A groundbreaking study recently published in JAMA indicates that aspirin may not be necessary as part of an antithrombotic regimen for patients with a fully magnetically levitated left ventricular assist device (LVAD). Ochsner Health surgical director for the Mechanical Assist Device Circulatory Support Program, Dr. Aditya Bansal, was a contributing author on the study known as the ARIES-HM3 trial.
The ARIES-HM3 trial, a randomized trial involving 628 patients with advanced heart failure, compared the outcomes of patients who received aspirin (100 mg/d) with those who received a placebo in addition to a vitamin K antagonist (VKA) therapy. The trial was conducted across 51 centers in 9 countries, with patients enrolled from July 2020 to September 2022.
Dr. Bansal said, "LVADs have transformed the treatment of advanced heart failure; however, nonsurgical bleeding events remain a significant concern. We have commonly used aspirin as an antiplatelet agent alongside VKAs with continuous-flow LVADs, even though there has been limited evidence of its efficacy and safety. This study has demonstrated that excluding aspirin from the treatment plan resulted in a significant decrease (34%) in major nonsurgical bleeding events without increasing the risk of thromboembolic complications."
The results of the study were remarkable. Patients who did not receive aspirin had a higher rate of survival free from major nonsurgical hemocompatibility-related adverse events at 12 months compared to those who took aspirin. Furthermore, avoiding aspirin was associated with a significant reduction in nonsurgical bleeding events, without an increase in stroke or other thromboembolic events.
This study challenges the conventional approach and provides compelling evidence that excluding aspirin from the antithrombotic regimen is not only safe but also beneficial in reducing bleeding events. Researchers conclude that in patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoiding aspirin as part of the antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin.
Dr. Bansal shared, "the results of the ARIES-HM3 trial have the potential to transform clinical practice and improve outcomes for patients with advanced heart failure. This is an exciting development as we continue to refine best practices for treating heart failure patients."
