Safety and Efficacy of Tranexamic Acid in Urologic Surgery: Results from the International, Randomized, Placebo-Controlled POISE-3 Trial

BACKGROUND AND OBJECTIVE: Perioperative bleeding is common. Evidence for tranexamic acid (TXA) in urology remains limited and conflicting, and major urologic guidelines provide no recommendations. In an a priori planned analysis, we evaluated TXA among patients undergoing urologic surgery in POISE-3. METHODS: POISE-3 was an international randomized trial of patients undergoing surgery with bleeding and cardiovascular risk factors. Participants received TXA (1 g intravenous bolus at surgery start and end) or placebo. The primary efficacy outcome was a 30-day bleeding composite (life-threatening/major/critical organ), and the primary safety outcome was a 30-day thrombosis composite (myocardial injury after noncardiac surgery [MINS], nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism [VTE]). KEY FINDINGS AND LIMITATIONS: Among 1124 urologic participants (556 TXA and 568 placebo), 489 had laparoscopic/robotic, 360 open, 244 transurethral, and 31 percutaneous surgery. The composite bleeding outcome occurred in 45 (8.1%) with TXA and in 62 (10.9%) with placebo (hazard ratio [HR] = 0.73, 95% confidence interval [CI] = 0.50-1.07). Major bleeding occurred in 34 (6.1%) with TXA and in 54 (9.5%) with placebo (HR = 0.63, 95% CI = 0.41-0.97). The composite safety outcome occurred in 67 (12.1%) with TXA and in 62 (10.9%) with placebo (HR = 1.12, 95% CI = 0.79-1.58; MINS: 62 vs 58; strokes: 2 vs 2; VTEs: 3 vs 3). We identified no interactions by surgical approach, cancer status, or recent antithrombotic usage. Patient-important thrombotic events were few, limiting precision for stroke and VTE estimates. CONCLUSIONS AND CLINICAL IMPLICATIONS: TXA reduced major bleeding and supports perioperative use in urologic surgery, especially when the bleeding risk is high.