A single dose of tranexamic acid (TXA) at the beginning and end of surgery significantly reduced major bleeding in patients undergoing noncardiac surgery compared with placebo, based on findings from the POISE-3 trial presented April 2 at ACC.22 and simultaneously published in the New England Journal of Medicine.
The study randomized 9,535 patients undergoing noncardiac surgery at 114 centers in 22 countries to receive TXA (1-g intravenous bolus) or placebo at the start and end of surgery. The primary efficacy outcome was a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days. The primary safety outcome was a composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days. Patients' average age was 70 and 56% were men.
Overall results showed a composite bleeding outcome event occurred in 9.1% of those patients in the TXA group (n= 433/4,757) compared with 11.7% of patients in the placebo group (n=561/4,778 patients). Rates of adverse cardiovascular events were similar in both groups (14.2% for patients who received TXA, 13.9% for those who received a placebo). Researchers noted the benefit of TXA treatment was consistent, regardless of the type of noncardiac surgery patients received and whether patients' hemoglobin was normal or low before surgery.
"We saw an unequivocal benefit of treatment [with TXA] on preventing bleeding and blood transfusions, with no increased risk of complications," said P.J. Devereaux, MD, the study's lead author. "Given the number of people worldwide who undergo noncardiac surgery every year and the frequency of postsurgical bleeding complications, this has the potential to help a lot of patients, and I hope it will lead to a substantial change in practice."
A limitation of the study is that it did not meet its predetermined margin for determining that TXA was no less safe than the placebo. However, statistical analysis showed with a probability of more than 95% that the safety of TXA and placebo were similar. A beneficial reduction in bleeding risk must be weighed against a low probability of a small increase in the risk of a heart attack, stroke or another cardiovascular adverse event, Devereaux said.
3 April 2022
De. Nabil Paktin
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