(MedPageToday.com) — Although a baroreflex activation therapy device designed to treat resistant hypertension lowered blood pressure, it failed to meet two of five coprimary endpoints in a pivotal trial, researchers found.
The trial did not meet endpoints regarding short-term systolic blood pressure response and safety of the procedure to implant the device, according to John Bisognano, MD, PhD, of the University of Rochester in New York, and colleagues.
It did, however, show a benefit on sustained response, safety of baroreflex activation therapy, and safety of the device, the researchers reported online in the Journal of the American College of Cardiology.
The findings were originally reported at the American College of Cardiology meeting in April.
The authors noted that all five of the coprimary endpoints needed to be met to establish the overall efficacy and safety of the Rheos device.
However, they wrote, “the weight of the overall evidence suggests that over the long-term, baroreflex activation therapy can safely reduce systolic blood pressure in patients with resistant hypertension. Future clinical trials will address the limitations of this study and further define the therapeutic benefit of [the therapy].”
They added that “new technology for delivering baroreflex activation therapy that involves a less invasive implant procedure has been developed by [Rheos manufacturer] CVRx and is currently undergoing confirmatory study in Europe.”
The Rheos system is targeted to the 20% to 30% of patients with hypertension who are resistant to treatment, defined as a failure to achieve a blood pressure less than 140/90 mm Hg with maximally tolerated doses of at least three antihypertensives, including a diuretic.
The system involves leads strung from a pulse generator implanted in a patient’s chest to each carotid sinus. The electrical impulses stimulate the baroreceptors there, reducing sympathetic activity and increasing parasympathetic activity, which causes the blood vessels to open and heart rate and blood pressure to drop.
In the current phase III trial, 265 patients with resistant hypertension — who were taking an average of 5.2 antihypertensives at baseline — were implanted with the device, which was turned off.
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