But, though difference is small, tranexamic acid not noninferior to placebo for primary safety outcome of composite cardiovascular outcome
THURSDAY, April 7, 2022 (HealthDay News) — For patients undergoing noncardiac surgery, the incidence of a composite bleeding outcome is significantly lower with tranexamic acid, while tranexamic acid is not noninferior for the composite cardiovascular outcome, according to a study published online April 2 in the New England Journal of Medicine to coincide with the annual meeting of the American College of Cardiology, held from April 2 to 4 in Washington, D.C.
P.J. Devereaux, M.D., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues conducted a trial involving 9,535 patients undergoing noncardiac surgery who were randomly assigned to receive either tranexamic acid or placebo (4,757 and 4,778 patients, respectively).
The researchers found that a composite bleeding outcome (life-threatening bleeding, major bleeding, or bleeding into a critical organ) at 30 days occurred in 9.1 and 11.7 percent of patients in the tranexamic acid and placebo groups, respectively (hazard ratio, 0.76; 95 percent confidence interval, 0.67 to 0.87; two-sided P < 0.001 for superiority). The composite cardiovascular outcome (myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism) at 30 days occurred in 14.2 and 13.9 percent of the tranexamic acid- and placebo-treated patients, respectively (hazard ratio, 1.02; 95 percent confidence interval, 0.92 to 1.14; one-sided P = 0.04 for noninferiority, which did not meet the prespecified one-sided P value of < 0.025 for noninferiority).
“Although the difference in composite cardiovascular complications between the tranexamic acid group and the placebo group was small, the noninferiority of tranexamic acid was not established,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
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