POISE-3

PeriOperative ISchemic Evaluation-3 trial

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 9,535 patients undergoing non-cardiac surgery at risk of bleeding and cardiovascular events, intravenous tranexamic acid reduced life-threatening, major or critical-organ bleeding at 30 days, but non-inferiority for the cardiovascular safety composite was not established compared with placebo.

9535

Disegno

Partial factorial, double-blind, placebo-controlled RCT

Esito

Composite bleeding outcome at 30 days; safety composite of myocardial injury, stroke, arterial thrombosis or venous thromboembolism

Rilevanza

RisultatoBleeding 9.1 % vs 11.7 % (HR 0.76; 95 % CI 0.67–0.87; p<0.001). Cardiovascular composite 14.2 % vs 13.9 % (HR 1.02; 95 % CI 0.92–1.14), missing the prespecified non-inferiority margin.

Devereaux PJ, Marcucci M, Painter TW, et al. N Engl J Med. 2022;386(21):1986-1997. 10.1056/NEJMoa2201171

Discussione e critica

Non-inferiority for cardiovascular safety formally failed, so a small thrombotic hazard cannot be excluded, and the separately reported blood-pressure-management comparison was neutral. It is by far the largest antifibrinolytic trial in non-cardiac surgery and establishes tranexamic acid as a bleeding-reduction strategy with an explicit thrombotic caveat.