Early extracorporeal life support (ECLS) does not improve survival in patients with acute myocardial infarction (MI) complicated by cardiogenic shock who are scheduled for early revascularisation.
This was the headline finding from the ECLS-SHOCK trial, presented during a Hot Line session at the European Society of Cardiology (ESC) congress (25–28 August, Amsterdam, The Netherlands). According to the trial’s principal investigator, Holger Thiele (Leipzig Heart Centre, Leipzig, Germany), the findings may lead to the discontinuation of the routine use of ECLS therapy in clinical practice.
ECLS-SHOCK was the first randomised trial to investigate the effect of ECLS on mortality in patients with acute myocardial infarction complicated by cardiogenic shock.
A total of 420 patients with acute myocardial infarction and cardiogenic shock scheduled for early revascularisation were enrolled from 44 centres in Germany and Slovenia. The median age of participants was 63 years and 19% were women. Patients were randomly assigned to early ECLS plus usual medical treatment (ECLS group) or to usual medical treatment alone (control group).
The trial’s primary endpoint was all-cause death at 30 days, whilst secondary endpoints included length of mechanical ventilation, time to haemodynamic stabilisation and need for renal replacement therapy. Safety endpoints included moderate or severe bleeding and peripheral vascular complications requiring intervention
A total of 417 patients were included in the final analyses, in which it was reported that the primary endpoint of all-cause death at 30 days occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49%) in the control group.
The median duration of mechanical ventilation was longer in the ECLS group: seven days in the ECLS group versus five days in the control group. The time to haemodynamic stabilisation and rates of renal replacement therapy were similar between treatment groups.
Regarding safety endpoints, Thiele reported that moderate or severe bleeding occurred more frequently in the ECLS group: 23.4% of patients in the ECLS group versus 9.6% of patients in the control group, and peripheral vascular complications requiring intervention occurred also more often in the ECLS group: 11% of patients in the ECLS group versus 3.8% of patients in the control group.
“The results of ECLS-SHOCK demonstrated no reduction in 30-day mortality with early ECLS therapy and an increase in complications,” Thiele said. “The findings may lead to the discontinued routine use of these devices in clinical practice.”
