The investigators "were performing a procedure, but they didn’t have the evidence that the procedure was accomplishing what it meant to accomplish," commented Dr. Anthony DeMaria, professor of medicine, the Judith and Jack White chair of cardiology, and director of the cardiovascular center at the University of California, San Diego, who was not involved in the trial. "Most of us feel there are tantalizing data to suggest that denervation can have a benefit, but they need to go back to the physiology to be sure they are denervating effectively."
Though Dr. Bakris and Dr. Esler cautioned that the study’s primary outcome was neutral, they see reason to hope that renal denervation will still prove to have an important and useful clinical effect.
"This report is the tip of the iceberg," Dr. Bakris noted. "When you look at the effect of denervation on blood pressure variability, heart rate variability, and total control over 24 hours using ambulatory blood pressure monitoring, you see a different picture," results that will be reported later this year, he said.
And Dr. Esler said that his experience using renal denervation on about 300 patients with treatment-resistant hypertension has convinced him that denervation can produce real benefits when done properly.
"I’m not changing my practice" using renal denervation on refractory patients, he said. "I accumulated a lot of patients with severe, resistant hypertension, patients whom I couldn’t control with seven or eight different drug classes. But when renal denervation came along, it was like chalk and cheese. Suddenly, I had a therapy that worked. My clinical experience in patients who didn’t budge with medications totally convinces me" that renal denervation works.
SYMPLICITY HTN-3 was sponsored by Medtronic, the company that markets the device tested in the study. Dr. Bhatt said that he has received research grants from Medtronic and five other companies. Dr. Esler said that he has received consulting fees, honoraria, and research grants from Medtronic. Dr. Bakris said that he has received personal fees from Medtronic and five other companies. Dr. DeMaria said that he has received research grants from Angioblast Systems, Cardiovascular Biotherapeutics, General Electric Medical, Gilead, and Lantheus.
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