Tranexamic Acid Reduces Severe Bleeding Risk in Patients Undergoing Noncardiac Surgery

The American College of Cardiology (ACC) & The New England Journal of Medicine (NEJM):

Key Prescribing Notes:

Perioperative bleeding is common complications in patients undergoing noncardiac surgery, is associated with increased morbidity and mortality.

The goal of the POISE-3 trial was to determine whether tranexamic acid, when used in patients undergoing noncardiac surgery who are at risk of bleeding and vascular events, could reduce the occurrence of life-threatening, major, and critical organ bleeding, as well as whether it would impact the occurrence of major vascular complications within 30 days.

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 The American College of Cardiology 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.

Overall results showed a composite bleeding outcome event occurred in 9.1% of those patients in the TXA group compared with 11.7% of patients in the placebo group. 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).

Among patients undergoing noncardiac surgery, tranexamic acid significantly reduced the risk of the composite of life-threatening, major, and critical organ bleeding.

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Abstract

Background

Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding.

Methods

We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125.

Results

A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group. A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group.

Conclusions

Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established.

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