An international trial, published The New England Journal of Medicine, concludes that the administration of tranexamic acid in patients with cardiovascular risk in patients undergoing non-cardiac surgery significantly reduces the risk of major bleeding without increasing major vascular complications. These findings may result not only into clinical benefits for patients but also into global benefits for health systems and public health, by drastically reducing the number of necessary transfusions.
Bleeding is a common problem in patients undergoing non-cardiac surgery, which often require blood transfusions. Now, an international multicentre study coordinated at Spanish level by researchers from the Research Institute of the Hospital de la Santa Creu i Sant Pau – IIB Sant Pau, shows that the administration of tranexamic acid could prevent this problem. The results of the study have just been published in the prestigious journal The New England Journal of Medicine.
The study, led by Dr. Devereaux of the Population Health Research Institute, the McMaster University and the Hamilton Health Sciences (HHS) in Canada, included participation of 114 hospitals in 22 different countries. Dr. Mª José Martínez, Miquel Servet II researcher from the Clinical Epidemiology and Healthcare Services group at IIB Sant Pau, has coordinated the project in Spain and Dr. Pilar Paniagua, from the Anaesthesiology and Resuscitation Service and the Anesthesiology research group, has been the principal investigator at the Hospital de la Santa Creu i Sant Pau. Other members of the Anaesthesiology and Nursing services, as well as members of the Pharmacy, Cardiology, Orthopaedic Surgery and Traumatology, General Surgery and Vascular Surgery services collaborated in the study.
Tranexamic acid (TXA) is an antifibrinolytic drug used to reduce bleeding. The POISE3 study has evaluated the efficacy and safety compared to placebo of TXA given at the beginning and end of surgery, in patients at risk of cardiovascular complications undergoing non-cardiac surgery. The study has had a total of 9,535 patients, more than 700 in Spain and 200 in the Hospital de la Santa Creu i Sant Pau, which has been the Spanish hospital with most patients in the study, followed by the Clinical Hospital University Hospital of Valladolid and the Vall d’Hebron University Hospital.
The results show that TXA significantly decreases the primary composite endpoint of bleeding compared to placebo. They also demonstrate its safety, since it does not increase the risk of deep vein thrombosis, heart attack, non-haemorrhagic stroke, or other major vascular complications in the 30 days after surgery.
Most patients undergoing non-cardiac surgery do not receive TXA, but this study could change it. Every year up to 300 million surgeries are performed worldwide and surgical bleeding accounts for more than 40% of transfusions. There is a huge demand for blood products, which is up to 30 million units worldwide. The POISE-3 results may be relevant to healthcare systems around the world, since they identified that the use of TXA could annually prevent more than 8 million bleeding events resulting in transfusion.
Based on the results of the study, Dr. Maria José Martínez, coordinator of the POISE-3 study in Spain and IIB Sant Pau researcher explains that “incorporating the administration of TXA into routine clinical practice of non-cardiac surgery could benefit the health of patients while contributing to a global health problem such as the availability of blood products and their consequent economic cost”.
Reference article
Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martínez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Côté EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 Apr 2. doi: 10.1056/NEJMoa2201171. https://www.nejm.org/doi/10.1056/NEJMoa2201171
