The three-year study findings were presented at the American College of Cardiology 2022 Scientific Session and simultaneously published in The Lancet. The study used the Symplicity Spyral renal denervation system from Medtronic, which funded the study.
The randomized study enrolled 80 adults with uncontrolled hypertension not responding to up to three antihypertensive medications; 38 underwent renal denervation and 42 underwent a sham procedure.
"Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs," Dr. Felix Mahfoud of Saarland University, in Homburg, Germany, and colleagues report in their paper.
After 36 months, ambulatory systolic BP had dropped by 18.7 mm Hg in the renal-denervation group and by 8.6 mm Hg in the control group (adjusted treatment difference, 10.0 mm Hg; P=0.0039).
Following renal denervation, there was a "progressive" reduction in ambulatory blood pressure throughout follow-up and there were no safety issues associated with the procedure, the researchers report.
Renal denervation also led to significant reductions in night-time and early-morning ambulatory blood pressure at 24 months and 36 months, which "could translate into reductions in cardiovascular events, including stroke and heart failure," the team says.
"Renal denervation provides an adjunctive treatment modality besides lifestyle modifications and antihypertensive medications in the management of patients with uncontrolled hypertension," they conclude.
The study was funded by Medtronic. Several authors have disclosed financial relationships with Medtronic.
SOURCE: https://bit.ly/3vihD2C The Lancet, online April 4, 2022.
By Reuters Staff
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