Abbott Trial Data Shows Aspirin-Free Regimen Helps HeartMate 3 Users

Abbott revealed late-breaking data from its ARIES trial at this year’s American Heart Association’s Scientific Sessions.
 
Trial data showed that advanced heart failure patients living with its HeartMate 3 LVAD who didn’t receive aspirin as part of their blood-thinning medication regimen had fewer bleeding complications and were associated with fewer hospital visits, compared to patients who took aspirin with the implant.
 
The over-600-patient ARIES trial found HeartMate 3 patients who didn’t receive aspirin but continued using the standard post-implant vitamin-K antagonist (VKA) treatment regimen met the primary endpoint by showing non-inferiority of no aspirin to aspirin. HeartMate 3 patients who didn’t take aspirin spent 47% fewer days in the hospital due to an almost 40% decrease in bleeding events.
 
One year after receiving the device, Abbott said there was a 41% reduction in estimated costs related to bleeding events. The data also found this same group had no elevated risk in developing thrombosis.
 
“There is a general consensus within the medical community that aspirin use should be a mandatory part of the treatment regimen for heart failure patients living with an LVAD; however, those assumptions were largely driven by observational data that have rarely been challenged,” Robert Kormos, MD, divisional VP, global medical affairs for Abbott’s heart failure business, told the press. “The ARIES trial estimates that for every 100 people with the HeartMate 3, not taking aspirin prevents nearly 15 major bleeding events within their first year with the device. That equates to many more moments these patients can spend with their loved ones living a fuller life.”
 
“Abbott has focused its investments on ways that we can continue to improve the outcomes for the thousands of patients a year who are eligible to receive a heart pump,” added Keith Boettiger, VP of Abbott’s heart failure business. “With the ARIES trial, we’ve identified an important new approach to patient management that doctors can consider to reduce bleeding risk for their patients and make LVAD therapy more accessible to patients who need this life-saving device.”