Event photos courtesy ©ACC/Nick Agro 2022
The large, international trial, POISE-3, has found a drug that helps the blood to clot reduced life-threatening, major and critical organ bleeding in patients undergoing non-cardiac surgery – without increasing major vascular complications.
The drug tested, tranexamic acid (TXA), was given to patients at risk of bleeding or vascular complications. The study found that TXA did not increase deep vein clotting known as VTE, heart attack, non-hemorrhagic stroke, or other major vascular complication in the 30 days after surgery.
“Our finding of a safe, effective reduction in surgical bleeding has the potential to help healthcare systems on a broader, trickle-down effect,” says the study’s lead investigator, PHRI Senior Scientist PJ Devereaux.
“Patients having non-cardiac surgery commonly bleed. Surgical bleeding accounts for more than 40% of all transfusions, and more blood products are needed than are available today around the world,” he notes. “Reduced bleeding that’s safe for patients could address this challenge.”
The findings were published today in The New England Journal of Medicine, simultaneous with Devereaux’s presentation at ACC 2022‘s first Late-Breaking Clinical Trials session.
PHRI Scientist and coauthor Maura Marcucci notes that “in our trial, TXA demonstrated a consistent reduction in the risk of bleeding based on several definitions, and it reduced the risk of receiving one or two, to four transfusions.”
In the study, half of 9535 patients in 24 countries were randomly assigned TXA, half placebo. Patients were 45 years or older (average age of 69); 44% of them were female.
“Given that 300 million surgeries occur annually around the world, tranexamic acid has the potential for large public health and clinical benefits, adds Marcucci, who presents separate findings from POISE-3 on April 4 at ACC 2022 at the session, The effects of a hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery.