Paul S Myles1, Julian A Smith2, Jessica Kasza3, Brendan Silbert4, Mohandas Jayarajah5, Thomas Painter6, D James Cooper7, Silvana Marasco7, John McNeil3, Jean S Bussières8, Shay McGuinness9, Kelly Byrne10, Matthew T V Chan11, Giovanni Landoni12, Sophie Wallace7, Andrew Forbes3. 1. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne, Australia; Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Australia. Electronic address: p.myles@alfred.org.au. 2. Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Australia; Department of Cardiothoracic Surgery, Monash Medical Centre, Clayton, Australia. 3. Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Australia. 4. Department of Anaesthesia, St Vincent's Hospital, Fitzroy, Australia. 5. Department of Cardiothoracic Anaesthesia and Cardiac Critical Care, South West Cardiac Centre, Derriford Hospital, Plymouth, United Kingdom. 6. Royal Adelaide Hospital and Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia. 7. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne, Australia; Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Australia. 8. Department of Anesthesiology, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Quebec, Canada. 9. Department of Cardiothoracic & Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand. 10. Department of Anaesthesia, Waikato Hospital, New Zealand. 11. Department of Anesthesiology and Intensive Care, The Chinese University of Hong Kong, Hong Kong, China. 12. Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy.
Abstract
BACKGROUND:Tranexamic acid reduces blood loss and transfusion requirements in cardiac surgery but may increase the risk of coronary graft thrombosis. We previously reported the 30-day results of a trial evaluating tranexamic acid for coronary artery surgery. Here we report the 1-year clinical outcomes. METHODS: Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receiveaspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score of less than 8. Secondary outcomes included a composite of myocardial infarction, stroke, and death from any cause through to 1 year after surgery. RESULTS: The rate of death or disability at 1 year was 3.8% in the tranexamic acid group and 4.4% in the placebo group (relative risk, 0.85; 95% confidence interval, 0.64-1.13; P = .27), and this did not significantly differ according to aspirin exposure at the time of surgery (interaction P = .073). The composite rate of myocardial infarction, stroke, and death up to 1 year after surgery was 14.3% in the tranexamic acid group and 16.4% in the placebo group (relative risk, 0.87; 95% CI, 0.76-1.00; P = .053). CONCLUSIONS: In this trial of patients having coronary artery surgery, tranexamic acid did not affect death or severe disability through to 1 year after surgery. Further work should be done to explore possible beneficial effects on late cardiovascular events.
RCT Entities:
BACKGROUND:Tranexamic acid reduces blood loss and transfusion requirements in cardiac surgery but may increase the risk of coronary graft thrombosis. We previously reported the 30-day results of a trial evaluating tranexamic acid for coronary artery surgery. Here we report the 1-year clinical outcomes. METHODS: Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score of less than 8. Secondary outcomes included a composite of myocardial infarction, stroke, and death from any cause through to 1 year after surgery. RESULTS: The rate of death or disability at 1 year was 3.8% in the tranexamic acid group and 4.4% in the placebo group (relative risk, 0.85; 95% confidence interval, 0.64-1.13; P = .27), and this did not significantly differ according to aspirin exposure at the time of surgery (interaction P = .073). The composite rate of myocardial infarction, stroke, and death up to 1 year after surgery was 14.3% in the tranexamic acid group and 16.4% in the placebo group (relative risk, 0.87; 95% CI, 0.76-1.00; P = .053). CONCLUSIONS: In this trial of patients having coronary artery surgery, tranexamic acid did not affect death or severe disability through to 1 year after surgery. Further work should be done to explore possible beneficial effects on late cardiovascular events.
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28
Authors: Fiona Nemeh; Rachelle Buchbinder; Carmel M Hawley; Mark R Nelson; Jacqui G Waterkeyn; Christopher M Reid Journal: Trials Date: 2022-01-28 Impact factor: 2.279