Abbott has announced that the US Food and Drug Administration (FDA) has approved a change to its label for its HeartMate 3 left ventricular assist device (LVAD) allowing the removal of aspirin from its post-implantation medication regime.
The labelling update has also been approved by regulatory agencies in Canada and the European Union.
Blood thinners have historically been used by patients receiving LVADs as a means to reduce the risk of blood clots associated with the use of a blood pump implant. The ARIES-HM3 study was designed to ascertain whether aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients.
The 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 but did take 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.
“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,” said Mandeep R Mehra (Brigham and Women’s Hospital, Boston, USA) and the principal investigator of the ARIES-HM3 trial. “With this labelling 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.”
“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[1]enhancing benefits to people who rely on our devices to survive.”
