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

Author

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

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.

Published
2017

2. Volatile Anesthetics versus Total Intravenous Anesthesia for Cardiac Surgery.

Author

Monaco, F., Lembo, R., Di Tomasso, N., Crivellari, M., Pieri, M., Beiletti, A., Scandroglio, A. M., Calabrò, M. G., Zangrillo, A., Landoni, G., Lei, C., Lozovskiy, A., Bukamal, N. A. R., Silva, F. S., Bautin, A. E., Ma, J., Farag, A. M. G. A., Uvaliev, N. S., Carollo, C., and Kunstýř, J.

Abstract

BACKGROUND Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P=0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. [ABSTRACT FROM AUTHOR]

Published
2019
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3. MortalitY in caRdIAc surgery (MYRIAD):A randomizeD controlled trial of volatile anesthetics. Rationale and design

Author

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

Subjects
Adult, Male, Total intravenous anesthesia, Coronary Artery Disease, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, law, Intensive care, medicine, Clinical endpoint, Anesthesia, Cardiac Procedures, Humans, Pharmacology (medical), 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, Cardiac anesthesia, Cardiac surgery, Randomized trial, Volatile anesthetics, business.industry, Coronary Artery Bypa, Medicine (all), General Medicine, medicine.disease, Intensive care unit, Survival Analysis, Volatile anesthetic, Outcome and Process Assessment, Health Care, Intravenous anesthesia, Anesthesia, Anesthetic, Anesthetics, Inhalation, Female, Survival Analysi, Volatilization, business, Anesthesia, Cardiac Procedure, Human, medicine.drug
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.

Published
2017

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

Author

Landoni G, Lomivorotov V, Pisano A, Nigro Neto C, Benedetto U, Biondi Zoccai G, Gemma M, Frassoni S, Agrò FE, Baiocchi M, Barbosa Gomes Galas FR, Bautin A, Bradic N, Carollo C, Crescenzi G, Elnakera AM, 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 ZJ, Likhvantsev V, Lozovskiy A, Ma J, Monaco F, Navalesi P, Nazar B, Pasyuga V, Porteri E, Royse C, Ruggeri L, Riha H, Santos Silva F, Severi L, Shmyrev V, Uvaliev N, Wang CB, Wang CY, Winterton D, Yong CY, Yu J, Bellomo R, and Zangrillo A

Subjects
Adult, Coronary Artery Disease mortality, Female, Humans, Male, Outcome and Process Assessment, Health Care, Survival Analysis, Volatilization, Anesthesia, Cardiac Procedures adverse effects, Anesthesia, Cardiac Procedures methods, Anesthetics, Inhalation administration & dosage, Anesthetics, Inhalation chemistry, Coronary Artery Bypass adverse effects, Coronary Artery Bypass methods, Coronary Artery Bypass mortality, Coronary Artery Disease surgery, Postoperative Complications etiology, Postoperative Complications prevention & control
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 30day 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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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