Rationale and design of the intravenous iron for treatment of anemia before cardiac surgery trial.

Paul S Myles, Toby Richards, Andrew Klein, Julian Smith, Erica M Wood, Stephane Heritier, David McGiffin, Silva Zavarsek, Joel Symons, Zoe K McQuilten, Robert A Baker, Keyvan Karkouti, Sophia Wallace

Journal: American heart journal 2021;239():64-72

PMID: 34033804

Full Text on Elsevier Science View on PubMed

Abstract

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

Address: Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anaesthesiology and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia. Electronic address: [email protected].; Department of Anaesthesiology and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia; Department of Surgery, University of Western Australia, Perth, Western Australia, Australia.; Department of Anaesthesiology and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia; Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, United Kingdom.; Department of Cardiothoracic Surgery, Monash Health, Clayton, Victoria, Australia; Department of Surgery, Monash University, Clayton, Victoria, Australia.; Department of Clinical Haematology, Monash Health and University, Clayton, Victoria, Australia; School of Public Health and Preventive Medicine, Monash University; Melbourne, Victoria, Australia.; School of Public Health and Preventive Medicine, Monash University; Melbourne, Victoria, Australia.; Department of Cardiothoracic Surgery, Alfred Hospital, Melbourne, Victoria, Australia.; Deakin Health Economics, Institute for Health Transformation, Faculty of Health, Deakin University, Burwood, Victoria, Australia.; Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anaesthesiology and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia.; Cardiothoracic Quality and Outcomes, SALHN Perfusion Service, Flinders Medical Centre and Flinders University, Adelaide, South Australia, Australia.; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.

DOI: 10.1016/j.ahj.2021.05.008

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MeSH Terms: Administration, Intravenous, Aged, Anemia, Iron-Deficiency, Cardiac Surgical Procedures, Double-Blind Method, Elective Surgical Procedures, Female, Heart Diseases, Hematologic Agents, Hemoglobins, Humans, Iron, Male, Outcome Assessment, Health Care, Preoperative Care, Research Design, Risk Assessment