Routine use of the Impella CP (Abiomed) micro-axial flow pump in the treatment of patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock leads to an absolute mortality reduction of 16.3% when compared to standard care at 10 years, long-term data from the DANGER-SHOCK trial have shown.
These findings from the long-term follow up of patients in the investigator-initiated DanGer Shock randomised controlled trial (RCT) were presented at the 2025 European Society of Cardiology (ESC) congress (29 August – 1 September, Madrid, Spain) by the trial’s principal investigator, Jacob Møller (Odense University Hospital, Odense, Denmark) and simultaneously published in the New England Journal of Medicine. The data also demonstrated that compared to the control arm at 10 years, patients treated with the device gained an average of 600 additional days alive.
The absolute mortality reduction of 16.3% at up to 10 years is an increase from the initial six-month data, which found routine use of Impella CP reduced the absolute risk of mortality by 12.7%2. The trial enrolled 360 participants at 14 sites in Denmark, Germany and the United Kingdom between 2013–2023.
Previous trials evaluating the potential benefits of this and other heart pumps for cardiogenic shock have had mixed results. DANGER-SHOCK is the first trial powered to examine whether the use of the device can improve survival in STEMI complicated by cardiogenic shock.
“The long-term data from the DanGer Shock RCT released today validates the original findings and confirms that the survival benefit of Impella CP is durable and increases year-over-year,” said Navin Kapur, chief medical and scientific officer for heart recovery, J&J MedTech in a press release issued by the company following the presentation at ESC.
The American College of Cardiology (ACC) and American Heart Association (AHA) upgraded Impella to a class 2a guideline based on the original DanGer Shock RCT data presented at the ACC scientific session in May 2024.
