11, 1, 14, 17
Usual care alone, with rescue VA ECMO permitted
Early VA ECMO plus usual care
Unblinded. Crossover in the control arm dilutes the comparison. Population deliberately narrow. READ VIA SECONDARY SUMMARY (The Bottom Line) because NEJM is inaccessible from this environment — full author list, volume, pages and the precise endpoint definitions are unverified.
Adults with acute myocardial infarction complicated by cardiogenic shock undergoing revascularisation. Inclusion required ALL of: systolic BP under 90 mmHg for over 30 min or catecholamine dependence; signs of impaired organ perfusion; arterial lactate over 3 mmol/L; planned PCI or CABG. Excluded: over 45 min CPR pre-enrolment; mechanical or non-cardiac shock; shock onset over 12 h; severe peripheral vascular disease; age over 80; life-limiting illness. 877 screened, 420 enrolled, 417 in the ITT analysis.
30-day all-cause mortality
48% vs 49%; relative risk 0.98 (95% CI 0.80 to 1.19), p = 0.81. No difference in poor neurological outcome, renal replacement therapy, repeat revascularisation, time to stabilisation, or ICU/hospital stay. HARMS: limb ischaemia requiring intervention 11% vs 4%; moderate or severe bleeding 23% vs 10%. 28 control patients crossed over to VA ECMO.
It does NOT compare ECMO with no ECMO: controls could receive rescue ECMO, so it tests an early-unselective STRATEGY against a wait-and-rescue strategy. It says nothing about VA ECMO outside infarct-related shock — myocarditis, poisoning, massive PE, arrhythmic storm, post-cardiotomy failure, graft failure, hypothermia, or bridging to transplant or a durable device were excluded or never studied. Nor does it address patients over 80, those with severe peripheral vascular disease, or shock present for more than 12 hours.
Early, unselective VA ECMO in infarct-related cardiogenic shock does not reduce 30-day mortality, roughly doubles moderate-to-severe bleeding and nearly triples limb ischaemia requiring intervention. The largest single trial in this field and the anchor of the modern VA evidence base.