Heart pump company Abiomed (NSDQ:ABMD) has begun a clinical trial to determine whether pumping blood from the left ventricle after a heart attack will reduce the amount of dead tissue.
The ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) randomized controlled trial will explore whether using the company’s Impella heart pump to unload the left ventricle for 30 minutes before opening blocked arteries will lead to a reduction in heart failure rates. The first patient in the multi-center trial was enrolled at Spectrum Health in Grand Rapids, Mich., by Dr. Kevin Wolschleger.
If the trial yields positive results, it could be a boost to Abiomed, whose stock tumbled 20% in November on news of research that showed potentially serious complications involving Impella heart pumps.
The STEMI DTU trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack 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 prior to reperfusion. The other half will receive immediate reperfusion, the current global standard of care. The primary endpoint is the amount of dead heart tissue (infarct size) as a percent of left ventricular mass, measured at three to five days using cardiac MRI.
A study published in JAMA Cardiology in October found that deaths from heart failure increased 38% 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, according to Danvers, Mass.-based Abiomed.
The STEMI DTU RCT is the fourth completed or ongoing randomized controlled trial of Impella.
In an observational study whose results were released last month, researchers at Washington University School of Medicine in St. Louis found an increased risk of death, bleeding, acute kidney injury and stroke among patients while they were still hospitalized after receiving Impella pumps versus balloon pumps. After statistically adjusting for certain variables, the observational study found a 24% higher risk of death and 34% increased risk of stroke among people receiving Impella pump treatment versus balloon pumps.
The researchers analyzed data from the Premier Healthcare Database involving 48,000 people at 432 U.S. hospitals who underwent a heart stent procedure and required a mechanical assist device to support their heart during the procedure. Among those studied, 10% (4,782 patients) received an Impella pump, while 90% (43,524 patients) received an intra-aortic balloon pump.
“These data are observational, so they can’t prove causation,” research team leader Dr. Amit P. Amin said at the time. “But they underscore the need for large, randomized clinical trials and prospective registries to better understand and guide the use of cardiac support devices.”
Researchers at University of California San Francisco School of Medicine examined National Cardiovascular Data Registry (NCDR) data on people with cardiogenic shock who received treatment from an Impella or an intra-aortic balloon pump (IABP). The abstract said: “In-hospital death and major bleeding rates were significantly greater among patients receiving Impella when compared to IABP.”
An Abiomed official criticized the quality of the research.