POISE-3: Tranexamic acid for non-cardiac surgery

The POISE-3 clinical trial compared the use of antifibrinolytic tranexamic acid with placebo and investigated the effect of managing hypotension versus standard of care (i.e. hypertension) 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 the difference in composite cardiovascular complications between the tranexamic acid group and the placebo group was small, 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 patients undergoing non-cardiac surgery to receive either 1 g intravenous bolus of tranexamic acid or placebo at the start and end of surgery [1]. A total of 9,535 patients were randomised 1:1 to tranexamic acid or placebo group. The primary efficacy endpoint 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 [1]. The primary outcome for the blood pressure part of the study was a composite of vascular death and non-fatal myocardial injury after surgery, stroke, and cardiac arrest 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); yet, there was no difference in the safety composite cardiovascular endpoint: events occurred in 14.2% in the tranexamic acid arm and 13.9% of the placebo group (HR 1.02; 95% CI 0.92–1.14; P=0.04 for non-inferiority).

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].

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 19 May, 2022