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Research showed prophylactic tranexamic acid lowers perioperative bleeding risk without increasing cardiovascular risk across many types of general surgery.
A substudy analysis of the Perioperative Ischemic Evaluation-3 (POISE-3) trial showed that prophylactic tranexamic acid (TXA) significantly lowered the risk of perioperative bleeding without increasing cardiovascular risk for patients undergoing general surgery procedures, according to findings published in JAMA Surgery.
POISE-3 was a blinded, international, multicenter, randomized clinical trial that enrolled 9,535 patients aged 45 and older undergoing noncardiac surgery. Participants had increased cardiovascular risk and were expected to require at least an overnight hospital stay after surgery.
For the substudy, Maura Marcucci, MD, MSc, and colleagues evaluated the safety and efficacy of treatment with prophylactic TXA (1 g bolus IV) compared with placebo at the start and end of surgery.
A total of 3,260 patients underwent a general surgery procedure. The patients’ mean age was 68.6 years, 53.4% were men, and 46.6% were women. The primary efficacy endpoint was a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ. The primary safety endpoint was a composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days.
Reduction in Major Bleeding Across All Surgery Types
The researchers found that prophylactic TXA significantly reduced major bleeding events compared with placebo (8.0% vs 10.5%, respectively; HR, 0.74; 95% CI, 0.59-0.93; P =0.01). Additionally, 11.9% and 12.5% of patients in the TXA and placebo arms, respectively, met the primary safety outcome (HR, 0.95; 95% CI, 0.78-1.16; P=0 .63).
The findings also showed no significant interaction by type of surgery (general surgery vs nongeneral surgery) on the primary efficacy (P=0.81) and safety (P=0.37) outcomes. Across subtypes of general surgery, TXA decreased the composite bleeding outcome in 332 patients undergoing hepatopancreaticobiliary surgery (HR, 0.55; 95% CI, 0.34-0.91) and 940 patients undergoing colorectal surgery (HR, 0.67; 95% CI, 0.45-0.98). Furthermore, the researchers observed no significant interaction across subtypes of general surgery (P=0.68).
