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Grand Rounds

RCT Results: Does Tranexamic Acid Reduce Severe Bleeding in Noncardiac Surgeries?

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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

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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?

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