No reduction in mortality with ECLS for infarct-related cardiogenic shock

medwireNews: The use of extracorporeal life support (ECLS) alongside medical therapy does not mitigate the risk for 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock, findings indicate. In the ECLS-SHOCK trial, which was presented at the ESC Congress 2023 by Holger Thiele (Heart Center Leipzig, Germany) and published simultaneously in The New England Journal of Medicine, the all-cause mortality rate was 47.8% among 209 patients who received ECLS plus standard medical therapy and a comparable 49.0% among 208 patients given medical therapy alone. This lack of benefit is supported by an individual patient data meta-analysis conducted by the research team and published in The Lancet, which similarly showed no significant reduction in the 30-day mortality rate with the early use of ECLS, he told the audience in Amsterdam, the Netherlands. Thiele explained that the ECLS-SHOCK study was initiated because although the use of ECLS (also known as venoarterial extracorporeal membrane oxygenation) in cardiogenic shock has increased more than tenfold in the past decade, evidence for its use has come from just observational studies and three small randomized trials. The researchers recruited 420 patients with infarct-related cardiogenic shock categorized as stage C, D, or E on the Society for Cardiovascular Angiography and Interventions scale for whom early revascularization was planned. They found that “[t]he results of sensitivity analyses in the per-protocol and as-treated populations were similar to the findings in the primary analysis,” and there was also “[n]o material difference” between the ECLS and control groups with respect to the secondary outcomes, including the duration of intensive care treatment and acute kidney failure warranting renal replacement therapy, myocardial reinfarction, and rehospitalization for congestive heart failure within 30 days. However, ECLS was associated with more complications – in particular, the incidence of moderate or severe bleeding and peripheral ischemic vascular events warranting intervention was significantly higher among patients in the ECLS than control arm, at rates of 23.4% versus 9.6%, and 11.0% versus 3.8%, respectively, and corresponding relative risks of 2.44 and 2.86. The findings of the meta-analysis, which comprised data on 567 participants of four trials (including ECLS-SHOCK), were similar. The 30-day mortality rate did not differ significantly between the ECLS and control groups (odds ratio=0.93), but the risk for major bleeding was a significant 2.44-fold higher, while that for peripheral ischemic vascular complications was a significant 3.53-fold higher. Discussing the results, the investigators say that one reason for the absence of benefit of ECLS in cardiogenic shock could be that “the risk and associated device-related complications may counterbalance any potential benefit.” Another possible reason “could be that patients had poor outcomes that were not primarily related to circulatory failure,” they add. The authors of an editorial accompanying the trial publication say that “[i]f the goal of ECLS is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock.” Jane Leopold (Brigham and Women's Hospital, Boston, Massachusetts, USA) and Darren Taichman (Perelman School of Medicine, Philadelphia, Pennsylvania, USA) add that “[t]here will be some patients in this population for whom ECLS is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones.” And they conclude: “We need further studies to tell us who they are.” medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group ESC Congress 2023; Amsterdam, the Netherlands: 25–28 August N Engl J Med 2023; doi:10.1056/NEJMoa2307227 Lancet 2023; doi:10.1016/S0140-6736(23)01607-0 N Engl J Med 2023; doi:10.1056/NEJMe2309395

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No reduction in mortality with ECLS for infarct-related cardiogenic shock

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