Home > Cardiology > ACC 2022 > Highlighted Original Research > POISE-3: Tranexamic acid for non-cardiac surgery

POISE-3: Tranexamic acid for non-cardiac surgery

Presented By
Prof. Philip Devereaux; Dr Maura Marcucci, McMaster University, Canada
ACC 2022
Phase 3, POISE-3
The international, multicentre, randomised POISE-3 clinical trial compared both the use of antifibrinolytic tranexamic acid (TXA) with placebo as well as the effect of strategies to avoid hypotension versus hypertension in patients undergoing non-cardiac surgery who are at risk of a perioperative cardiovascular event.

Prof. Philip Devereaux (McMaster University, Canada) and Dr Maura Marcucci (McMaster University, Canada) presented the POISE-3 study (NCT03505723), which randomised patients undergoing non-cardiac surgery to receive either 1 g intravenous bolus of TXA or placebo at the start and end of surgery [1,2]. Using a 2 X 2 factorial design, the study also assessed the impact of a hypotensive-avoidance strategy versus a hypertension-avoidance strategy in the patients who were on antihypertensive medication [2].

The primary efficacy endpoint for the evaluation of TXA was a composite bleeding outcome comprising life-threatening bleeding, major bleeding, or bleeding into a critical organ by 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 by 30 days [1]. These results were simultaneously published in the New England Journal of Medicine [3]. 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 [2].

A total of 9,535 patients were randomised 1:1 to TXA or placebo group. After 1 month, a composite bleeding event occurred in 9.1% in the TXA group and 11.7% in the placebo group (HR 0.76; 95% CI 0.67–0.87; P<0.001; see Figure); yet, there was no difference in the safety composite cardiovascular endpoint: events occurred in 14.2% in the TXA arm and 13.9% of the placebo group (HR 1.02; 95% CI 0.92–1.14; P=0.04 for non-inferiority).

Figure: The composite bleeding outpoint of POISE-3 [1]

CI, confidence interval; HR, hazard ratio; TXA, tranexamic acid.

The blood-pressure part of the study randomised 7,490 patients on at least one antihypertensive medication 1:1 to a hypotensive-avoidance strategy or hypertension-avoidance strategy [2]. The occurrence of major vascular complications after 30 days was similar for participants who were randomised to a hypotension-avoidance strategy (13.9%) and those who underwent a hypertension-avoidance strategy (14.0%; HR 0.99; P=0.92). Importantly, the blood-pressure management factorial had no significant effect on the results of the comparison between tranexamic acid and placebo for the primary efficacy outcome (Pinteraction=0.67 for interaction) and the primary safety outcome (Pinteraction=0.74).

Prof. Devereux concluded that among patients undergoing non-cardiac surgery, the incidence of the composite bleeding outcome was significantly lower with TXA than with placebo, with no significant safety burden observed in the current study [1]. Furthermore, in patients who were on antihypertensive agents, using either a perioperative hypotension-avoidance strategy or a hypertension-avoidance strategy resulted in similar rates of major vascular complications [2].

    1. Devereaux PJ, et al. Efficacy And Safety Of Tranexamic Acid In Patients Undergoing Noncardiac Surgery: The Poise-3 Trial. Abstract 402–13, ACC 2022, 2–4 April, Washington DC, USA.

    2. Marcucci M, et al. The effects of a hypotension-avoidance strategy versus hypertension-avoidance strategy in patients undergoing noncardiac surgery. Abstract 409–10, ACC 2022, 2-4 April, Washington DC, USA.

    3. Devereaux PJ, et al. N Engl J Med 2022; 386:1986-1997.


Copyright ©2022 Medicom Medical Publishers

Posted on