Emmanuelle Duceppe1, Salim Yusuf2, Vikas Tandon3, Reitze Rodseth4, Bruce M Biccard5, Denis Xavier6, Wojciech Szczeklik7, Christian S Meyhoff8, Maria Grazia Franzosi9, Jessica Vincent10, Sadeesh K Srinathan11, Joel Parlow12, Patrick Magloire3, John Neary3, Mangala Rao6, Navneet K Chaudhry13, Bongani Mayosi14, Miriam de Nadal15, Ekaterine Popova16, Juan Carlos Villar17, Fernando Botto18, Otavio Berwanger19, Gordon Guyatt20, John W Eikelboom3, Daniel I Sessler21, Clive Kearon3, Shirley Pettit10, Stuart J Connolly2, Mukul Sharma2, Shrikant I Bangdiwala22, P J Devereaux23. 1. McMaster University, Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada; University of Montreal, Department of Medicine, Montreal, Quebec, Canada. 2. Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Department of Medicine, Hamilton, Ontario, Canada. 3. McMaster University, Department of Medicine, Hamilton, Ontario, Canada. 4. University of KwaZulu-Natal, Department of Anaesthesia, Pietermaritzburg, South Africa. 5. Groote Schuur Hospital and University of Cape Town, Department of Anaesthesia and Perioperative Medicine, Cape Town, South Africa. 6. St John's Medical College and Research Institute, Department of Pharmacology, Bangalore, India. 7. Jagiellonian University Medical College, Department of Intensive Care and Perioperative Medicine, Krakow, Poland. 8. Bispebjerg and Frederiksberg Hospital, Department of Anaesthesia and Intensive Care, University of Copenhagen, Copenhagen, Denmark. 9. IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Department of Cardiovascular Research, Milan, Italy. 10. Population Health Research Institute, Hamilton, Ontario, Canada. 11. University of Manitoba, Department of Surgery, Winnipeg, Manitoba, Canada. 12. Queen's University, Department of Anesthesiology and Perioperative Medicine, Kingston, Ontario, Canada. 13. Christian Medical College Hospital, Department of Surgery, Ludhiana, India. 14. Groote Schuur Hospital and University of Cape Town, Department of Medicine, Cape Town, South Africa. 15. Hospital Universitari Vall d'Hebron, Department of Anesthesiology, Barcelona, Spain. 16. Hospital de la Santa Creu i Sant Pau, Clinical Epidemiology and Public Health Service, Barcelona, Spain. 17. Departamento de Investigaciones, Fundación Cardioinfantil - Instituto de Cardiología, (Bogotá) and Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia. 18. Estudios Clínicos Latinoamérica, Rosario and Hospital Austral, Pilar, Argentina. 19. Instituto de Ensino e Pesquisa do Hospital do Coração, Sao Paulo, Brazil. 20. McMaster University, Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada; McMaster University, Department of Medicine, Hamilton, Ontario, Canada. 21. Cleveland Clinic, Department of Outcomes Research, Cleveland, Ohio, USA. 22. McMaster University, Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. 23. McMaster University, Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Department of Medicine, Hamilton, Ontario, Canada. Electronic address: philipj@mcmaster.ca.
Abstract
BACKGROUND:Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. METHODS: The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. RESULTS: The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. CONCLUSION: MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS.
RCT Entities:
BACKGROUND: Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. METHODS: The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. RESULTS: The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. CONCLUSION: MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS.
Authors: Nathaniel R Smilowitz; Gabriel Redel-Traub; Anais Hausvater; Andrew Armanious; Joseph Nicholson; Christian Puelacher; Jeffrey S Berger Journal: Cardiol Rev Date: 2019 Nov/Dec Impact factor: 2.644
Authors: Flavia K Borges; Tej Sheth; Ameen Patel; Maura Marcucci; Terence Yung; Thomas Langer; Carolina Alboim; Carisi Anne Polanczyk; Federico Germini; Andre Ferreira Azeredo-da-Silva; Erin Sloan; Kendeep Kaila; Ron Ree; Alessandra Bertoletti; Maria Cristina Vedovati; Antonio Galzerano; Jessica Spence; P J Devereaux Journal: CJC Open Date: 2020-07-17
Authors: Giovanna Lurati Buse; Braden Manns; Andre Lamy; Gordon Guyatt; Carisi A Polanczyk; Matthew T V Chan; Chew Yin Wang; Juan Carlos Villar; Alben Sigamani; Daniel I Sessler; Otavio Berwanger; Bruce M Biccard; Rupert Pearse; Gerard Urrútia; Wojciech Szczeklik; Ignacio Garutti; Sadeesh Srinathan; German Malaga; Valsa Abraham; Clara K Chow; Michael J Jacka; Maria Tiboni; Gareth Ackland; Danielle Macneil; Robert Sapsford; Martin Leuwer; Yannick Le Manach; Philip J Devereaux Journal: Can J Surg Date: 2018-06 Impact factor: 2.089