In the ARIES-HM3 trial, the decision to exclude aspirin from the antithrombotic therapy regimen after HeartMate 3 left ventricular assist device (LVAD) implantation was shown to be a safer approach compared to the usual combination approach. The trial involved comparing the effectiveness of placebo in combination with warfarin or other vitamin K antagonist therapy, to low-dose aspirin, for the primary composite endpoint of survival free of stroke, pump thrombosis, major nonsurgical bleeding, and arterial peripheral thromboembolism over a span of 24 months. The results showed that placebo was noninferior to low-dose aspirin, with a 6.0 percentage point advantage in favor of placebo. This advantage was primarily driven by a reduction in bleeding events, with a relative 34% reduction in nonsurgical bleeding events. Notably, no device thrombosis occurred in either group. These findings, reported by Mandeep R. Mehra, MD, MSc, and colleagues, have significant implications for the management of patients with advanced heart failure who have been implanted with LVADs.
The results of the ARIES-HM3 trial indicate that aspirin is not required to maintain positive outcomes with a fully magnetically levitated LVAD in patients with advanced heart failure. In fact, the exclusion of aspirin from the antithrombotic therapy was associated with a reduction in bleeding events, thus suggesting that it is a safe approach. This is particularly important considering that the trial was truly placebo-controlled and randomized, making it a rare example of a positive medical therapy trial in patients with mechanical circulatory support in Stage D heart failure. The trial data provide an immediate opportunity to improve outcomes for patients with contemporary LVADs by avoiding aspirin therapy altogether. This could lead to a significant reduction in hospitalization days as well, which would greatly enhance the quality of life for these patients. By reducing bleeding risk and improving outcomes, the utility of LVADs is expected to increase.
The ARIES-HM3 trial has several implications for the management of patients with LVADs. The recommendations for antithrombotic therapy in these patients have not been updated to reflect the lower risk of thromboembolic complications associated with contemporary magnetically levitated centrifugal designs. With the positive results from the trial, it is imperative to reconsider the existing guidelines and adopt the exclusion of aspirin as a new standard of care. This approach has the potential to immediately improve outcomes for patients implanted with contemporary LVADs without requiring additional complex or expensive therapies.
However, it is important to note that the trial focused specifically on patients with a HeartMate 3 LVAD. Therefore, caution must be exercised when extrapolating the results to other LVAD devices, as different devices may carry varying risks of thromboembolic complications. Each device should be evaluated based on its own risk-benefit profile.
Despite the promising results of the ARIES-HM3 trial, there are still unanswered questions regarding the management of aspirin therapy in specific patient populations. Patients with prior coronary artery bypass grafting and percutaneous coronary intervention, for example, may have traditional indications for aspirin therapy. Further research is needed to determine whether these patients should discontinue aspirin therapy post-LVAD implantation. Additionally, there is a need for more definitive answers regarding patients who have experienced thromboembolic complications from their LVAD. These areas require further study to establish the most appropriate treatment strategies.
The ARIES-HM3 trial demonstrates that excluding aspirin from the antithrombotic regimen after HeartMate 3 LVAD implantation is a safe and effective approach. The results highlight the potential to improve outcomes for patients with advanced heart failure by avoiding aspirin therapy altogether. These findings have significant implications for the management of patients with LVADs, and it is vital that healthcare professionals reconsider current guidelines to reflect the new standard of care. Further research is needed to address remaining questions and provide more definitive answers regarding specific patient populations. Overall, this trial represents a significant step forward in the field of mechanical circulatory support and highlights the importance of continuously reassessing treatment strategies to optimize patient outcomes.