Kari Tikkinen, MD, PhD, discusses POISE-3 findings on tranexamic acid in urologic surgery

In this video, Kari A.O. Tikkinen, MD, PhD, discusses findings from the POISE-3 trial evaluating perioperative tranexamic acid (TXA) in patients undergoing urologic surgery, including its impact on bleeding and thrombotic events.¹ Tikkinen is a professor of urology at the University of Helsinki in Finland.

Tikkinen explains that evidence supporting TXA use in urologic surgery has historically been limited and conflicting, with previous studies often being small or unblinded. Concerns about clot retention and thrombotic complications, along with the lack of recommendations from major urologic guidelines, have contributed to relatively limited use of the inexpensive antifibrinolytic agent in urology. POISE-3 was designed to provide more robust evidence through an international, placebo-controlled trial that included patients undergoing a broad range of urologic procedures.

The primary efficacy outcome was a 30-day bleeding composite (life-threatening/major/critical organ). The primary safety outcome was 30-day thrombosis composite, which included myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (VTE).

Among 1124 urologic participants, 556 received TXA and 568 received placebo. The composite bleeding outcome occurred in 8.1% of patients in the TXA arm and in 10.9% of patients in the placebo arm (HR, 0.73; 95% CI, 0.50 to 1.07). Major bleeding occurred in 6.1% of patients receiving TXA compared with 9.5% receiving placebo (HR, 0.63; 95% CI, 0.41 to 0.97). Tikkinen noted that the absolute benefit will vary according to a patient's baseline bleeding risk, making TXA particularly relevant for patients at higher risk of bleeding.

The primary safety outcome occurred in 12.1% of patients receiving TXA and 10.9% receiving placebo (HR, 1.12; 95% CI, 0.79 to 1.58), while patient-important thrombotic events were infrequent, with 2 strokes in each group and 3 VTEs in each group. Although the limited number of stroke and VTE events makes those estimates imprecise, Tikkinen emphasizes that the study included patients with baseline cardiovascular and bleeding risk factors.

“Compared [with] many other earlier trials, we had patients who were at a higher risk of thrombosis. There [were] inclusion criteria so that we would [have] higher bleeding and higher thrombosis risk patients. We did not exclude those higher-risk patients. So that's why this is very clinically relevant,” he explained.

Overall, based on the results, Tikkinen concluded, “So, it looks like it works, and it looks like it's safe, and [it’s] very cheap. It's definitely something we believe that urologists should use more.”

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