Large randomized clinical trials have shown that tranexamic acid safely reduces bleeding in patients undergoing cardiac surgery or cesarean sections, and evidence from orthopedic surgeries suggest that tranexamic acid is also safe and effective. Limited data, however, exist for patients undergoing nonorthopedic or noncardiac surgeries. The Perioperative Ischemic Evaluation-3 (POISE-3) trial was an international, randomized controlled trial of 9535 inpatients (mean age, 69.4 years; 43.9% female) undergoing noncardiac surgery who were at risk for bleeding. A total of 4757 patients were randomized to receive tranexamic acid and 4778 to receive placebo at the start and end of surgery. Patients in the tranexamic acid group had a lower incidence of bleeding (i.e, life-threatening, major, or bleeding into a critical organ) than patients in the placebo group (9.1% vs 11.7%, respectively; two-sided P<0.001 for superiority). However, questions remain about the cardiovascular risk of using tranexamic acid in these patients, and noninferiority was not established. At 30 days after randomization, 14.2% of patients (649/4581) in the tranexamic acid group had a cardiovascular event (i.e,. myocardial infarction, nonhemorrhagic stroke, or thrombosis) compared to 13.9% (639/4601) in the placebo group (one-sided P = 0.04 for noninferiority). A dose of tranexamic acid at the start and end of noncardiac surgeries may reduce bleeding, but concerns remain about the safety.
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