Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial
Double-blind RCT (n=628) found placebo plus a vitamin K antagonist (VKA) antithrombotic regimen (i.e. avoidance of aspirin) was non-inferior to aspirin (100mg/day)-VKA regimen, with a 6.0% absolute improvement in event-free survival at 12 months with placebo (P<0.001).
Source:
JAMA Network Open
SPS commentary:
The authors note that patients receiving left ventricular assist device (LVAD) support are treated with an antithrombotic regimen that includes aspirin and vitamin K antagonist (VKA), based on observations that platelet activation and inflammation predispose to device-related thromboembolic complications. However, the role of aspirin in this setting is controversial and has not been adequately studied. To address the ongoing burden of bleeding with LVADs, it has been suggested that aspirin may be avoided when VKAs are used, particularly in the presence of a more haemocompatible, fully magnetically levitated LVAD. The current study was designed to test this theory in patients with advanced heart failure with the fully magnetically levitated HeartMate 3HM3 LVAD.
As discussed in a related editorial, the primary endpoint (composite of survival free of nonsurgical major hemocompatibility-related adverse events [stroke, pump thrombosis, major nonsurgical bleeding, and arterial peripheral thromboembolism] at 12 months), favoured the placebo group, and this was primarily driven by a lower risk of major non-surgical bleeding, with an estimated reduction of 14.5 bleeding events per 100 patient-years of follow-up. Thrombotic events such as stroke were uncommon, but also numerically favoured the placebo group.
The authors caution, however, that these data cannot be extrapolated to the population of patients on continued support with devices other than HeartMate 3, which have different risk of thromboembolic complications and therefore a different balance of risks and benefits. In addition, there remains uncertainty about the value of aspirin therapy for patients with other indications for aspirin therapy, such as prior coronary artery bypass grafting and percutaneous coronary intervention.
A meta-analysis of this and the NOAH-AFNET 6 RCT of edoxaban found oral anticoagulation reduced the risk of ischaemic stroke (RR 0.68, 95% CI 0.50-0.92) in patients with device-detected atrial fibrillation and increased major bleeding (1.62, 95% CI 1.05-2.50).