The POISE-3 Trial: Tranexamic Acid in Patients Undergoing Noncardiac Surgery .
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Tranexamic Acid in Patients Undergoing Noncardiac Surgery
N Engl J Med. 2022 Apr 2.9535 patients undergoing non-cardiac surgery were randomized to receive tranexamic acid (n=4757) or placebo (n=4778) at the start and end of surgery. The primary efficacy outcome was a composite bleeding outcome of life-threatening bleeding, major bleeding, or bleeding into a critical organ. The primary safety outcome was a composite endpoint of myocardial injury, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism, which was tested for non-inferiority vs. placebo. The results of the trial found a significantly lower rate of composite bleeding events in the tranexamic acid group vs. placebo (9.1% vs. 11.7%, p<0.001). However, the non-inferiority of tranexamic acid was not established for the composite cardiovascular safety outcome (14.2% vs. 13.9%, p=0.04 [p<0.025 required for non-inferiority]).
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