Clinical question: Does tranexamic acid reduce the incidence of life-threatening perioperative bleeding in patients undergoing noncardiac surgery without increasing the risk of major cardiovascular adverse events?
Background: Large surgical trials have shown that tranexamic acid reduces the incidence and severity of perioperative bleeding in patients undergoing a cesarean section or cardiac surgery. Other, smaller trials have suggested similar findings with tranexamic acid in patients undergoing orthopedic surgery as well. But, there are limited data on the use of tranexamic acid in patients undergoing non-orthopedic, noncardiac surgeries. And, there are no large trials to show whether the use of tranexamic acid would increase the risk of thrombotic events or major cardiovascular complications after noncardiac surgery.
Study design: Randomized controlled trial
Setting: 114 hospitals in 22 countries between June 2018 and July 2021
Synopsis: 9,535 patients with a mean age of 69.4 years (43.9% women). Patients were primarily from Europe (39.8%), North America (31.1%), and the Asia-Pacific region (27.0%). Before and after surgery, 4,757 patients were randomly assigned to receive tranexamic acid (1 gram per dose) and 4,778 patients were randomly assigned to receive a placebo. Most patients underwent non-orthopedic, noncardiac surgery (77%). At 30 days, patients who received tranexamic acid before and after noncardiac surgery had significantly less life-threatening bleeding, major bleeding, or critical-organ bleeding compared with those who received placebo (9.1% versus 11.7%; HR, 0.76; 95% CI, 0.67-0.87; absolute difference, -2.6%; 95% CI, -3.8 to -1.4%; P <.0001 for superiority). The primary safety outcome (composite of vascular events including myocardial injury, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days) occurred in 14.2% of patients assigned to receive tranexamic acid compared with 13.9% of those assigned to receive the placebo (HR, 1.02; 95% CI, 0.92-1.14; absolute difference, 0.3%; 95% CI, -1.1 to 1.7%; P = 0.04 for noninferiority).
Bottom Line: Tranexamic acid demonstrated a reduced incidence of perioperative bleeding in patients undergoing noncardiac surgeries, however professional society guidelines and more familiarity with the tranexamic acid are likely needed before its use in regular clinical practice.
Citation: Devereaux PJ, et al. tranexamic acid in patients undergoing noncardiac surgery. N Engl J Med. 2022; 386:1986-1997. doi: 10.1056/NEJMoa2201171.
Dr. Menon is the interim co-medical director, section of hospital medicine at Atrium Health Wake Forest Baptist and an assistant professor of internal medicine, Wake Forest School of Medicine, Winston-Salem, N.C.