CVRx has announced the preliminary topline results of the BeAT-HF—Baroreflex activation therapy for heart failure—postmarket randomised clinical trial.
The BeAT-HF postmarket phase of the multicentre, prospective, randomised controlled trial assessed 323 patients suffering from heart failure with reduced ejection fraction. The patients were randomised to two groups, treatment with Barostim, an extravascular implantable neuromodulation device, and guideline-directed medical therapy versus guideline-directed medical therapy alone.
The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity (specifically, worsening heart failure events requiring treatment in the hospital or emergency department). The trial accrued 332 primary events and had a median follow-up of 3.7 years, corresponding to 1,037 patient-years.
While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favoured Barostim, including:
- all-cause survival, free from left-ventricular assist device (LVAD) and heart transplant,
- a hierarchical composite (“Win Ratio”) analysis of cardiovascular mortality, heart failure events and quality of life, and
- a clinical stability analysis.
In addition, the safety profile of Barostim and the symptomatic improvement at six months, that were the basis for the US Food and Drug Administration (FDA) premarket approval, were shown to be durable through 24 months (where data collection was prespecified).
“On behalf of the Executive Steering Committee of BeAT-HF, I congratulate CVRx for conducting a rigorous scientific randomised controlled study that spanned seven years, to assess the benefits and risks of Barostim in patients with chronic heart failure with reduced ejection fraction,” said Michael R Zile (Medical University of South Carolina, Charleston, USA). “The new results from the postmarket phase of BeAT-HF confirm Barostim’s long-term symptomatic benefits and safety, and its use as an effective treatment for heart failure.”