After a successful safety and feasibility trial run, the FDA granted approval April 26 to the STEMI DTU (ST-Elevation Myocardial Infarction Door-to-Unloading) study, which will examine whether unloading the left ventricle prior to reperfusion can reduce myocardial damage and lead to fewer CV complications in STEMI patients.
STEMI DTU will be a prospective, multi-center, two-arm trial among 668 patients undergoing treatment for STEMI, according to a release. Half the patients will be randomized to receive immediate perfusion—the current standard of care—while the other half will undergo delayed reperfusion after 30 minutes of left ventricular (LV) unloading with Abiomed’s Impella CP.
The trial is testing whether 30 minutes of LV unloading might minimize the myocardial damage many STEMI patients experience after reperfusion. That kind of damage can trigger an infarct, and every 5% increase in infarct size is linked to a 20% relative hazard for all-cause mortality or hospitalization for heart failure within a year of primary percutaneous coronary intervention.
“The STEMI DTU Pivotal Trial has the potential to improve the standard of care, slow the growing epidemic of heart failure and improve outcomes for millions of heart attack patients,” Navin Kapur, MD, executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center and the trial’s co-principal investigator, said in the release. “This trial is the first of its kind to focus on ventricular unloading as part of a therapeutic approach for heart attacks without cardiogenic shock and could lead to a paradigm shift in the way heart attack patients are treated worldwide.”
Kapur’s team will enroll patients from up to 60 sites starting in October, with recruitment persisting through 2022 or 2023. The study’s primary endpoint will be infarct size as a percent of LV mass, measured at three to five days using cardiac MRI.
Secondary endpoints are a composite of the primary endpoint and any of the following:
- Cardiogenic shock after 24 hours post-enrollment to 30 days
- CV mortality at 24 months
- Heart failure requiring hospitalization at 24 months
- ICD and cardiac resynchronization therapy placement at 24 months
Five expert cardiologists and clinical trialists, including Kapur, will oversee the $25 million trial. STEMI DTU is sponsored by Abiomed and will employ the company’s Impella heart pumps, which haven’t yet been approved by the FDA for use in STEMI patients.
Find a detailed copy of the study’s protocol here.