At risk for bleeding and cardiovascular complications (e.g., known atherosclerotic disease)
TXA: 1 g intravenous bolus at start and end of surgery
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
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
TXA group: 4757 patients | Placebo: 4778 patients
There was a significantly lower incidence of the composite bleeding outcome in the TXA group
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
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
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
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