No increased risk of death or thrombotic complications with tranexamic acid
medwireNews: Tranexamic acid reduces the risk of bleeding in patients undergoing coronary artery surgery without increasing the risk of death or thrombotic complications, results of the placebo-controlled ATACAS trial suggest.
As reported in The New England Journal of Medicine, the primary outcome – a composite of death and thrombotic complications during the first 30 days after surgery – occurred in 16.7% of 2311 patients in the tranexamic acid group, versus 18.1% of 2320 patients in the placebo group (relative risk [RR]=0.92).
“[W]e found no evidence that the use of tranexamic acid resulted in a higher risk of death or thrombotic complications than that with placebo among patients undergoing coronary-artery surgery,” write Paul Myles (Alfred Hospital, Melbourne, Victoria, Australia) and colleagues.
Thrombotic events included nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction.
The patients, who were at risk of major complications due to age or coexisting conditions, were randomly assigned to receive placebo or tranexamic acid prior to undergoing elective coronary artery bypass grafting (CABG).
The authors observed lower rates of bleeding-related outcomes among patients receiving tranexamic acid; a total of 4331 units of any blood products were transfused in the tranexamic acid group, compared with 7994 in the placebo group. Fewer patients receiving tranexamic acid experienced major hemorrhage or cardiac tamponade leading to reoperation compared with those receiving placebo (1.4 vs 2.8%).
Myles and colleagues note that in a cardiac surgery practice similar to the centers in which the trial was conducted, adopting the use of tranexamic acid “would save approximately 57 units of blood products for every 100 patients treated.”
Patients receiving tranexamic acid were 7.6 times more likely to experience postoperative seizures than those receiving placebo, with rates of 0.7% and 0.1%, respectively. In a post-hoc analysis, the authors showed that patients who experienced postoperative seizures were approximately 22 times more likely to experience a stroke and 10 times more likely to die compared with those who did not have seizures.
“The number needed to harm to cause 1 additional patient to have one or more seizures with tranexamic acid treatment within 30 days after surgery was 177 patients,” explain the study authors.
They add: “The relationship of postoperative seizures with stroke and death observed in this trial suggests a possible underlying thromboembolic cause of the seizures.”
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