Medical device major Boston Scientific Corporation (BSX) recently revealed the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial at the 2014 European Society of Cardiology (:ESC) Congress in Barcelona, Spain. Following the failure of endpoint results, Boston Scientific's share price slipped 0.7% to eventually close at $12.59 yesterday.
Boston Scientific also plans to publish the study results in the European Heart Journal.
The NECTAR-HF trial is the first and only randomized clinical trial examining the efficacy of Boston Scientific's investigational vagal nerve stimulation (:VNS) device, involving sham-controlled research method. The key purpose of this study was to evaluate the effectiveness and safety of VNS in reducing cardiac remodeling and improving cardiac function in symptomatic heart failure patients.
Technically, the primary endpoint of the trial was reduction in left ventricular end systolic diameter at the end of six months as evaluated by a blinded echocardiography core laboratory. Secondary endpoints involved ejection fraction, left ventricular volumes, quality of life metrics, functional capacity, and changes in biomarkers.
The study examined 96 New York Heart Association (:NYHA) Class II-III patients, aged 18 years and above, suffering from left ventricular systolic dysfunction with an ejection fraction of less than 35%. All patients under trial continued to receive optimal medical therapy for heart failure.
These patients were randomized in 2:1 ratio to receive medical treatment plus an implanted active VNS device against medical treatment plus inactive VNS device, respectively, for the six-month trial period.
However, after the completion of the control period, inactive VNS devices were activated and all patients received the VNS therapy. A follow-up was conducted on all patients for 18 months with regularly reoccurring visits to achieve the safety endpoints.
Results of the Study
Unfortunately for Boston Scientific, the NECTAR-HF trial failed to significantly meet its six-month primary efficacy endpoint and majority of its secondary endpoint measures of cardiac remodeling and functional capacity in cardiac patients. However, the quality of life scores revealed a notable symptomatic improvement among the patients under trial.
Per management, administering VNS in cardiac patients failed to churn out any positive outcome. Going by the echocardiography derived measurements, the effect of therapy emerged no better than sham surgery.
Despite experiencing failure in the NECTAR-HF study, management is optimistic that such control group studies will play a crucial role in ramping up the efficiency of new VNS devices for heart failure therapy in the future.
Currently, Boston Scientific has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX) and Conatus Pharmaceuticals Inc. (CNAT). While ICU Medical sports a Zacks Rank #1 (Strong Buy), Abaxis and Conatus hold a Zacks Rank #2 (Buy).