TXA POISEd for use in urologic surgery

The POISE-3 trial supports the use of tranexamic acid (TXA) in patients undergoing urologic surgery at increased risk of bleeding.

“TXA reduced the absolute risk of major bleeding by 3.4 percent, corresponding to a 37-percent relative reduction (6.1 percent vs 9.5 percent; hazard ratio [HR], 0.63; p=0.03),” said Dr Kari Tikkinen from the University of Helsinki, Finland, at EAU26.

Major bleeding results in postoperative haemoglobin ≤70 g/L, transfusion of ≥1 unit of RBC, or one of the following interventions: embolization, superficial vascular repair, or nasal packing, Tikkinen explained. “The reduction in major bleeding largely reflected fewer transfusions.”

All TXA recipients who had major bleeding (n=34) received transfusions, and one underwent embolization. In placebo recipients with major bleeding (n=54), the corresponding rates were 52 and three, respectively. Ten in each arm had haemoglobin ≤70 g/L postop.

Of note, when looking at the 30-day primary efficacy outcome (composite of life-threatening, major, and critical organ bleeding), the difference did not reach statistical significance (8.1 percent vs 10.9 percent; HR, 0.73; p=0.11). [EAU 2026, abstract GC26-001]

There were similar rates of thrombosis between the TXA and placebo groups (12.1 percent vs 10.9 percent; HR, 1.12; p=0.52). According to Tikkinen, this was largely driven by myocardial injury after noncardiac surgery (11.2 percent vs 10.2 percent; HR, 1.11; p=0.57), as there were low rates of non-haemorrhagic stroke (0.4 percent for both; HR, 1.01; p=0.99) and symptomatic venous thromboembolism (0.5 percent for both; HR, 1.03; p=0.97).

TXA nearly halved the incidence of ISTH* major bleeding compared with placebo (5.2 percent vs 9.9 percent; HR, 0.52; p<0.01). There were also numerical reductions in the other selected secondary/tertiary outcomes of BIMS** (7.6 percent vs 10.6 percent; HR, 0.70; p=0.08) and transfusions (at least 1 unit: 8.6 percent vs 11.3 percent; HR, 0.75; p=0.14; ≥2 units: 6.7 percent vs 7.6 percent; HR, 0.88; p=0.55), but these fell short of statistical significance.

Of the five deaths reported, three occurred in the TXA arm. No seizures were reported in either arm.

There were no interactions for either the primary efficacy or safety outcome by surgical approach (transurethral vs other), preoperative antithrombotic use within 24 hrs, or cancer status in the subgroup analyses.

Limited evidence in urology

“Bleeding matters in urologic surgery, as it can lead to major complications, transfusions, re-intervention, and longer hospital stay,” Tikkinen said. “TXA is well established in orthopaedic surgery for reducing perioperative bleeding, but evidence in urology is limited and conflicting, uptake is low, and urologic guidelines provide no recommendations.”

The team evaluated 1,124 adults (mean age 70 years, 78 percent men) undergoing inpatient surgery at increased risk of bleeding and cardiovascular events. They were randomized to either TXA 1 g administered intravenously at the beginning and end of surgery (n=556) or placebo (n=568). Nearly 60 percent of participants had active cancer, and a quarter used anti-thrombotic agents within 24 hours preop.

The most common surgical approach was laparoscopic/robotic (44 percent), followed by open (32 percent), transurethral (22 percent), and percutaneous (3 percent). The most common surgical procedure was robotic radical prostatectomy (14 percent) and transurethral resection of the prostate/transurethral benign prostatic obstruction surgery (12 percent). Approximately a third underwent other procedures.

According to Tikkinen and colleagues, this is the largest trial of TXA in urology, underscoring its reduction in postop bleeding. “The importance of this reduction depends on individual preferences and baseline risks.”

“TXA is inexpensive and easy to administer. Wider use would reduce bleeding and transfusions, and it would be particularly relevant in locations with limited resources,” Tikkinen said. “Our results will inform global practice and support evidence-based decision-making for urologic patients.”