POISE-3: Tranexamic acid for non-cardiac surgery

The POISE-3 clinical trial compared the use of antifibrinolytic tranexamic acid with placebo in patients undergoing non-cardiac surgery who are at risk of a peri-operative cardiovascular event. The efficacy endpoint favours a wider use of tranexamic acid at the start and end of non-cardiac surgery. Although a small difference in composite cardiovascular complications between the tranexamic acid group and the placebo group was observed, the non-inferiority of tranexamic acid was not established, making it a new option for patients.

Prof. Philip Devereaux (McMaster University, Canada) presented the international, multicentre, randomised POISE-3 study (NCT03505723) during the late-breaking session for high-impact publications in critical care, as the results were just recently published in the New England Journal of Medicine [1,2]. POISE-3 randomised 9,535 patients undergoing non-cardiac surgery 1:1 to receive either 1 g intravenous bolus of tranexamic acid or placebo at the start and end of surgery [1]. The primary efficacy endpoint for the evaluation of tranexamic acid was a composite bleeding outcome comprising life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days. The primary cardiovascular safety endpoint was a composite cardiovascular outcome, comprising myocardial injury after non-cardiac surgery, non-haemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days.

After 1 month, a composite bleeding event occurred in 9.1% in the tranexamic acid group and 11.7% in the placebo group (HR 0.76; 95% CI 0.67–0.87; P<0.001). Additionally, there was no difference in the safety composite cardiovascular endpoint: events occurred in 14.2% of the tranexamic acid arm and 13.9% of the placebo group (HR 1.02; 95% CI 0.92–1.14; P_{non-inferiority}=0.04).

Prof. Devereaux concluded that among patients undergoing non-cardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo, with no significant safety burden associated with this treatment.

1. Devereaux PJ, et al. Efficacy And Safety Of Tranexamic Acid In Patients Undergoing Noncardiac Surgery: The Poise-3 Trial. Session A84, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.
2. Devereaux PJ, et al. N Engl J Med 2022; Apr 02. DOI: 10.1056/NEJMoa2201171.

 

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Posted on 18 July 2022