Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, 386(21), 1986–1997. https://doi.org/10.1056/NEJMoa2201171 Dr. P. J. Devereaux et al
Points
- TXA is used in patients undergoing cardiovascular surgery to prevent excessive blood loss; however, its effects on postoperative non-cardiac surgery patients are still unclear
- The POISE-3 RCT explored TXA’s effects in terms of composite bleeding across non-cardiac surgery patients by assessing its effects on both a group treated with TXA and a placebo control
- After 30 days of postoperative monitoring, composite bleeding occurred significantly less in patients treated with TXA compared to those in the placebo control; TXA was also found to be associated with a slight increase in postoperative adverse cardiovascular events
Summary
Tranexamic acid (TXA) has long been used to prevent excessive blood loss in patients undergoing cardiac surgery. However, its effects on non-cardiac surgery patients post-operation are still unclear. This particular randomized control trial (RCT), called the Perioperative Ischemic Evaluation-3 (POISE-3) RCT, compared post-operative bleeding across patients who underwent non-cardiac surgery; to be specific, the study administered both TXA and a placebo control to patients immediately before and after surgery. Additionally, the cardiovascular risk of TXA was also examined.
POISE-3 compared postoperative outcomes of patients given either one (1) gram of TXA (n=4,757) or a placebo control (n=4,778), both given perioperatively. The primary outcome of the study was composite bleeding, hereby defined as bleeding that is either major, proceeding into a critical organ, or otherwise life-threatening, some thirty (30) days after surgery. 433 patients in the TXA group (9.1%) experienced composite bleeding, while the same happened for 561 patients in the placebo group (11.7%) (hazard ratio [HR], 0.76; 95% Confidence Interval [CI], 0.67 to 0.87). Bleeding independently associated with death during the follow-up period, meanwhile, occurred in 416 patients for the TXA group (8.7%) and in 514 patients in the placebo group (11.3%) (HR, 0.76; 95% CI, 0.67 to 0.87). In the 30 days that followed, the researchers evaluated the safety of TXA via a composite cardiovascular outcome (myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism). This outcome occurred in 649 patients in the TXA group (14.2%) and 639 patients in the placebo group (13.9%) (HR, 1.02; 95% CI, 0.92 to 1.14).
In summary, the researchers showed that when undergoing non-cardiac surgery, patients experienced a significantly lower incidence of composite bleeding when receiving TXA compared to placebo control. However, TXA may also be associated with a slight increase in postoperative adverse cardiovascular events. However, the study was prematurely ended due to a fiscal deficit; despite this, more than 95% of the original sample size was successfully enrolled in the study.
Link to the original article: https://www.nejm.org/doi/full/10.1056/NEJMoa2201171
References 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., … Leslie, K. (2022). Tranexamic acid in patients undergoing noncardiac surgery. New England Journal of Medicine, 386(21), 1986–1997. https://doi.org/10.1056/NEJMoa2201171
