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Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates. The first patient in the multi-center trial was enrolled at Spectrum Health in Grand Rapids, Michigan, by Kevin Wolschleger, MD.

“We are honored to be the first to enroll in this important study which builds on earlier research that shows promise for slowing the growing epidemic of heart failure and improving outcomes for heart attack patients around the world.” said Dr. Wolschleger, an interventional cardiologist at Spectrum Health.

“Spectrum Health has one of the longest Impella experiences in the United States, and we are proud and excited to be a part of this pivotal clinical trial that has the promise to bring this paradigm changing therapy to patients,” said David Wohns, MD, chief of cardiology at Spectrum Health.

The STEMI DTU RCT is the fourth completed or ongoing randomized controlled trial of Impella, following:

• The successfully completed PROTECT II RCT, which demonstrated Impella is safe and effective compared to the intra-aortic balloon pump (IABP) (Circulation, 2012; FDA Press Release, 2015)
• The successfully completed STEM DTU pilot RCT, which demonstrated 30 minutes of unloading prior to reperfusion in STEMI patients is safe and feasible (Circulation, 2018)
• The ongoing DanGer Shock RCT of AMI cardiogenic shock patients, which compares patients receiving Impella to conventional therapy (American Heart Journal, 2019)

Impella is the most studied mechanical circulatory support device in the history of the FDA. The FDA granted Impella its highest level of regulatory approval based on the PROTECT II randomized controlled trial and multiple other FDA audited prospective trials that demonstrate Impella’s safety and efficacy, compared to the intra-aortic balloon pump (IABP). When compared to other mechanical circulatory support devices, Impella has the best overall safety profile for stroke, aortic valve damage, vascular complications, major bleeding and hemolysis.

The STEMI DTU RCT plans to enroll 668 patients undergoing treatment for a STEMI heart attack at up to 60 sites. The study will have two arms. Half the patients will be randomized to receive 30 minutes of left ventricular unloading with the Impella CP heart pump prior to reperfusion. The other half will receive immediate reperfusion, the current global standard of care. The primary endpoint is infarct size as a percent of left ventricular mass, measured at 3-5 days using cardiac MRI.

A study that published in JAMA Cardiology in October found deaths from heart failure increased 38 percent between 2011 and 2017. If the STEMI DTU trial successfully concludes, it could annually benefit 200,000 heart attack patients in the United States and more than 4 million patients outside the United States.

“If the STEMI DTU pivotal RCT confirms earlier research, it could lead to a paradigm shift in the way STEMI heart attack patients are treated,” said Navin Kapur, MD, the study’s co-principal investigator and the executive director of the CardioVascular Center for Research and Innovation (CVCRI) at Tufts Medical Center. “This is the first-ever pivotal trial to examine delayed reperfusion and ventricular unloading as a therapy to slow the growing epidemic of heart failure and improve the standard of care for these patients. On behalf of the study investigators, we are excited this trial is underway and eagerly anticipate the results.”

See Full Press Release: First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness | Business Wire

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Written by:  Abiomed

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