Tranexamic acid significantly lowers composite bleeding in patients undergoing noncardiac surgery: POISE trial

Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo, according to the latest research published in NEJM.

Perioperative bleeding, a common complication in noncardiac surgery patients, is linked to an increased risk of morbidity and mortality.

Tranexamic acid has been shown in large surgical trials to minimize the frequency and severity of bleeding in patients following cesarean section or cardiac surgery.

Tranexamic acid may lower the incidence and severity of bleeding in patients undergoing orthopedic surgery, according to encouraging evidence from small trials; however, there is inadequate data on its usage in patients undergoing non-orthopedic non-cardiac procedures.

Tranexamic acid is an antifibrinolytic drug, and trials have not been large enough to establish whether tranexamic acid increases the risk of thrombotic events in noncardiac surgery.

The researchers P.J. Devereaux et. al conducted a Perioperative Ischemic Evaluation–3 (POISE-3) trial to find out if tranexamic acid results in a lower incidence of life-threatening bleeding, major bleeding, or bleeding into a critical organ than placebo and is it non-inferior to placebo with respect to the incidence of major cardiovascular complications within 30 days in patients undergoing noncardiac surgery who are at risk for bleeding and cardiovascular events.

A total of 9535 patients underwent randomization.

The researchers found that:

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.

Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established.

"Noninferiority was not established for the primary safety outcome. Health care providers and patients will have to weigh a clear beneficial reduction in the incidence of composite bleeding outcome events against the low probability of a small increase in the incidence of composite cardiovascular outcome events," the researchers concluded.

Reference:

P.J. Devereaux, M.D., Ph.D., Maura Marcucci, M.D., Thomas W. Painter, M.B., Ch.B., et. al, Tranexamic Acid in Patients Undergoing Noncardiac Surgery, N Engl J Med 2022; 386:1986-1997, DOI: 10.1056/NEJMoa2201171