1. Compared to placebo, tranexamic acid (TXA) use in noncardiac surgery patients reduced the risk of bleeding 30 days postoperatively in non-cardiac surgery patients.
2. TXA use was associated with a slightly elevated risk of cardiovascular complications 30 days post-operatively compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Perioperative bleeding is a common complication of non-cardiac surgery associated with an increased risk of mortality. TXA has been previously demonstrated to decrease bleeding in patients undergoing cesarean sections or cardiac surgery. However, it is unclear whether TXA reduces risk of postoperative bleeding in non-cardiac surgery patients. This randomized control trial compared postoperative bleeding outcomes in non-cardiac patients administered either a placebo control or TXA immediately before and after surgery. Additionally, cardiovascular risk associated with TXA use in this population was assessed. At 30-days postoperatively, bleeding outcomes were significantly lower in the TXA group compared to the placebo control. Notably, TXA was associated with a small but significant increase in risk of adverse cardiovascular outcomes during the follow-up period. A major limitation of this trial is that it was interrupted prematurely due to fiscal deficit. However, over 95% of the originally planned sample size was successfully enrolled.
In-Depth [randomized control trial]: The Perioperative Ischemic Evaluation–3 (POISE-3) randomized control trial compared the postoperative outcomes of non-cardiac patients receiving either one gram of intravenous TXA (n=4,757) or a placebo control (n=4,778) perioperatively. The primary outcome was composite bleeding (life-threatening bleeding, major bleeding, or bleeding into a critical organ) 30 days postoperatively. The composite bleeding outcome occurred in 433 patients (9.1%) in the TXA group and in 561 patients (11.7%) in the placebo group (hazard ratio [HR], 0.76; 95% Confidence Interval [CI], 0.67 to 0.87). Further, bleeding independently associated with death occurred in 416 patients in the TXA group (8.7%) and in 514 patients in the placebo group (11.3%) during the follow-up period (HR, 0.76; 95% CI, 0.67 to 0.87). TXA safety was evaluated using a composite cardiovascular outcome (myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism) within the 30-day follow-up period. This occurred in 649 patients (14.2%) in the TXA group and 639 patients (13.9%) in the placebo group (HR, 1.02; 95% CI, 0.92 to 1.14). Overall, this study demonstrated that in patients undergoing non-cardiac surgery, the incidence of life-threatening bleeding, major bleeding, and bleeding into a critical organ was significantly lower in those receiving TXA compared to placebo. Though, TXA may be associated with a slight increase in postoperative adverse cardiovascular events.
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