Giovanni Landoni1, Vladimir V Lomivorotov1, Caetano Nigro Neto1, Fabrizio Monaco1, Vadim V Pasyuga1, Nikola Bradic1, Rosalba Lembo1, Gordana Gazivoda1, Valery V Likhvantsev1, Chong Lei1, Andrey Lozovskiy1, Nora Di Tomasso1, Nazar A R Bukamal1, Fernanda S Silva1, Andrey E Bautin1, Jun Ma1, Martina Crivellari1, Ahmed M G A Farag1, Nikolay S Uvaliev1, Cristiana Carollo1, Marina Pieri1, Jan Kunstýř1, Chew Yin Wang1, Alessandro Belletti1, Ludhmila A Hajjar1, Evgeny V Grigoryev1, Felice E Agrò1, Hynek Riha1, Mohamed R El-Tahan1, A Mara Scandroglio1, Abeer M Elnakera1, Massimo Baiocchi1, Paolo Navalesi1, Vladimir A Shmyrev1, Luca Severi1, Mohammed A Hegazy1, Giuseppe Crescenzi1, Dmitry N Ponomarev1, Luca Brazzi1, Renato Arnoni1, Dmitry G Tarasov1, Miomir Jovic1, Maria G Calabrò1, Tiziana Bove1, Rinaldo Bellomo1, Alberto Zangrillo1. 1. From the Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute (G.L., F.M., R.L., N.D.T., M.C., M.P., A.B., A.M.S., M.G.C., A.Z.), and Vita-Salute San Raffaele University (G.L., A.Z.), Milan, Istituto di Anestesia e Rianimazione, Azienda Ospedaliera di Padova, Padua (C.C.), Anesthesia and Intensive Care Department, University Campus Bio-Medico of Rome (F.E.A.), and Anestesia e Rianimazione, Dipartimento Cardiovascolare, Azienda Ospedaliera San Camillo Forlanini (L.S.), Rome, the Department of Cardiothoracic and Vascular Anesthesia and Intensive Care, University Hospital Policlinico S. Orsola, Bologna (M.B.), Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia di Catanzaro, Catanzaro (P.N.), Anestesia e Terapia Intensiva Cardiochirurgica, Istituto Clinico Humanitas, Rozzano (G.C.), the Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, and the Department of Surgical Sciences, University of Turin, Turin (L.B.), and the Anesthesiology and Intensive Care Clinic, Department of Medicine, University of Udine, Udine (T.B.) - all in Italy; the Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk (V.V. Lomivorotov, V.A.S., D.N.P.), the Departments of Anesthesiology and Intensive Care (V.V.P.) and Cardiac Surgery (D.G.T.), Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, the Department of Anesthesia and Intensive Care, First Moscow State Medical University (V.V.P., V.V. Likhvantsev), and the Department of Intensive Care, Moscow Regional Clinical and Research Institute (V.V. Likhvantsev), Moscow, the Department of Anesthesia and Intensive Care, Ural Institute of Cardiology, Ekaterinburg (A.L.), the Laboratory for Anesthesiology and Intensive Care, Almazov National Medical Research Center, Saint Petersburg (A.E.B.), and the Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo (E.V.G.) - all in Russia; the Anesthesia Section, Department of Surgery, Dante Pazzanese Institute of Cardiology (C.N.N.), the Department of Cardiopneumology, Instituto do Coração, Universidade de São Paulo, and the Intensive Care Unit, Hospital SirioLibanes (L.A.H.), and the Cardiac Surgery Section, Department of Surgery, Dante Pazzanese Institute of Cardiology (R.A.), São Paulo, Brazil; the Department of Cardiovascular Anesthesiology and Intensive Care Medicine, and the Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Zagreb (N.B.), and the Department of Biomedical Sciences, University North, Varaždin (N.B.) - both in Croatia; the Department of Anesthesia and Intensive Care, Cardiovascular Institute Dedinje (G.G., M.J.), and the School of Medicine, University of Belgrade (M.J.), Belgrade, Serbia; the Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi (C.L.), and the Center for Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing (J.M.) - both in China; the Cardiothoracic Intensive Care Unit and Anesthesia Department, Mohammed Bin Khalifa Cardiac Center, Riffa, Bahrain (N.A.R.B.); the Department of Anesthesiology, Hospital de Santa Maria, Lisbon, Portugal (F.S.S.); the Department of Anesthesia, King Abdullah Medical City-Holy Capital, Makkah (A.M.G.A.F.), and the Anesthesiology Department, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam (M.R.E.-T.) - both in Saudi Arabia; Anesthesia and Intensive Care, Acibadem City Clinic-Cardiac Surgery Center, Burgas, Bulgaria (N.S.U.); the Department of Anesthesiology, Resuscitation and Intensive Medicine, Charles University in Prague, First Faculty of Medicine and General Teaching Hospital (J.K.), and the Cardiothoracic Anesthesiology and Intensive Care, Department of Anesthesiology and Intensive Care Medicine, Institute for Clinical and Experimental Medicine (H.R.), Prague, Czech Republic; the Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.); the Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University Hospitals, Zagazig (A.M.E.), and the Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura (M.A.H.) - both in Egypt; and the School of Medicine, University of Melbourne, Melbourne, VIC, Australia (R.B.).
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. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
RCT Entities:
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. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
Authors: Adam S Evans; Menachem M Weiner; Shahzad Shaefi; Prakash A Patel; Matthew M Townsley; Abirami Kumaresan; Jared W Feinman; Ashley V Fritz; Archer K Martin; Toby B Steinberg; J Ross Renew; Jane L Gui; Brian Radvansky; Himani Bhatt; Sudhakar Subramani; Archit Sharma; Jacob T Gutsche; John G Augoustides; Harish Ramakrishna Journal: J Cardiothorac Vasc Anesth Date: 2019-11-09 Impact factor: 2.628
Authors: Roger G Evans; Naoya Iguchi; Andrew D Cochrane; Bruno Marino; Sally G Hood; Rinaldo Bellomo; Peter R McCall; Clive N May; Yugeesh R Lankadeva Journal: Am J Physiol Regul Integr Comp Physiol Date: 2019-12-11 Impact factor: 3.619