Study: Renal Denervation Doesn’t Lower Blood Pressure
About 10,000 procedures have been performed worldwide
Renal denervation — an experimental therapy that was once hailed as a possible cure for patients whose hypertension does not respond to medication — has been shown to be ineffective, according to a new study published in the New England Journal of Medicine.
The treatment has been approved for use in 80 countries but is still considered experimental in the U.S. An estimated 10,000 procedures have been performed worldwide.
In a prospective, single-blind, randomized, sham-controlled trial, 535 patients with severe, resistant hypertension were randomly assigned to undergo renal denervation or a sham procedure. Before randomization, the patients were treated with a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic.
The study’s primary efficacy endpoint was the change in office systolic blood pressure (SBP) at 6 months. A secondary efficacy endpoint was the change in mean 24-hour ambulatory SBP. The primary safety endpoint was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months.
At 6 months, the mean change in SBP was –14.13 mm Hg in the denervation group compared with –11.74 mm Hg in the sham-procedure group (P < 0.001 for both comparisons of the change from baseline), for a difference of –2.39 mm Hg (P = 0.26 for superiority). The change in 24-hour ambulatory SBP was –6.75 mm Hg in the denervation group and –4.79 mm Hg in the sham-procedure group, for a difference of –1.96 mm Hg (P = 0.98 for superiority).
There were no significant differences in safety between the two groups.
The authors concluded that their study did not show a significant reduction of SBP in patients with resistant hypertension 6 months after renal-artery denervation compared with a sham control.