The data was presented at the American College of Cardiology conference and published it in the New England Journal of Medicine. The study evaluated patients who had a heart attack with ST-elevation myocardial infarction (STEMI) cardiogenic shock. It confirmed that Impella CP reduced 180-day mortality by 12.7% compared to the control arm (45.8% vs. 58.5%).
The study also saw an increased risk of adverse events. Investigators say this does not overshadow the benefit of treatment with the Impella CP microaxial flow pump.
The Danish German Cardiogenic Shock Trial (DanGer Shock) trial represents the first mechanical circulatory support device randomized controlled trial to demonstrate a survival benefit in AMI cardiogenic shock patients, Abiomed said in a news release. It enrolled 360 participants at 14 sites in Denmark, Germany and the UK between 2013 and 2023.
“We congratulate Dr. Møller and the independent group of investigators who initiated and completed this landmark trial,” said Dr. Chuck Simonton, EVP and chief medical officer, Abiomed. “What impresses me most is that the significant survival benefit with Impella, compared to the control arm, improves over time.”
