umberto

AU - Zoccai, Giuseppe Biondi

AU - Gemma, Marco

AU - Frassoni, Samuele

AU - Agrò, Felice Eugenio

AU - Baiocchi, Massimo

AU - Barbosa Gomes Galas, Filomena R.

AU - Bautin, Andrei

AU - Bradic, Nikola

AU - Carollo, Cristiana

AU - Crescenzi, Giuseppe

AU - Elnakera, Abeer

AU - El-Tahan, Mohamed R.

AU - Fominskiy, Evgeny

AU - Farag, Ahmed G.

AU - Gazivoda, Gordana

AU - Gianni, Stefano

AU - Grigoryev, Evgeny

AU - Guarracino, Fabio

AU - Hanafi, Sidik

AU - Huang, Weiqing

AU - Kunst, Gudrun

AU - Kunstyr, Jan

AU - Lei, Chong

AU - Lembo, Rosalba

AU - Li, Zhi-jian

AU - Likhvantsev, Valery

AU - Lozovskiy, Andrey

AU - Ma, Jun

AU - Monaco, Fabrizio

AU - Navalesi, Paolo

AU - Nazar, Bukamal

AU - Pasyuga, Vadim

AU - Porteri, Elena

AU - Royse, Colin

AU - Ruggeri, Laura

AU - Ryha, Hynek

AU - Silva, Fernanda Santos

AU - Severi, Luca

AU - Shmyrev, Vladimir

AU - Uvaliev, Nikolay

AU - Wang, Cheng Bin

AU - Wang, Chew-Yin

AU - Winterton, Dario

AU - Yong, Chow-Yen

AU - Yu, Jingui

AU - Bellomo, Rinaldo

AU - Zangrillo, Alberto

PY - 2017/5/19

Y1 - 2017/5/19

N2 - AbstractObjective 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.

AB - AbstractObjective 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.

KW - Volatile anesthetics

KW - Total intravenous anesthesia

KW - Cardiac anesthesia

KW - Cardiac surgery

KW - Randomized trial

KW - Intensive care

U2 - 10.1016/j.cct.2017.05.011

DO - 10.1016/j.cct.2017.05.011

M3 - Article (Academic Journal)

C2 - 28533194

SN - 1551-7144

VL - 59

SP - 38

EP - 43

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

ER -

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

Abstract

Keywords

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