A pivotal, multi-center clinical trial to explore a promising new therapy to reduce heart failure rates by changing the way heart attack patients are treated is now underway. The first patient has enrolled in the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The first enrollment took place at Spectrum Health in Grand Rapids, Mich. The trial will test the hypothesis that unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce myocardial damage from a heart attack and lead to a reduction in future heart failure rates.
 
“With the aging population and rising rates of heart failure, the research being conducted in this trial has the potential to be far reaching and meaningful. If successful, it could lead to a paradigm change in the way heart attack patients are treated,” said David Wohns, M.D., chief of cardiology at Spectrum Health.
 
Heart failure is a major health problem in the United States. A study published in October 2019 in JAMA Cardiology found deaths from heart failure increased 38 percent from 2011 to 2017 and concluded that, “innovative and effective approaches to prevent and treat heart disease, particularly the substantially increasing rates of heart failure, are needed.”
 
A report in the journal Circulation determined 47 percent of women and 36 percent of men over the age of 45 will die within five years of their first heart attack. Additionally, research published in Journal of the American College of Cardiology found 75 percent of patients experiencing their first heart attack will develop heart failure within five years. If the STEMI DTU pivotal 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.
 
“Patients with large anterior myocardial infarction continue to have unacceptably high rates of death and heart failure despite successful primary PCI. The STEMI DTU trial will demonstrate whether Impella unloading of the left ventricle prior to reperfusion therapy reduces infarct size and thereby improves the prognosis of this high-risk patient cohort,” said Gregg W. Stone, M.D., a STEMI DTU steering committee member, professor of medicine, professor of population health sciences and policy and director of academic affairs for the Mount Sinai Heart Health System, and co-director of medical research and education at The Cardiovascular Research Foundation.
 
The multi-center, two-arm randomized controlled trial (RCT) plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive 30 minutes of left ventricular unloading with the U.S. Food and Drug Administration (FDA)-approved Impella CP heart pump prior to having blood flow restored to their blocked arteries. The other half will receive immediate reperfusion, the current standard of care. The primary endpoint is infarct size as a percent of left ventricular mass, measured at three to five days using cardiac MRI.
 
A pilot safety RCT successfully demonstrated a therapy of 30 minutes of unloading with Impella prior to reperfusion is safe and feasible. The pilot trial results were announced as a late-breaking study at the American Heart Association (AHA) 2018 Scientific Sessions and simultaneously published in Circulation.
 
“The STEMI DTU Pivotal Trial opens an entirely new chapter in heart attack management,” said Navin Kapur, M.D., STEMI DTU co-principal investigator and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center. “Based on extensive preclinical research conducted in laboratories around the world and the STEMI-DTU Pilot Trial results, the pivotal trial will definitively test the hypothesis that reducing the workload of the heart – known as ventricular unloading – for 30 minutes before opening a blocked artery reduces heart damage and recovers heart function more effectively than opening the blocked artery alone.”
 
The pivotal trial will be overseen by a steering committee of five expert cardiologists and clinical trialists. They are: Dr. Kapur, Dr. Stone, William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Jeffrey Moses, M.D., professor of medicine at Columbia University Medical Center and director of interventional cardiovascular therapeutics at Columbia University Medical Center, and James Udelson, M.D., chief of the division of cardiology at Tufts Medical Center.
 
The study is funded by Abiomed.
 
The ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial enrolled its first patient in December 2019 and will test the hypothesis that, in patients experiencing a STEMI heart attack, 30 minutes of unloading with Impella CP prior to reperfusion will reduce myocardial damage and reduce future risk of heart failure. The trial plans to enroll 668 subjects at up to 60 sites, with two additional “roll-in” patients at each site to test the study protocol before beginning enrollment. The trial allows for an adaptive design, which permits adjustments to the study sample size after an interim analysis. Information on the study endpoints and inclusion criteria is available on ClinicalTrials.gov.
 
The Impella 2.5 and Impella CP devices are FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with Smart Assist are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP is FDA-approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Impella is the most studied mechanical circulatory support device in the history of the FDA with more than 10 years of FDA studies, real world clinical data on more than 100,000 patients and more than 550 peer-reviewed publications.
 
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to five days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with Smart Assist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia.