Tranexamic Acid Reduces Major Bleeding in Urologic Surgery

Use of tranexamic acid (TXA) reduced the risk of major bleeding in patients undergoing urologic surgery, results from the randomized POISE-3 trial showed.

Among more than 1,100 patients, 6.1% of those in the TXA group experienced major bleeding compared with 9.5% in the placebo group (HR 0.63, 95% CI 0.41-0.97, P=0.03), reported Kari Tikkinen, MD, PhD, of the University of Helsinki and Helsinki University Hospital, at the European Association of Urology annual congress in London.

There were no statistically significant differences in the 30-day efficacy outcome (a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ) or the 30-day safety outcome (a composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism).

“I would advocate for more use of TXA,” Tikkinen said. “It is inexpensive. It is easy to administer, especially in those areas of the world where you have … difficulty getting blood products and you have limited resources.”

The significant reduction in major bleeding in the TXA group “means less transfusions,” he noted. “This major bleeding outcome is mostly driven by transfusions.”

While fewer transfusions of at least 1 unit were administered in the TXA group (8.6% vs 11.3% with placebo), the difference was not significant (P=0.14).

“Perioperative bleeding is a major concern across urologic surgery,” noted study discussant Sarah P. Psutka, MD, MS, of the University of Washington and Fred Hutchinson Cancer Center in Seattle.

While efforts are being made to reduce the risk of blood loss, transfusion rates “remain relatively stagnant, especially in some of our open oncologic procedures,” she said. “With the emergence of robotic procedures … we improve upon that, but these are major risks across the board of our scope of practice, and clearly there are significant implications of blood loss and transfusions.”

TXA is “easily accessible, cost effective, and actually utilized in many of our hospitals already among our general surgery, orthopedic, and trauma colleagues,” she added. “This analysis provides significant evidence for us to consider the addition of this agent to our perioperative ERAS [Enhanced Recovery After Surgery] pathways for urological surgical patients at high risk of bleeding.”

While TXA is established in several surgical areas, Tikkinen said that the evidence for it is “uncertain,” as randomized trials have produced conflicting results.

For example, TXA failed to reduce the need for red blood cell transfusion following surgery for liver cancer, including colorectal liver metastases, in one placebo-controlled trial, while a cluster randomized trial showed that increasing the use of perioperative TXA reduced blood transfusions during major noncardiac surgeries with no apparent impact on clotting events.

As for urologic surgery trials, the TRANEX-URO study demonstrated that the use of TXA in open radical prostatectomy resulted in lower transfusion rates, while the more recent TACT trial showed no reduction in blood loss or transfusions in radical cystectomy.

POISE-3 was an international, blinded trial of nearly 10,000 patients ages 45 and up with increased bleeding and cardiovascular risk who were undergoing surgery and expected to require overnight admission. The primary analysis of the POISE-3 trial showed reduced bleeding across a variety of noncardiac surgeries.

Of the 1,124 urologic surgery patients in this analysis, mean age was 69.7, 78.3% were men, 58.5% had active cancer, 91% had a history of hypertension, and 25.2% used antithrombotics within 24 hours preoperatively.

Patients underwent robotic radical prostatectomy (n=156), transurethral resection of the prostate (n=138), laparoscopic radical nephrectomy (n=86), and open radical cystectomy (n=76), among other surgeries. The surgical approach was laparoscopic/robotic in 489 patients, open in 360, transurethral in 244, and percutaneous in 31.

The use of TXA appeared to be safe, with no clear signal of increased risks of stroke or venous thromboembolism (VTE), although the study was underpowered for thrombosis estimates. In each group, there were two non-hemorrhagic strokes and three cases of symptomatic VTE.