Tranexamic Acid is an antifibrinolytic which has been shown to reduce bleeding in orthopedic patients and cardiac surgery. But evidence for its use in non-cardiac surgery is still limited.
The aim of this study was to assess whether tranexamic acid reduces the incidence of bleeding events, which include life threatening bleeding, major bleeding, or bleeding into a critical organ (superiority design) and MACE incidence assessment (non-inferiority design) at 30 days, compared against placebo.
The study randomized 9535 patients, mean age 69, considered at risk of bleeding and cardiovascular events, 76.8% with non-orthopedic surgery. The dose of tranexamic acid was 1gr. both at the start and end of surgery.
The use of tranexamic acid significantly reduced bleeding incidence (HR 0.76, CI95% 0.67-0.87, p≤.001), with no evidence of MACE reduction (HR 1.02, CI95% 092-1.14, p: 0.04) and without reaching non-inferiority.
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Within the adverse events there was higher risk of seizures (HR 3.35), with no significant differences in serious events (5.5% vs 5.1% p:0.16).
Conclusions
In patients at risk of bleeding and cardiovascular events set to receive non-cardiac surgery, the use of tranexamic acid significantly reduces bleeding compared against placebo. Despite the low rate of MACE in both groups, non-inferiority was not reached for cardiovascular events.
Dr. Omar Tupayachi.
Member of the editorial board, SOLACI.org
Original Title: Poise-3: Tranexamic Acid in Patients Undergoing Noncardiac Surgery
Reference: Devereaux, P. J., Marcucci, M., Painter, T. W., Conen, D., Lomivorotov, V., Sessler, D. I., Chan, M. T. V., Borges, F. K., Martínez-Zapata, M. J., Wang, C.-Y., Xavier, D., Ofori, S. N., Wang, M. K., Efremov, S., Landoni, G., Kleinlugtenbelt, Y. V., Szczeklik, W., Schmartz, D., Garg, A. X., … POISE-3 Investigators. (2022). Tranexamic acid in patients undergoing noncardiac surgery. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2201171
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