Abbott Removes Aspirin Regimen for Patients Receiving HeartMate 3

Abbott announced that the U.S. Food and Drug Administration has approved a change to its label that will help patients who receive a HeartMate 3 left ventricular assist device (LVAD, or heart pump) by eliminating aspirin as part of routine patient management. The labeling update is exclusively for patients with an Abbott HeartMate 3 heart pump and has also been approved by regulatory agencies in Canada and the European Union.
 
“Aspirin, along with warfarin, has traditionally been mandated for advanced heart failure patients living with an LVAD, but whether it contributes to excessive bleeding has been uncertain. The ARIES-HM3 trial, in which aspirin was removed from the medication regimen, provided important data challenging the assumption that patients with a heart pump must take aspirin daily. With this labeling change, physicians can avoid using aspirin in patients receiving the HeartMate 3 LVAD, a decision that is safe, and decreases bleeding and its associated hospital visits,” said Mandeep R. Mehra, M.D., executive director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, MA and the principal investigator of the ARIES-HM3 trial.
 
The ARIES-HM3 trial was an international, randomized study of either aspirin (100mg/day) or placebo with vitamin K antagonist (VKA) therapy in advanced heart failure patients newly implanted with Abbott’s HeartMate 3 LVAD (ages 18 and older). 
 
The ARIES-HM3 study was designed to help clinicians understand if aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients. The ARIES-HM3 trial showed that patients who received an Abbott HeartMate 3 heart pump but didn’t take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot compared to patients who also received a HeartMate 3 and took aspirin. 
 
As a result of reduced bleeding risk, the ARIES-HM3 trial also found patients avoiding aspirin post-implant experienced reduced days in the hospital compared to patients who took aspirin daily.
 
The HeartMate 3 patients who did not take aspirin spent 47% fewer days in the hospital due to a nearly 40% decrease in bleeding events compared to patients who continued to take aspirin daily. The data also found this same group had no elevated risk of developing thrombosis (a blood clot that increases the risk of stroke).
 
Abbott’s HeartMate 3 heart pump is an implantable device that pumps blood through the body in people whose hearts are too weak to do so on its own. It is the only commercially approved heart pump with Full MagLev technology, allowing the device’s rotor to be “suspended” by magnetic forces. 
 
This unique design has been proven to reduce trauma to blood passing through the pump, improving patient survival and quality of life. These factors have led to HeartMate 3 offering the lowest rate of pump-related complications of any other blood pump.
 
“Removing aspirin from the medication regimen for the HeartMate 3 is a simple change that means people with an Abbott LVAD can focus on the things they love and spend less time worrying about and tending to bleeding events,” said Keith Boettiger, vice president, Abbott’s heart failure business. “Through research such as the ARIES-HM3 trial, we continue to rewrite the book on the management of patients with advanced heart failure and focus on bringing life-enhancing benefits to people who rely on our devices to survive.”