Abstract
Background Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. Methods In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. Results A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P=0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). Conclusions In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).
| Original language | English |
|---|---|
| Journal | New England Journal of Medicine |
| Volume | 389 |
| Issue number | 14 |
| Pages (from-to) | 1286-1297 |
| Number of pages | 12 |
| ISSN | 0028-4793 |
| DOIs | |
| Publication status | Published - 05.2023 |
Funding
We conducted this investigator-initiated, randomized, multicenter, open-label trial in two European countries (Germany and Slovenia). The primary objective was to determine whether patients with acute myocardial infarction complicated by cardiogenic shock (defined as stage C, D, or E of the Society for Cardiovascular Angiography and Interventions [SCAI] criteria) with planned revascularization would benefit from early, unselective ECLS in addition to usual medical therapy as compared with usual medical therapy alone. The design of the trial has been published previously. The trial was supported by the Else Kröner Fresenius Foundation, the German Heart Research Foundation, and the Helios Health Institute (formerly Leipzig Heart Institute).