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Implantable device lowered systolic BP in patients with resistant hypertension
Bisognano J. J Am Coll Cardiol. 2011;58:765-773.
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A pivotal phase 3 trial has shown that patients implanted with a device for the treatment of resistant hypertension had reductions in systolic BP.
However, the device (Rheos System, CVRx) did not meet two of its endpoints, including procedural safety.
John D. Bisognano, MD, PhD, and colleagues from several US institutions conducted the double blind, randomized trial in 265 patients with resistant hypertension. Patients were randomly assigned 2:1 to either baroreflex activation therapy (BAT) for the first 6 months (n=181; group A) or BAT after the 6-month visit (n=84; group B). The five primary endpoints were acute systolic BP responder rate at 6 months, sustained responder rate at 12 months, as well as procedure, BAT and device safety.
According to results, sustained responder rate, BAT and device safety all improved (P<.001 for all three), but acute responder rate and device safety did not. A trend toward improvement in mean decrease in systolic BP, one of the study’s secondary endpoints, was also observed (P=.08).
Additional efficacy analysis revealed that 42% of group A patients and 24% of group B patients achieved systolic BP of no higher than 140 mm Hg at 6 months (P=.005), whereas at 12 months, rates of 50% were reported in both groups.
“Future clinical trials will address the limitations of this study and further define the therapeutic benefit of BAT,” the researchers wrote. “New technology for delivering BAT that involves a less invasive implant procedure has been developed by CVRx and is currently undergoing confirmatory study in Europe.”
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