Trial | N | Comparator | Chapters | Limitations | Primary endpoint | Intervention | What it tells us | Year | Population | What it does NOT tell us | Verified | Link | ECMO type | Result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
30 | Standard ACLS | 1, 19, 20 | Single centre, phase 2, 30 patients, stopped early at an efficacy boundary. Highly selected population within a mature, high-volume ECPR system. Early stopping inflates effect size. | Survival to hospital discharge | Early ECMO-facilitated resuscitation | Within a mature single-centre system, an ECMO-facilitated pathway for refractory shockable OHCA produced a large survival difference. | 2020 | Out-of-hospital cardiac arrest with refractory ventricular fibrillation or pulseless VT, no ROSC after three shocks, age 18-75 | It does not establish generalisability to other systems, and the effect estimate should be regarded as an upper bound. | ECPR | 6/14 (43%) vs 1/15 (7%); posterior probability of ECMO superiority 0.9861, crossing the prespecified 0.986 efficacy boundary | |||
417 | Usual care alone | 1, 11, 14, 15 | Open-label; crossover to ECMO in the control arm; confined to infarct-related shock in revascularised patients. | All-cause death at 30 days | Early VA ECMO plus usual care | Routine early VA ECMO in infarct-related cardiogenic shock does not reduce 30-day mortality and roughly doubles major bleeding and limb ischaemia. | 2023 | Acute myocardial infarction complicated by cardiogenic shock, planned early revascularisation | It says nothing about non-infarct cardiogenic shock, ECPR, rescue cannulation in refractory shock, or LV unloading strategies. | VA | 48% vs 49%; RR 0.98 (95% CI 0.80-1.19), p=0.81. Moderate/severe bleeding 23% vs 10%; limb ischaemia requiring intervention 11% vs 4%. | |||
117 | Early conservative strategy with ECMO permitted as rescue | 1, 11, 14 | Small; 23/59 (39%) of the conservative arm received downstream VA ECMO, of whom 52% died. Composite endpoint includes MCS escalation, which favours the immediate-ECMO arm by construction. | Composite of death from any cause, resuscitated circulatory arrest, or implementation of another mechanical circulatory support at 30 days | Immediate VA ECMO | An immediate VA ECMO strategy did not improve a 30-day composite outcome compared with early conservative management with rescue ECMO available. | 2023 | Rapidly deteriorating or severe cardiogenic shock, SCAI stage D-E | It is not powered for mortality and does not address non-infarct phenotypes or the timing of rescue cannulation. | VA | 63.8% (37/58) vs 71.2% (42/59); risk difference -7.4% (95% CI -24.3 to 9.5) | |||
160 | Conventional CPR | 1, 19, 20, 21 | Only 46/70 (66%) of patients allocated to ECPR were successfully cannulated. Multicentre with variable institutional ECPR experience; long low-flow times. | Survival with favourable neurological outcome (CPC 1-2) at 30 days | Extracorporeal CPR | In a multicentre setting with mixed institutional experience, an ECPR strategy did not significantly improve 30-day neurologically favourable survival. | 2023 | Refractory out-of-hospital cardiac arrest with an initial shockable rhythm, witnessed, age 18-70 | With one third of the intervention arm never cannulated, it tests an ECPR pathway rather than ECPR itself, and cannot exclude benefit in systems with higher cannulation success and shorter time to flow. | ECPR | 20% (14/70) vs 16%; OR 1.4 (95% CI 0.5-3.5), p=0.52. 160 randomised, 134 in the primary analysis. | |||
249 | Conventional management with ECMO permitted as rescue | 1, 4, 7 | Stopped for futility at 75% of planned enrolment. 35/125 (28%) of controls crossed over to rescue ECMO; 20/35 (57%) of those died. | All-cause mortality at 60 days | Immediate VV ECMO | Early ECMO in very severe ARDS produced an 11 percentage point absolute mortality difference that did not reach conventional significance in an underpowered trial. | 2018 | Very severe ARDS: PaO2/FiO2 <50 for >3 h, or <80 for >6 h, or pH <7.25 with PaCO2 >60 for >6 h | It does not compare ECMO with no ECMO. With 28% crossover the trial compares early ECMO against rescue ECMO, and therefore cannot exclude a clinically important benefit. | VV | 35% (44/124) vs 46% (57/125); RR 0.76 (95% CI 0.55-1.04), p=0.09 | |||
256 | Standard resuscitation on scene | 1, 19, 20, 23 | Stopped for futility at a prespecified interim analysis. Tests a whole bundle rather than ECPR alone; single high-performing system. | Survival with CPC 1-2 at 180 days | Invasive bundle: intra-arrest transport, ECPR if no ROSC within 60 minutes, immediate invasive assessment and treatment | An invasive intra-arrest bundle including ECPR produced a directionally favourable but statistically non-significant improvement in 180-day neurologically favourable survival. | 2022 | Refractory out-of-hospital cardiac arrest of presumed cardiac cause | It cannot attribute any of the observed difference specifically to the extracorporeal circuit rather than to intra-arrest transport or immediate invasive assessment. | ECPR | 31.5% vs 22.0%; absolute difference 9.5% (95% CI -1.3 to 20.1), p=0.09 | |||
567 | Optimal medical therapy without routine early VA ECMO | 1, 11, 17 | Four trials, 284 VA-ECMO and 283 control patients; all open-label; restricted to infarct-related shock. | All-cause death at 30 days | Early VA ECMO | At individual patient data level there is no mortality signal for routine early VA ECMO in infarct-related cardiogenic shock, and a consistent harm signal for bleeding and limb ischaemia. | 2023 | Pooled individual patient data from randomised trials of early VA ECMO in infarct-related cardiogenic shock | It cannot identify a responder subgroup that was not represented in the constituent trials, and it does not address rescue use or non-infarct phenotypes. | VA | OR 0.93 (95% CI 0.66-1.29); no benefit in any prespecified subgroup (p for interaction >=0.079). Major bleeding OR 2.44 (1.55-3.84); peripheral ischaemic vascular complications OR 3.53 (1.70-7.34). | |||
180 | Continued conventional management at the referring centre | 1, 4, 7 | Randomised to referral, not to ECMO: only 68/90 (76%) of the referral arm actually received ECMO. Control arm had no protocolised lung-protective ventilation. Single ECMO centre. | Death or severe disability at 6 months | Referral and transfer to a single specialist ECMO centre | A pathway of transfer to a specialist ECMO centre improved 6-month death-or-severe-disability compared with conventional management as delivered in 2001-2006. | 2009 | Adults with severe but potentially reversible respiratory failure (Murray score >3 or pH <7.20) | It does not isolate the effect of the ECMO circuit itself, and it does not describe a comparison against modern protocolised lung-protective ventilation. | VV | 37% (33/90) vs 53% (46/87); RR 0.69 (95% CI 0.05-0.97), p=0.03 |