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

Landoni G 1 , Lomivorotov V 2 , Pisano A 3 , Nigro Neto C 4 , Benedetto U 5 , Biondi Zoccai G 6 Show all authors , Gemma M 7 , Frassoni S 7 , Agrò FE 8 , Baiocchi M 9 , Barbosa Gomes Galas FR 10 , Bautin A 11 , Bradic N 12 , Carollo C 13 , Crescenzi G 14 , Elnakera AM 15 , El-Tahan MR 16 , Fominskiy E 17 , Farag AG 18 , Gazivoda G 19 , Gianni S 7 , Grigoryev E 20 , Guarracino F 21 , Hanafi S 22 , Huang W 23 , Kunst G 24 , Kunstyr J 25 , Lei C 26 , Lembo R 7 , Li ZJ 27 , Likhvantsev V 28 , Lozovskiy A 29 , Ma J 30 , Monaco F 7 , Navalesi P 31 , Nazar B 32 , Pasyuga V 33 , Porteri E 34 , Royse C 35 , Ruggeri L 7 , Riha H 36 , Santos Silva F 37 , Severi L 38 , Shmyrev V 2 , Uvaliev N 39 , Wang CB 30 , Wang CY 40 , Winterton D 7 , Yong CY 41 , Yu J 42 , Bellomo R 43 , Zangrillo A 7

Affiliations 

  • 1 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, Milan 20132, Italy. Electronic address: [email protected]
  • 2 Siberian Biomedical Research Center, Department of Anesthesiology and Intensive Care, Novosibirsk, Russia
  • 3 Cardiac Anesthesia and Intensive Care Unit, Monaldi Hospital A.O.R.N. "Dei Colli", Via L. Bianchi Naples, 80131, Italy
  • 4 Anesthesia Section of Cardiothoracic Surgery, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil
  • 5 University of Bristol, School of Clinical Sciences, Bristol Heart Institute, Bristol, United Kingdom
  • 6 Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy
  • 7 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, Milan 20132, Italy
  • 8 Anaesthesia, Intensive Care and Pain Management Department, University School of Medicine Campus Bio-Medico, Rome, Italy
  • 9 Anesthesia and Intensive Care, S. Orsola-Malpighi University Hospital, Bologna, Italy
  • 10 Anesthesia and Intensive care, Heart Institute, University of Sao Paulo, Sao Paulo, Brazil
  • 11 Department of Anesthesiology and Intensive Care, Federal Almazov North-West Medical Research Centre, Saint-Petersburg, Russia
  • 12 Department of Cardiovascular Anesthesiology and Cardiac Intensive Medicine, University Hospital Dubrava, Zagreb, Croatia
  • 13 Department of Medicine, Anesthesia and Intensive Care Unit, Padova University Hospital, Via Cesare Battisti 256, 35128 Padova, Italy
  • 14 Anestesia e Terapia Intensiva Cardiochirurgica, Humanitas Research Hospital, Rozzano, Italy
  • 15 Anesthesia and Intensive Care, Faculty of Medicine, Zagazig University, Zagazig, Egypt
  • 16 Cardiothoracic Anaesthesia & Surgical Intensive Care, King Fahd Hospital, University of Dammam, Al Khobar, Saudi Arabia
  • 17 Department of Anaesthesia and Intensive Care, Siberian Biomedical Research Center of the Ministry of Health, Novosibirsk, Russia
  • 18 Department of Anaesthesia and Intensive Care, King Abdullah Medical City in Holy Capital "KAMC-HC", Makkah, Saudi Arabia
  • 19 Department of Anesthesiology and Intensive Care, Cardiovascular Institute `Dedinje`, Belgrade, Serbia
  • 20 Deputy Director for Clinical and Scientific Affairs, Scientific Research Institute of Complex Issues of Cardiovascular Disease, Kemerovo, Russia
  • 21 Department of Anaesthesia and Critical Care Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa 2, 56123 Pisa, Italy
  • 22 Department of Anaesthesiology and Intensive Care, Sarawak General Hospital, Kuching, Sarawak, Malaysia
  • 23 Department of Anesthesiology, Wuhan Asia Heart Hospital, Wuhan, China
  • 24 Department of Anaesthetics, King's College Hospital NHS Foundation Trust, London, United Kingdom
  • 25 Department of Anesthesiology and Intensive Care, First Faculty of Medicine, General University Hospital in Prague, Prague, Czech Republic
  • 26 Department of Anesthesiology and Perioperative Medicine, 1st Affiliative Hospital (Xijing Hospital), Fourth Military Medical University, Xi'an, China
  • 27 Department of Anesthesiology, The Second Xiangya Hospital of Central South University, Changsha, China
  • 28 Anesthesiology and Intensive Care Department, Moscow Clinical Regional Research Institute, Shepkina st., 61/2, Moscow, Russia
  • 29 Department of Anesthesiology and Intensive Care, Ural Institute of Cardiology, Ekaterinburg, Russia
  • 30 Center for Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
  • 31 Anesthesia and Intensive Care, Dipartimento Scienze Mediche e Chirurgiche, Università della Magna Graecia, Catanzaro, Italy
  • 32 Cardiothoracic ICU and Anaesthesia, MKCC, West Riffa, Bahrain
  • 33 Department of Cardiac Aneasthesia and Intensive Care, Astrakhan Federal Centre for Cardiac Surgery, Astrakhan, Russia
  • 34 Dipartimento Cardiotoracico, Azienda Ospedaliera Spedali Civili, Brescia, Italy
  • 35 Department of Surgery, Level 6 Clinical Medical Research Building, The University of Melbourne, Melbourne, Australia
  • 36 Cardiothoracic Anesthesiology and Intensive Care, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
  • 37 Anesthetic Department, Hospital de Santa Maria, Lisboa, Portugal
  • 38 Anesthesia and Intensive Care, Azienda Ospedaliera San Camillo Forlanini, Roma,Italy
  • 39 Department-Anesthesia and Intensive Care, ACIBADEM City Clinic Burgas, Burgas, Bulgaria
  • 40 Anaesthesia and Intensive Care, University of Malaya, Kuala Lumpur, Malaysia
  • 41 Anaesthesia and Intensive Care, Hospital Pulau Pinang, Georgetown, Malaysia
  • 42 Department of Anesthesiology, Qilu Hospital of Shandong University, Shandong, China
  • 43 The University of Melbourne, Melbourne, Victoria, Australia
Contemp Clin Trials, 2017 08;59:38-43.
PMID: 28533194 DOI: 10.1016/j.cct.2017.05.011

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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