https://doi.org/10.55788/21eeafb2
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].
- 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.
- 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.
- Devereaux PJ, et al. N Engl J Med 2022; 386:1986-1997.
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Table of Contents: ACC 2022
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