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

Fingerprint

Thoracic Surgery
Anesthetics
Randomized Controlled Trials
Mortality
Coronary Artery Bypass
Transplants
Intravenous Anesthesia
Troponin I
Survival
Tertiary Care Centers
Sample Size
Intensive Care Units
Length of Stay
Hospitalization
Myocardial Infarction
Incidence

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

Cite this

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

In: Contemporary Clinical Trials, Vol. 59, 2017, p. 38-43.

Research output: Contribution to journalArticle

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, 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, CB, Wang, C-Y, Winterton, D, Yong, C-Y & 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
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. ; 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. ; Zangrillo, A. / MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design. In: Contemporary Clinical Trials. 2017 ; Vol. 59. pp. 38-43.
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title = "MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design",
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. {\circledC} 2017 Elsevier Inc.",
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",
author = "G. Landoni and V. Lomivorotov and A. Pisano and {Nigro Neto}, C. and U. Benedetto and {Biondi Zoccai}, G. and M. Gemma and S. Frassoni and F.E. Agr{\`o} and M. Baiocchi and {Barbosa Gomes Galas}, F.R. and A. Bautin and N. Bradic and C. Carollo and G. Crescenzi and A.M. Elnakera and M.R. El-Tahan and E. Fominskiy and A.G. Farag and G. Gazivoda and S. Gianni and E. Grigoryev and F. Guarracino and S. Hanafi and W. Huang and G. Kunst and J. Kunstyr and C. Lei and R. Lembo and Z.-J. Li and V. Likhvantsev and A. Lozovskiy and J. Ma and F. Monaco and P. Navalesi and B. Nazar and V. Pasyuga and E. Porteri and C. Royse and L. Ruggeri and H. Riha and {Santos Silva}, F. and L. Severi and V. Shmyrev and N. Uvaliev and C.B. Wang and C.-Y. Wang and D. Winterton and C.-Y. Yong and A. Zangrillo",
note = "Export Date: 2 March 2018 Correspondence Address: Landoni, G.; Department of Anesthesia and Intensive Care, San Raffaele Hospital, Via Olgettina 60 Milan, Italy; email: landoni.giovanni@hsr.it Chemicals/CAS: desflurane, 57041-67-5; fentanyl, 437-38-7; isoflurane, 26675-46-7; midazolam, 59467-70-8; propofol, 2078-54-8; remifentanil, 132539-07-2; sevoflurane, 28523-86-6; sufentanil, 56030-54-7 References: Mozaffarian, D., Benjamin, E.J., Go, A.S., Heart disease and stroke statistics—2015 update a report from the American Heart Association (2015) Circulation, 131, p. 00; Landoni, G., Augoustides, J.G., Guarracino, F., Mortality reduction in cardiac anesthesia and intensive care: results of the first International Consensus Conference (2011) HSR Proc. Intensive Care Cardiovasc. Anesth., 3 (1), pp. 9-19; Ross, S., Protective effects of anaesthetics in reversible and irreversible ischaemia-reperfusion injury (1999) Br. J. Anaesth., 82, pp. 622-632; Kunst, G., Klein, A.A., Peri-operative anaesthetic myocardial preconditioning and protection - cellular mechanisms and clinical relevance in cardiac anaesthesia (2015) Anaesthesia, 70 (4), pp. 467-482. , Apr; Fortis, S., Spieth, P.M., Lu, W.Y., Effects of anesthetic regimes on inflammatory responses in a rat model of acute lung injury (2012) Intensive Care Med., 38 (9), pp. 1548-1555. , Sep; Schilling, T., Kozian, A., Senturk, M., Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients (2011) Anesthesiology, 115 (1), pp. 65-74. , Jul; Yang, Q., Dong, H., Deng, J., Sevoflurane preconditioning induces neuroprotection through reactive oxygen species-mediated up-regulation of antioxidant enzymes in rats (2011) Anesth. Analg., 112 (4), pp. 931-937. , Apr; Beck-Schimmer, B., Breitenstein, S., Bonvini, J.M., Protection of pharmacological postconditioning in liver surgery: results of a prospective randomized controlled trial (2012) Ann. Surg., 256 (5), pp. 837-844. , Nov; Lee, H.T., Kim, M., Kim, J., Kim, N., Emala, C.W., TGF-beta1 release by volatile anesthetics mediates protection against renal proximal tubule cell necrosis (2007) Am. J. Nephrol., 27 (4), pp. 416-424; Uhlig, C., Bluth, T., Schwarz, K., Effects of volatile anesthetics on mortality and postoperative pulmonary and other complications in patients undergoing surgery: a systematic review and meta-analysis (2016) Anesthesiology, 124 (6), pp. 1230-1245. , Jun; De Hert, S., A comparison of volatile and non-volatile agents for cardioprotection during on-pump coronary surgery (2009) Anaesthesia, 64, pp. 953-960; Likhvantsev, V.V., Landoni, G., Levikov, D.I., Grebenchikov, O.A., Sevoflurane versus total intravenous anesthesia for isolated coronary artery bypass surgery with cardiopulmonary bypass: a randomized trial (2016) J. Cardiothorac. Vasc. Anesth., 30 (5), pp. 1221-1227. , Oct; Khuri, S.F., Henderson, W.G., DePalma, R.G., Determinants of long-term survival after major surgery and the adverse effect of postoperative complications (2005) Ann. Surg., 242 (3), pp. 326-341. , Sep; Rhodes, A., Cecconi, M., Hamilton, M., Goal-directed therapy in high-risk surgical patients: a 15-year follow-up study (2010) Intensive Care Med., 36 (8), pp. 1327-1332. , Aug; Serruys, P.W., Morice, M.C., Kappetein, A.P., SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease (2009) N. Engl. J. Med., 360 (10), pp. 961-972; Park, S.J., Ahn, J.M., Kim, Y.H., Trial of everolimus-eluting stents or bypass surgery for coronary disease (2015) N. Engl. J. Med., 372 (13), pp. 1204-1212. , Mar 26; Kapur, A., Hall, R.J., Malik, I.S., Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial (2010) J. Am. Coll. Cardiol., 55 (5), pp. 432-440. , Feb 2; Farkouh, M.E., Domanski, M., Sleeper, L.A., Strategies for multivessel revascularization in patients with diabetes (2012) N. Engl. J. Med., 367 (25), pp. 2375-2384. , Dec 20; Shroyer, A.L., Grover, F.L., Hattler, B., On-pump versus off-pump coronary-artery bypass surgery (2009) N. Engl. J. Med., 361 (19), pp. 1827-1837. , Nov 5; Landoni, G., Greco, T., Biondi-Zoccai, G., Anaesthetic drugs and survival: a Bayesian network meta-analysis of randomized trials in cardiac surgery (2013) Br. J. Anaesth., 111 (6), pp. 886-896; Jakobsen, C.J., Berg, H., Hindsholm, K.B., Faddy, N., Sloth, E., The influence of propofol versus sevoflurane anesthesia on outcome in 10,535 cardiac surgical procedures (2007) J. Cardiothorac. Vasc. Anesth., 21 (5), pp. 664-671. , Oct; Andrews, D.T., Royse, C., Royse, A.G., The mitochondrial permeability transition pore and its role in anaesthesia-triggered cellular protection during ischaemia-reperfusion injury (2012) Anaesth. Intensive Care, 40 (1), pp. 46-70. , Jan; Muntean, D.M., Volatile anaesthetics and cardioprotection - lessons from animal studies (2013) Fundam. Clin. Pharmacol., 27, pp. 21-34; Lange, M., Desflurane-induced preconditioning has a threshold that is lowered by repetitive application and is mediated by beta 2-adrenergic receptors (2009) J. Cardiothorac. Vasc. Anesth., 23, pp. 607-613; Vierron, E., Giraudeau, B., Sample size calculation for multicenter randomized trial: taking the center effect into account (2007) Contemp. Clin. Trials, 28 (4), pp. 451-458; De Mets, D.L., Pocock, S.J., Julian, D.G., The agonising negative trend in monitoring of clinical trials (1999) Lancet, 354, pp. 1983-1988; O'Brien, P.C., Fleming, T.R., A multiple testing procedure for clinical trials., 35, pp. 549-556. , “” Biometrics, pages; Guarracino, F., Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study (2006) J. Cardiothorac. Vasc. Anesth., 20 (4), pp. 477-483; Wang, J., Sevoflurane at 1 MAC provides optimal myocardial protection during off-pump CABG (2013) Scand. Cardiovasc. J., 47 (3), pp. 175-184; Tempe, D.K., Myocardial protection with isoflurane during off-pump coronary artery bypass grafting: a randomized trial (2011) J. Cardiothorac. Vasc. Anesth., 25 (1), pp. 59-65; Guerrero Orriach, J.L., Prolonged sevoflurane administration in the off-pump coronary artery bypass graft surgery: beneficial effects (2013) J. Crit. Care, 28 (5)",
year = "2017",
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.",

}

TY - JOUR

T1 - MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design

AU - Landoni, G.

AU - Lomivorotov, V.

AU - Pisano, A.

AU - Nigro Neto, C.

AU - Benedetto, U.

AU - Biondi Zoccai, G.

AU - Gemma, M.

AU - Frassoni, S.

AU - Agrò, F.E.

AU - Baiocchi, M.

AU - Barbosa Gomes Galas, F.R.

AU - Bautin, A.

AU - Bradic, N.

AU - Carollo, C.

AU - Crescenzi, G.

AU - Elnakera, A.M.

AU - El-Tahan, M.R.

AU - Fominskiy, E.

AU - Farag, A.G.

AU - Gazivoda, G.

AU - Gianni, S.

AU - Grigoryev, E.

AU - Guarracino, F.

AU - Hanafi, S.

AU - Huang, W.

AU - Kunst, G.

AU - Kunstyr, J.

AU - Lei, C.

AU - Lembo, R.

AU - Li, Z.-J.

AU - Likhvantsev, V.

AU - Lozovskiy, A.

AU - Ma, J.

AU - Monaco, F.

AU - Navalesi, P.

AU - Nazar, B.

AU - Pasyuga, V.

AU - Porteri, E.

AU - Royse, C.

AU - Ruggeri, L.

AU - Riha, H.

AU - Santos Silva, F.

AU - Severi, L.

AU - Shmyrev, V.

AU - Uvaliev, N.

AU - Wang, C.B.

AU - Wang, C.-Y.

AU - Winterton, D.

AU - Yong, C.-Y.

AU - Zangrillo, A.

N1 - Export Date: 2 March 2018 Correspondence Address: Landoni, G.; Department of Anesthesia and Intensive Care, San Raffaele Hospital, Via Olgettina 60 Milan, Italy; email: landoni.giovanni@hsr.it Chemicals/CAS: desflurane, 57041-67-5; fentanyl, 437-38-7; isoflurane, 26675-46-7; midazolam, 59467-70-8; propofol, 2078-54-8; remifentanil, 132539-07-2; sevoflurane, 28523-86-6; sufentanil, 56030-54-7 References: Mozaffarian, D., Benjamin, E.J., Go, A.S., Heart disease and stroke statistics—2015 update a report from the American Heart Association (2015) Circulation, 131, p. 00; Landoni, G., Augoustides, J.G., Guarracino, F., Mortality reduction in cardiac anesthesia and intensive care: results of the first International Consensus Conference (2011) HSR Proc. Intensive Care Cardiovasc. Anesth., 3 (1), pp. 9-19; Ross, S., Protective effects of anaesthetics in reversible and irreversible ischaemia-reperfusion injury (1999) Br. J. Anaesth., 82, pp. 622-632; Kunst, G., Klein, A.A., Peri-operative anaesthetic myocardial preconditioning and protection - cellular mechanisms and clinical relevance in cardiac anaesthesia (2015) Anaesthesia, 70 (4), pp. 467-482. , Apr; Fortis, S., Spieth, P.M., Lu, W.Y., Effects of anesthetic regimes on inflammatory responses in a rat model of acute lung injury (2012) Intensive Care Med., 38 (9), pp. 1548-1555. , Sep; Schilling, T., Kozian, A., Senturk, M., Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients (2011) Anesthesiology, 115 (1), pp. 65-74. , Jul; Yang, Q., Dong, H., Deng, J., Sevoflurane preconditioning induces neuroprotection through reactive oxygen species-mediated up-regulation of antioxidant enzymes in rats (2011) Anesth. Analg., 112 (4), pp. 931-937. , Apr; Beck-Schimmer, B., Breitenstein, S., Bonvini, J.M., Protection of pharmacological postconditioning in liver surgery: results of a prospective randomized controlled trial (2012) Ann. Surg., 256 (5), pp. 837-844. , Nov; Lee, H.T., Kim, M., Kim, J., Kim, N., Emala, C.W., TGF-beta1 release by volatile anesthetics mediates protection against renal proximal tubule cell necrosis (2007) Am. J. Nephrol., 27 (4), pp. 416-424; Uhlig, C., Bluth, T., Schwarz, K., Effects of volatile anesthetics on mortality and postoperative pulmonary and other complications in patients undergoing surgery: a systematic review and meta-analysis (2016) Anesthesiology, 124 (6), pp. 1230-1245. , Jun; De Hert, S., A comparison of volatile and non-volatile agents for cardioprotection during on-pump coronary surgery (2009) Anaesthesia, 64, pp. 953-960; Likhvantsev, V.V., Landoni, G., Levikov, D.I., Grebenchikov, O.A., Sevoflurane versus total intravenous anesthesia for isolated coronary artery bypass surgery with cardiopulmonary bypass: a randomized trial (2016) J. Cardiothorac. Vasc. Anesth., 30 (5), pp. 1221-1227. , Oct; Khuri, S.F., Henderson, W.G., DePalma, R.G., Determinants of long-term survival after major surgery and the adverse effect of postoperative complications (2005) Ann. Surg., 242 (3), pp. 326-341. , Sep; Rhodes, A., Cecconi, M., Hamilton, M., Goal-directed therapy in high-risk surgical patients: a 15-year follow-up study (2010) Intensive Care Med., 36 (8), pp. 1327-1332. , Aug; Serruys, P.W., Morice, M.C., Kappetein, A.P., SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease (2009) N. Engl. J. Med., 360 (10), pp. 961-972; Park, S.J., Ahn, J.M., Kim, Y.H., Trial of everolimus-eluting stents or bypass surgery for coronary disease (2015) N. Engl. J. Med., 372 (13), pp. 1204-1212. , Mar 26; Kapur, A., Hall, R.J., Malik, I.S., Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial (2010) J. Am. Coll. Cardiol., 55 (5), pp. 432-440. , Feb 2; Farkouh, M.E., Domanski, M., Sleeper, L.A., Strategies for multivessel revascularization in patients with diabetes (2012) N. Engl. J. Med., 367 (25), pp. 2375-2384. , Dec 20; Shroyer, A.L., Grover, F.L., Hattler, B., On-pump versus off-pump coronary-artery bypass surgery (2009) N. Engl. J. Med., 361 (19), pp. 1827-1837. , Nov 5; Landoni, G., Greco, T., Biondi-Zoccai, G., Anaesthetic drugs and survival: a Bayesian network meta-analysis of randomized trials in cardiac surgery (2013) Br. J. Anaesth., 111 (6), pp. 886-896; Jakobsen, C.J., Berg, H., Hindsholm, K.B., Faddy, N., Sloth, E., The influence of propofol versus sevoflurane anesthesia on outcome in 10,535 cardiac surgical procedures (2007) J. Cardiothorac. Vasc. Anesth., 21 (5), pp. 664-671. , Oct; Andrews, D.T., Royse, C., Royse, A.G., The mitochondrial permeability transition pore and its role in anaesthesia-triggered cellular protection during ischaemia-reperfusion injury (2012) Anaesth. Intensive Care, 40 (1), pp. 46-70. , Jan; Muntean, D.M., Volatile anaesthetics and cardioprotection - lessons from animal studies (2013) Fundam. Clin. Pharmacol., 27, pp. 21-34; Lange, M., Desflurane-induced preconditioning has a threshold that is lowered by repetitive application and is mediated by beta 2-adrenergic receptors (2009) J. Cardiothorac. Vasc. Anesth., 23, pp. 607-613; Vierron, E., Giraudeau, B., Sample size calculation for multicenter randomized trial: taking the center effect into account (2007) Contemp. Clin. Trials, 28 (4), pp. 451-458; De Mets, D.L., Pocock, S.J., Julian, D.G., The agonising negative trend in monitoring of clinical trials (1999) Lancet, 354, pp. 1983-1988; O'Brien, P.C., Fleming, T.R., A multiple testing procedure for clinical trials., 35, pp. 549-556. , “” Biometrics, pages; Guarracino, F., Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study (2006) J. Cardiothorac. Vasc. Anesth., 20 (4), pp. 477-483; Wang, J., Sevoflurane at 1 MAC provides optimal myocardial protection during off-pump CABG (2013) Scand. Cardiovasc. J., 47 (3), pp. 175-184; Tempe, D.K., Myocardial protection with isoflurane during off-pump coronary artery bypass grafting: a randomized trial (2011) J. Cardiothorac. Vasc. Anesth., 25 (1), pp. 59-65; Guerrero Orriach, J.L., Prolonged sevoflurane administration in the off-pump coronary artery bypass graft surgery: beneficial effects (2013) J. Crit. Care, 28 (5)

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - Cardiac anesthesia

KW - Cardiac surgery

KW - Intensive care

KW - Randomized trial

KW - Total intravenous anesthesia

KW - Volatile anesthetics

KW - desflurane

KW - fentanyl

KW - isoflurane

KW - midazolam

KW - propofol

KW - remifentanil

KW - sevoflurane

KW - sufentanil

KW - adult

KW - Article

KW - cardiopulmonary bypass

KW - cardiovascular mortality

KW - clinical outcome

KW - controlled study

KW - coronary artery bypass graft

KW - follow up

KW - heart infarction

KW - human

KW - hypothesis

KW - inhalation anesthesia

KW - intensive care unit

KW - intravenous anesthesia

KW - major clinical study

KW - multicenter study

KW - postoperative period

KW - randomized controlled trial

KW - sample size

KW - single blind procedure

KW - study design

U2 - 10.1016/j.cct.2017.05.011

DO - 10.1016/j.cct.2017.05.011

M3 - Article

VL - 59

SP - 38

EP - 43

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

ER -