August 26, 2023
Extracorporeal Life Support in Infarct-Related Cardiogenic Shock
What was the research question?
Population: Patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned.
Intervention: Early extracorporeal life support (ECLS) plus usual medical treatment.
Comparison: Usual medical treatment alone.
Outcome: Death from any cause at 30 days, safety outcomes including bleeding, stroke, and peripheral vascular complications requiring interventional or surgical therapy.
How did they do it?
Study Design: Multicenter, randomized controlled trial.
Participants: A total of 420 patients underwent randomization, and 417 were included in the final analyses. 209 patients were assigned to the ECLS group, and 208 patients to the control group.
Primary Outcome: Death from any cause at 30 days.
Secondary Outcomes: Duration of mechanical ventilation, incidence of moderate or severe bleeding, and peripheral vascular complications requiring intervention.
What were the results?
At 30 days, death from any cause occurred was not significantly different between the two groups (47.8% in the ECLS group vs 49.0% in the control group: RR 0.98; 95% confidence interval [CI], 0.80 to 1.19; P=0.81).
The median duration of mechanical ventilation was longer in the ECLS group (7 days) compared to the control group (5 days), and there was a significantly higher incidence of moderate or severe bleeding (23.4% vs. 9.6%; relative risk, 2.44; 95% CI, 1.50 to 3.95) and peripheral vascular complications requiring intervention (11.0% vs. 3.8%; relative risk, 2.86; 95% CI, 1.31 to 6.25) in the ECLS group.
Are there any limitations of the study?
Blinding of the intervention was not possible, which may have influenced the therapeutic decisions of treating physicians.
There was a crossover of 39 patients from their assigned group to the other group, which might have influenced the results.
Inclusion of centers with both medium and high volumes of ECLS use could have influenced outcomes due to differences in device operation experience.
The study population was heterogeneous in terms of clinical presentation and course.
What does it mean?
The trial demonstrated that early routine ECLS was not superior to usual medical therapy alone in reducing death from any cause at 30 days in patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization. Additionally, ECLS was associated with a higher incidence of complications, particularly bleeding and peripheral vascular events.
This study adds to the existing body of evidence suggesting that the risks and device-related complications of ECLS may counterbalance any potential benefits in patients with cardiogenic shock.
Clinicians should weigh the risks and benefits of ECLS carefully and consider the potential complications associated with its use.
More research is needed to identify subgroups of patients with cardiogenic shock who may benefit from ECLS and to optimize its use to minimize complications.