Tranexamic acid significantly reduced the relative risk of major perioperative bleeding by 26%, with an absolute reduction of 2.5%, in general surgery patients without increasing cardiovascular risks, according to a recent study.
The safety and efficacy of tranexamic acid (TXA) in reducing perioperative bleeding in patients undergoing general surgery were evaluated in a substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial. This international, multicenter, double-blind, randomized clinical trial, published in JAMA Surgery, included 3,260 general surgery patients from a larger cohort of 9,535 noncardiac surgery patients aged 45 years or older, all at elevated cardiovascular risk and requiring at least an overnight hospital stay post-surgery.
Patients were randomized 1:1 to receive either a 1-g intravenous bolus of TXA or placebo at the start and end of surgery. The primary efficacy outcome—a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ—occurred in 8.0% of patients receiving TXA compared with 10.5% in the placebo group (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.59-0.93; P = .01), demonstrating statistical significance. In absolute terms, 130 patients in the TXA group experienced major bleeding compared to 171 in the placebo group. The primary safety outcome—a composite of myocardial injury, stroke, peripheral arterial thrombosis, or venous thromboembolism—was observed in 11.9% of TXA recipients and 12.5% of placebo recipients (HR, 0.95; 95% CI, 0.78-1.16; P = .63), indicating no significant difference.
Subgroup analyses revealed significant reductions in bleeding risk among patients undergoing hepatopancreaticobiliary surgery (15.0% vs. 25.0%; HR, 0.55; 95% CI, 0.34-0.91) and colorectal surgery (9.3% vs. 13.6%; HR, 0.67; 95% CI, 0.45-0.98). These findings highlight TXA’s effectiveness in high-risk general surgery subcategories. Additionally, TXA was associated with a reduced need for transfusion of at least one unit of packed red blood cells (8.6% vs. 10.8%; odds ratio [OR], 0.77; 95% CI, 0.61-0.97; P = .03) without increasing thromboembolic events.
Theoretical concerns about thromboembolic risks with TXA were not borne out in this study. Myocardial injury rates were comparable between groups (11.9% vs. 12.5%; HR, 0.95; P = .63), and no significant differences were observed in other thromboembolic events.
The study’s primary limitation is that subgroup analyses were not specifically powered for the categories examined. Variations in bleeding risk across surgical subcategories and differences in hemostatic management practices may have influenced the findings. Nevertheless, this trial remains the largest evaluation of TXA’s safety and efficacy in general surgery to date.
An updated meta-analysis involving 191 randomized controlled trials (RCTs) with 40,621 patients further supports the safety of TXA, showing that the noninferiority margin for thromboembolic events was met (RR, 1.02; 95% CI, 0.94-1.11). The trial’s registration can be found at ClinicalTrials.gov (Identifier: NCT03505723).
Full disclosures can be found in the study.
