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news.Boston Scientific has released the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial, the first and only randomized sham-controlled clinical trial investigating vagus nerve stimulation (VNS) to treat heart failure patients.
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The trial evaluated 96 New York Heart Association (NYHA) Class II-III patients with heart failure and an ejection fraction of less than 35%.
During the trial, all patients continued receiving optimal medical treatment for heart failure, but were randomized 2:1 to treatment or sham (implanted device but not receiving therapy), respectively.
The trial failed to meet the pre-specified six month primary efficacy endpoint of a reduction in left ventricular end systolic diameter as evaluated by a blinded echocardiography core laboratory.
Quality of life metrics showed significant symptomatic improvement despite the lack of a significant effect on primary and secondary endpoint measures of cardiac remodeling and functional capacity in HF patients.
Institut National de la Sante et de la Recherche Medicale professor of Therapeutics and Cardiology and director of the Clinical Investigation Center Faiez Zannad said the careful design and execution of NECTAR-HF has resulted in high quality data that will improve the understanding of the role of VNS in the treatment of patients with heart failure.
"Although patients receiving therapy reported feeling better as assessed by quality of life questionnaires, the application of VNS failed to reveal clear benefit when compared to sham, because the effect of therapy was no better than sham on echocardiography derived measurements," Zannad said.
"Inclusion of an appropriate control group is crucial, and a randomized study like NECTAR-HF should be the benchmark for future studies of novel device therapies for the treatment of heart failure."
After six months of randomization, control patients started to receive active therapy.
The company said that all patients are followed through 18 months for the safety endpoint.
Boston Scientific Rhythm Management chief medical officer Kenneth Stein said the company is happy to have collaborated with the investigators who have added significantly to the scientific knowledge of vagus nerve stimulation for the treatment of heart failure.
"We remain committed to advancing clinical science, exploring novel therapies, and providing new diagnostic options for patients with heart failure," Stein said .