December 15, 2019
Enrollment Begins in STEMI DTU Pivotal Trial of Abiomed's Impella Heart Pump
December 16, 2019—Abiomed announced the initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial (RCT).
According to the company, STEMI DTU will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump before opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates.
The study is designed to enroll 668 patients undergoing treatment for STEMI at up to 60 sites. Half the patients will be randomized to receive 30 minutes of left ventricular unloading with the Impella CP heart pump before reperfusion. The other half will receive immediate reperfusion, the current global standard of care. The primary endpoint is infarct size as a percent of the left ventricular mass, measured at 3 to 5 days using cardiac MRI.
The first patient in the multicenter trial was enrolled by Kevin Wolschleger, MD, an interventional cardiologist at Spectrum Health in Grand Rapids, Michigan. In the company’s announcement, Dr. Wolschleger commented, “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.”
David Wohns, MD, Chief of Cardiology at Spectrum Health, added, “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.”
Navin Kapur, MD, the study’s Co-Principal Investigator, stated, “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. 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.” Dr. Kapur is Executive Director of the CardioVascular Center for Research and Innovation at Tufts Medical Center in Boston, Massachusetts.