A Controlled Trial of Renal Denervation for Resistant Hypertension
What is the benefit of renal denervation in resistant hypertension?
SYMPLICITY HTN-3 was a single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. All patients were on a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic, prior to randomization. The primary efficacy endpoint was the change in office systolic blood pressure at 6 months, and a secondary efficacy endpoint was the change in mean 24-hour ambulatory systolic blood pressure. 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 >70% at 6 months.
A total of 535 patients underwent randomization. Similar improvement in blood pressure was seen in both arms with the mean (± standard deviation) change in systolic blood pressure at 6 months being -14.13 ± 23.93 mm Hg in the denervation group as compared with -11.74 ± 25.94 mm Hg in the sham-procedure group, for a difference of -2.39 mm Hg (95% confidence interval, -6.89 to 2.12; p = 0.26). There was a similar reduction in 24-hour ambulatory systolic blood pressure (-6.75 ± 15.11 mm Hg in the denervation group and -4.79 ± 17.25 mm Hg in the sham-procedure group, a difference of -1.96 mm Hg; p = 0.98).
The authors concluded that renal denervation did not result in a significant reduction of systolic blood pressure in patients with resistant hypertension as compared with a sham control.
Renal denervation was one of the most intriguing procedures to emerge over the last few years, and this carefully conducted trial failed to establish its efficacy. The results of this trial reaffirm the need for sham controlled trials in evaluation of invasive therapies.
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