Tranexamic Acid in Patients Undergoing Noncardiac Surgery
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2022;10(7):5 N Engl J Med. 2022 Apr 2.What this means for my practice?
The results of this study found that tranexamic acid administered before and after non-cardiac surgery had a lower likelihood of life-threatening bleeding, major bleeding or bleeding in a critical organ. However, tranexamic acid was not observed to be non-inferior to placebo for the likelihood of the composite cardiovascular events. This study was limited by the early stoppage of the trial due to slowed recruitment, however, more than 95% of the planned sample size was recruited.
Study Summary
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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