Vagal Nerve Stimulation in Patients With Heart Failure and Reduced Ejection Fraction: The ANTHEM-HFrEF Trial - PubMed

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Vagal Nerve Stimulation (VNS) trial for heart failure with reduced ejection fraction was terminated early by the sponsor, not due to futility or efficacy.
Primary endpoint of time to cardiovascular death or HF hospitalization was not met (HR: 0.84, P=0.115).
Primary safety endpoint achieved 96.7% freedom from procedure- or device-related serious adverse events.
Autonomic engagement persisted long-term; trends favored outcomes, symptoms, and function but were inconclusive.
Left ventricular ejection fraction (LVEF) remained unchanged throughout the study.
Investigators adapted to early termination by prespecifying an exploratory win ratio, though results were hypothesis-generating.
Study provides guidance for investigators facing trial discontinuation while maintaining scientific integrity.

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