No Benefit of Renal Denervation for Refractory Hypertension

Renal artery denervation does not reduce blood pressure in patients with refractory hypertension, concludes a sham-controlled trial in the New England Journal of Medicine.

The randomized, single-blind SYMPLICITY HTN-3 trial included 535 patients with severe resistant hypertension despite maximally tolerated doses of three or more drugs including a diuretic. In a 2:1 ratio, patients were assigned to catheter-based renal denervation or a sham procedure. The effects on blood pressure at follow-up were assessed, along with safety outcomes.

At 6 months, the mean change in office systolic blood pressure (the primary efficacy outcome) was 14.13 mm Hg in the renal denervation group versus 11.74 mm Hg in the sham group. There was also no significant difference in 24-hour ambulatory systolic blood pressure response: 6.75 and 4.79, respectively.

Analysis of diastolic blood pressure showed similar patterns. The rates of a composite safety outcome of death, ESRD, and other serious complications were not significantly different.

Unblinded studies have suggested a benefit of renal denervation for severe hypertension that is resistant to medical therapy. However, this single-blind trial found no significant difference in systolic blood pressure at 6 months’ follow-up. The authors discuss possible reasons for the discrepant results compared with the results of previous renal-denervation studies. [Bhatt DL, et al: A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014; 370: 1393–1401].