AGH Participates in Groundbreaking Clinical Trial Demonstrating Aspirin-Free Regimen Has Better Outcomes in Left Ventricular Assist Device Patients

Cardiologists Anticipate Results of International Clinical Trial Will Alter Standard Medication Therapy for Heart Failure Patients Living with LVAD Support

PITTSBURGH – A multi-institution research team that included Pittsburgh-based Allegheny General Hospital (AGH), the academic flagship of Allegheny Health Network (AHN), has published a groundbreaking clinical study demonstrating that avoidance of aspirin in patients with left ventricular devices (LVADs) results in better health outcomes and fewer adverse cardiovascular events.

Heart failure specialists within the AHN Cardiovascular Institute enrolled more than 20 patients of 628 who participated in the international ARIES-HM3 randomized, placebo-controlled clinical trial, which was published in The Journal of the American Medical Association in November (doi:10.1001/jama.2023.23204).

Use of aspirin, in addition to warfarin (blood thinner) is considered the standard of care following LVAD implant procedures. However, many patients develop bleeding complications following surgery, requiring blood transfusions and hospitalizations.

The Abbott-sponsored study determined that LVAD patients who didn’t take aspirin daily following their heart pump implant experienced fewer bleeding complications and had fewer hospital visits, compared to patients who did follow a daily aspiring regimen.

Ventricular assist devices are mechanical implants that aid in cardiac circulation, supporting the function of a failing heart. It can be used as a temporary recovery aid, a long-term standalone therapy, or as a bridge therapy that supports heart-failure patients awaiting heart transplantation. 

The implantation of the device is a significant procedure, typically requiring four to six hours of open-heart surgery. As with any significant surgery, LVAD implantation carries the risk of post-procedure adverse events.

The results of the trial have the potential to alter the standard course of treatment for patients living with heart pumps, according to Manreet Kanwar, MD, principal investigative lead of the trial at AGH and co-director of AHN's heart failure division.

“The primary goal of the clinical trial was to understand if the exclusion of aspirin for heart failure patients with an LVAD would be safe, effective and even prove beneficial,” Dr. Kanwar said. “Our findings demonstrated that there was a notable decrease in adverse events including major, nonsurgical bleeding within the placebo group.”

As part of the clinical trial, 456 men and 133 women with a HM3 LVAD (heart pump) in advanced-stage heart failure were enrolled; half were placed on an aspirin regimen while the remaining patients received a placebo. All participants were also given warfarin, referred to as a vitamin K antagonist (VKA), throughout the study.

LVADs can enhance the quality and duration of life in advanced heart failure by taking over the work of the heart’s left ventricle. The heart’s left ventricle pumps blood full of oxygen out to all tissues of the body and is considered the “workhorse” of the heart. The LVAD device at the center of the study was the HeartMate 3 by Abbott Laboratories, which is currently the only commercially available LVAD device in the United States.

Nonsurgical bleeding events are a leading cause of death in LVAD patients. Aspirin as an antiplatelet agent is a mandated component of treatment along with vitamin K antagonists for LVADs, despite a lack of conclusive evidence of aspirin efficacy and safety under this scenario.

Trial researchers estimated that for every 100 patients implanted with LVAD, aspirin avoidance prevented 14.5 major bleeding events in the first year, resulting in a 47% decrease in days spent in the hospital and a 41% reduction in the cost of care for bleeding events. These findings suggest that avoidance of aspirin provides meaningful improvement in clinical outcomes in patients with advanced heart failure. Overall, there was a 6% improvement in cardiac event-free survival within the placebo group.

“On behalf of the entire Cardiovascular Institute at Allegheny Health Network, I would like to congratulate our VAD team for their tireless commitment to improving the health of our patients. This was the first medical therapy assessed in a LVAD randomized clinical trial, and we’re confident it will alter the practice of medication management for LVAD patients moving forward,” concluded Dr. Kanwar.

In October 2023, AHN Cardiovascular Institute at AGH also announced it was the first hospital in western Pennsylvania to participate in an international clinical trial for a new, first-of-its-kind heart failure treatment device, AccuCinch. The device aims to reduce the size of the heart’s left ventricle, improving the heart’s strength and blood-pumping function therefore mitigating heart failure symptoms. 

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