MANAGE
Management of myocardial injury After NoncArdiac surGEry trial
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 1,754 patients with myocardial injury after non-cardiac surgery, dabigatran 110 mg twice daily reduced major vascular complications without a significant increase in major bleeding compared with placebo.
N
1754
Disegno
Partial 2×2 factorial, double-blind, placebo-controlled RCT
Esito
Composite of vascular mortality, non-fatal MI, non-haemorrhagic stroke, arterial thrombosis, amputation and symptomatic venous thromboembolism
Rilevanza
2
Risultato11 % vs 15 % (HR 0.72; 95 % CI 0.55–0.93; p=0.0115). Life-threatening, major or critical-organ bleeding 3 % vs 4 % (HR 0.92; p=0.76).
Devereaux PJ, Duceppe E, Guyatt G, et al. Lancet. 2018;391(10137):2325-2334. 10.1016/S0140-6736(18)30832-8
Discussione e critica
Stopped early for lack of funding, with study drug permanently discontinued in about 45 % of patients in both arms, so the estimate is diluted and the modest p value rests on a truncated design. It remains the only randomised evidence of any therapeutic strategy for myocardial injury after non-cardiac surgery.