Results of a new per-protocol analysis of data from the ST-segment Elevation Myocardial Infarction Door-To-Unload (STEMI DTU) pilot trial show a significant reduction in infarct extent in patients who received a left ventricular unloading with Impella CP for 30 minutes prior to their percutaneous coronary intervention (PCI), compared to patients who received left ventricular unloading immediately followed by PCI. The data was presented today during the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston by Navin K. Kapur, MD, executive director of the Cardiovascular Center for Research and Innovation (CVCRI) at Tufts Medical Center, and principal investigator of the pivotal randomized controlled STEMI DTU trial.
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The STEMI DTU pilot trial demonstrated for the first time that LV unloading using the Impella CP® heart pump with a 30-minute delay before reperfusion is safe and feasible. (Graphic: BusinessWire)
The new analysis compared infarct extent in 32 patients in the pivotal STEMI DTU trial who met all inclusion and exclusion criteria. All patients had ST-segment elevation myocardial infarction (STEMI) and followed one of two treatment protocols: left ventricular unloading with Impella CP immediately followed by PCI (n=15), or left ventricular unloading with Impella CP for 30 minutes before PCI (n=17). Magnetic resonance cardiac imaging performed between three and five days after PCI was used to determine the extent of infarction normalized to the area at risk. The results showed that the infarct extent normalized to the area at risk was significantly reduced in the delayed PCI group, compared to the immediate PCI group (infarct extent/area at risk: 47±16 vs 60±16, p=0.02), resulting in a relative (22%) and absolute (13%) reduction in the extent of the infarction/area at risk.
“The results of this analysis are preliminary, but promising. They indicate that for STEMI patients, left ventricular unloading with Impella CP for 30 minutes prior to PCI could potentially help improve patient outcomes by reducing heart muscle damage and helping to prevent heart failure,” states Dr Capur.
Myocardial damage can lead to heart failure. Each 5% increase in infarct size is associated with a 20% increase in the relative risk of death or hospitalization from any cause for heart failure in the year following primary PCI (JACC, 2016). Coronary artery disease is the leading cause of death in the United States and 47% of women and 36% of men over the age of 45 die within five years of their first heart attack (Traffic, 2019).
The STEMI DTU pilot study demonstrated for the first time that left ventricular unloading with Impella CP with a 30-minute delay of reperfusion via PCI is feasible, safe, and not associated with an increase in infarct size. The pilot study led to the pivotal randomized controlled STEMI DTU trial, which started in 2019 and is actively recruiting patients. The pivotal trial tests the hypothesis that, compared to PCI alone, left ventricular unloading for 30 minutes prior to PCI can reduce myocardial damage and future heart failure events caused by heart attack.
ABOUT IMPELLA HEART PUMPS
Impella 2.5® and Impella CP® with SmartAssist® are approved by the US FDA to treat certain patients with advanced heart failure undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or angioplasty by balloon, to reopen blocked coronary arteries.
Impella 2.5, Impella CP®, Impella CP with SmartAssist, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are approved by the US FDA to treat patients with heart attack or cardiomyopathy in cardiogenic shock and have the unique ability to enable native cardiac recovery, allowing patients to return home with their own heart.
Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a medical technology leader providing circulatory support and oxygenation solutions. Our products are designed to allow the heart to rest by improving blood flow and/or providing sufficient oxygenation to people with respiratory failure. For more information, visit abiomed.com.
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