*For medical professionals only
“img class=”responsive ” sizes=”(min-width: 320px) 320px, 100vw” src=”https://mmbiz.qpic.cn/mmbiz_png/x5F5KAyDKw19I4VvcibrfNia7lD1fial5KribXqZxjxMxtoc3ichKKz6ib3w5kJias8QNRBYGn80MM0AxEgOvRLib>p>width=”6400″ >Perioperative bleeding is a common complication in patients undergoing noncardiac surgery and is associated with increased morbidity and mortality.
Tranexamic acid (TXA), an antifibrinolytic drug, has been shown in large surgical trials to reduce risk of death in patients undergoing cesarean delivery or cardiac surgery. Incidence and severity of bleeding. Evidence from small trials suggests that tranexamic acid reduces the incidence and severity of bleeding in patients undergoing orthopaedic surgery. However, there are limited data on the use of tranexamic acid in non-orthopaedic, non-cardiac surgery patients. The current trial is not large enough to determine whether tranexamic acid increases the risk of thrombotic events in non-cardiac surgery patients.
Recently, the New England Journal published the results of the POISE-3 trial (Perioperative Ischemia Whether tranexamic acid was associated with a lower rate of life-threatening bleeding, major bleeding, or vital organ bleeding events compared to placebo in patients at risk of events, and efficacy and 30-day incidence of major cardiovascular complications safety. Let’s take a look together.
Methods
The POISE-3 trial included patients undergoing noncardiac surgery, Patients were randomized to: (1) tranexamic acid (1 g intravenously) or (2) placebo at the beginning and end of surgery.
Primary efficacy endpoint: life-threatening bleeding, major bleeding, or bleeding in a vital organ within 30 days (composite bleeding endpoint).
Primary safety endpoint: myocardial injury, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular endpoint) within 30 days of noncardiac surgery ).
To determine noninferiority of tranexamic acid versus placebo for the composite cardiovascular endpoint, the upper bound of the one-sided 97.5% confidence interval for the hazard ratio must be lower At 1.125, the one-sided P value must be less than 0.025.
Results
9,535 patients were randomized.
compound bleeding event endpoints,
methine Cyclic acid group: 433 (9.1%) of 4757 patients had a composite bleeding event;
placebo group: 561 (11.7%) of 4778 patients A compound bleeding event occurred.
hazard ratio 0.76; 95% confidence interval [CI] 0.67-0.87;
absolute difference, -2.6%; 95%CI -3.8- -1.4; two-sided P<0.001 was considered excellent.
composite cardiovascular endpoints,
ammonia Nexamic acid group: 649 of 4581 patients (14.2%) had a composite cardiovascular outcome event;
placebo group: 639 of 4601 patients A composite cardiovascular outcome event occurred in 13.9% of patients.
hazard ratio 1.02; 95%CI 0.92- 1.14; upper bound of one-sided 97.5%CI, 1.14;
Absolute difference, 0.3%; 95% CI -1.1- 1.7; one-sided P=0.04 indicates noninferiority.
Kaplan-Meier plot of primary endpoint
A Composite bleeding endpoint (life-threatening, major, or vital organ bleeding events within 30 days)
B Composite cardiovascular endpoint (myocardium after non-cardiac surgery within 30 days) injury, non-hemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolic events)
Conclusions strong>
The incidence of the composite bleeding endpoint was significantly lower in the tranexamic acid group than in the placebo group in patients undergoing non-cardiac surgery.
Non-inferiority of tranexamic acid was not established, although the between-group differences in composite cardiovascular outcomes were small.
Research Reviews
< span> The POISE-3 trial, one of the largest randomized controlled trials involving TXA in non-cardiac surgery, demonstrated that TXA intervention significantly reduced the composite event rate of life-threatening bleeding, major bleeding, and vital organ bleeding. Compared with placebo, TXA reduced the risk of bleeding by about 25%.
These results are consistent with previous findings from smaller trials and previous studies in non-cardiac surgical settings (postpartum, orthopedics, and trauma).
Although a meta-analysisshowed that TXA did not increase the risk of thromboembolic events, but the POISE-3 trial did not establish non-inferiority of TXA on cardiovascular safety endpoints. In addition, the use of TXA has also been associated with a reduction in the need for blood transfusions, which has led to a benefit in reducing blood product-related costs.
POISE-3 trial suggests that TXA use in non-cardiac elective surgery should be associated with fewer bleeding events (absolute difference -2.6%) and slightly increased cardiovascular events (0.3% absolute difference).
Source:
< span>Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med.2022. < span>doi: 10.1056/NEJMoa2201171.
ypertension. J Am Coll Cardiol 2022;79:1477–1488. doi:10.1016/j.jacc.2022.01.052
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