ECLS in Cardiogenic Shock: New Trial Reveals No Survival Advantage, Highlights Safety Concerns
Germany: Extracorporeal life support (ECLS), a treatment increasingly employed for infarct-related cardiogenic shock, has raised questions about its impact on mortality due to the lack of evidence. A recent multicenter trial published in the New England Journal Of Medicine by Holger Thiele and colleagues aimed to address this uncertainty by investigating the effects of early ECLS in patients with acute myocardial infarction complicated by cardiogenic shock.
The study suggested that for patients with acute myocardial infarction complicated by cardiogenic shock and early planned revascularization, the addition of ECLS therapy did not result in a lower risk of all-cause mortality at the 30-day follow-up compared to those receiving medical therapy alone.
The trial involved 420 patients who were randomly assigned to receive either early ECLS in addition to usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome measured was all-cause mortality at 30 days. Safety outcomes, including bleeding, stroke, and peripheral vascular complications requiring intervention or surgery, were also assessed.
• After analyzing the data from 417 patients who were included in the final analysis, the results revealed that the rate of death from any cause at the 30-day mark was comparable between the two groups.
• In the ECLS group, 47.8% of patients experienced mortality, while the control group reported a mortality rate of 49.0%.
• The relative risk of death between the two groups was 0.98, with a confidence interval of 0.80 to 1.19, showing no significant difference in outcomes.
• Secondary outcomes highlighted the safety concerns associated with ECLS.
• Patients in the ECLS group demonstrated a higher incidence of moderate or severe bleeding (23.4% vs. 9.6% in the control group) and peripheral vascular complications requiring intervention (11.0% vs. 3.8% in the control group).
Meanwhile, "the best course may be to reserve the early initiation of ECLS for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms," wrote Jane A. Leopold, MD, of Brigham and Women's Hospital in Boston, and Darren B. Taichman, MD, PhD, of the University of Pennsylvania in Philadelphia
In conclusion, the trial suggested that for patients with acute myocardial infarction complicated by cardiogenic shock and early planned revascularization, the addition of ECLS therapy did not result in a lower risk of all-cause mortality at the 30-day follow-up compared to those receiving medical therapy alone. The findings emphasize the need for further research and consideration of safety concerns when utilizing ECLS in this patient population.
Reference:
New England Journal of Medicine Thiele H, et al "Extracorporeal life support in infarct-related cardiogenic shock" N Engl J Med 2023; DOI: 10.1056/NEJMoa2307227.
