BACKGROUND AND PURPOSE:

• Devereaux et al. (NEJM, 2022) assessed whether TXA lowered the incidence of bleeding and incidence of major cardiovascular complications following noncardiac surgery

METHODS:

• International randomized, controlled trial
  • Perioperative Ischemic Evaluation–3 (POISE-3) trial
• Participants
  • ≥45 years
  • Undergoing noncardiac surgery
  • At risk for bleeding and cardiovascular complications (e.g., known atherosclerotic disease)
• Interventions
  • TXA: 1 g intravenous bolus at start and end of surgery
  • Placebo
• Study design
  • To establish the noninferiority of tranexamic acid vs placebo for primary safety outcome (cardiovascular events at 30 days)
    • Upper boundary of the one-sided 97.5% confidence interval for the hazard ratio (HR) had to be <1.125
    • One-sided P value had to be <0.025
• Primary outcome
  • Composite bleeding outcome at 30 days
    • Life-threatening bleeding | Major bleeding | Bleeding into a critical organ
• Primary safety outcome
  • Composite cardiovascular outcome at 30 days
    • Myocardial injury after noncardiac surgery | Nonhemorrhagic stroke | Peripheral arterial thrombosis | Symptomatic proximal VTE

RESULTS:

• TXA group: 4757 patients | Placebo: 4778 patients
• There was a significantly lower incidence of the composite bleeding outcome in the TXA group
  • TXA: 9.1%
  • Placebo: 11.7%
  • HR 0.76 (95% CI, 0.67 to 0.87)
  • Absolute difference: −2.6 percentage points (95% CI, −3.8 to −1.4)
  • Two-sided P<0.001 for superiority
• Noninferiority of TXA could not be established for composite cardiovascular events
  • TXA: 14.2%
  • Placebo: 13.9%
  • HR 1.02 (95% CI, 0.92 to 1.14)
  • Upper boundary: 1.14
  • Absolute difference 0.3 percentage points (95% CI, −1.1 to 1.7)
  • One-sided P=0.04 for noninferiority

CONCLUSION:

• For patients undergoing noncardiac surgery, TXA significantly reduced severe bleeding vs placebo
• There was a small, non-significant increase in cardiovascular events with TXA and noninferiority to placebo could not be established
• The authors state

Given that 300 million surgeries occur annually worldwide the results of the POISE-3 trial indicate the potential for large public health and clinical benefits if tranexamic acid becomes standard practice in noncardiac surgery

Learn More – Primary Sources:

Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Related ObG Topics:

Single IV Dose of TXA Prior to Surgery: Safety and Efficacy Review

Meta-Analysis of Topical TXA to Reduce Surgical Blood Loss

Results From the Landmark Trial on Tranexamic Acid for Postpartum Hemorrhage

Meta-Analysis: Is There an Association Between TXA and Increased Risk for Thromboembolic Events?