Now, the ARIES-HM3 randomized clinical trial might have ended it.
“We can now safely say that not giving aspirin is not only safe from a thromboembolic risk profile but results in improved adverse event rate by a significant reduction in non-surgical bleeding which is a well-known complication related to LVAD therapy,” said Mirnela Byku, MD, PhD, MBA, lead author of the study and director of the University of North Carolina (UNC) Durable Mechanical Circulatory Device Program at the UNC School of Medicine. “Improving not only longevity but also reducing morbidity and improving quality of life is a big focus in the field of MCS [mechanical circulatory support].”
Until this study, there had been no consensus in the field about the use of aspirin in the LVAD population. The paper was published in the Journal of the American Medical Association.
The international clinical trial was a randomized, double-blind, placebo-controlled study that involved 628 patients across 51 centers in nine countries. The participants were divided into two groups: one receiving aspirin (100 mg/d) and the other receiving a placebo in addition to vitamin K antagonist (VKA) therapy.
The goal was to determine if the risks of major nonsurgical hemocompatibility–related adverse events (such as stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) within 12 months differed between the two groups.
The results indicated that withholding aspirin from patients with advanced heart failure, treated with a fully magnetic-levitated LVAD who are receiving VKAs, did not make their survival worse. In fact, the researchers found that aspirin avoidance was associated with a significant reduction (34%) in major nonsurgical bleeding events.
The decrease (34%) in major nonsurgical bleeding events was considered significant, while no notable increase in thromboembolic risk occurred. “The benefits of avoiding aspirin are consistent among those with prior vascular disease, including surgical or percutaneous coronary revascularization, obesity, or diabetes, which are characteristics associated with increased thrombosis risk,” the authors wrote.
The LVADs enhance the quality and duration of life in advanced heart failure, the authors pointed out, although nonsurgical bleeding events are a leading morbidity.
“Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety,” the researchers wrote, leading to their effects to determine the safety of excluding aspirin.
The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Of the 589 analyzed patients, 77% were men; one-third were black, and 61% were white.
The researchers determined that more patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) versus those taking aspirin (68%), adding that noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, –1.6%]; P <.001).
Background information in the article described how, with LVADs, mucosal surface bleeding, especially in the gastrointestinal system, can be a persistent issue and lead to hospitalization and healthcare resource use. The frequency has been increasing since the introduction of continuous-flow LVADs, the researchers noted.
“Patients receiving LVAD support are treated with an antithrombotic regimen that includes aspirin and vitamin K antagonist (VKA) therapy, mandated on observations that platelet activation and inflammation predispose to device-related thromboembolic complications,” the researchers added.
However, according to the study, “The role of aspirin as part of the antithrombotic regimen with VKA in patients using LVADs is controversial and has not been adequately studied, and observational studies have found disparate results among different LVAD types.”
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