ATACAS: Outcomes mixed for tranexamic acid vs. placebo in patients undergoing coronary artery surgery
Tranexamic acid during coronary artery surgery was not associated with increased risk for death or thrombotic complications, but was linked to lower risk for bleeding complications and higher risk for postoperative seizures, according to data from the ATACAS trial published in The New England Journal of Medicine.
“Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes,” Paul S. Myles, MPH, MD, a professor of anesthesia and perioperative medicine at Monash University and director of anesthesia and perioperative medicine at the Alfred Hospital in Melbourne, Australia, and colleagues wrote. “Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects.”
In the study, high-risk patients scheduled to undergo coronary artery surgery were randomly assigned tranexamic acid (n = 2,311) or placebo (n = 2,320). The primary outcome was a composite of death and thrombotic complications, defined as nonfatal MI, stroke, pulmonary embolism, renal failure or bowel infarction, at 30 days.
The trial was a two-by-two factorial design in which patients also were assigned aspirin or placebo. Study results published in February showed that aspirin had no effect on outcomes in this population.
Within 30 days of surgery, 16.7% of the tranexamic acid group had a primary outcome compared with 18.1% of the placebo group (RR = 0.92; 95% CI, 0.81-1.05). Patients in the tranexamic acid group used fewer total number of units of bloods for transfusion than the placebo group (4,331 units vs. 7,994 units; P < .001).
Additionally, major hemorrhage or cardiac tamponade leading to reoperation occurred in 1.4% of the tranexamic acid group and 2.8% in the placebo group (P = .001). Seizures occurred in 0.7% of the tranexamic acid group and 0.1% of the placebo group (P = .002), according to the researchers.
“In summary, we found no evidence that tranexamic acid increases the risk of death and thrombotic complications after coronary artery surgery,” researchers wrote. “Tranexamic acid was associated with a lower risk of bleeding complications than placebo but also with a higher risk of postoperative seizures.” – by Cassie Homer
Disclosure: The researchers report no relevant financial disclosures.