The prospect of percutaneous renal-artery denervation to treat hypertension has been widely heralded in response to pilot studies that demonstrated marked reductions in blood pressure after renal denervation. Despite the rapid adoption of catheter-based renal artery denervation, data from large scale randomised controlled trials remains absent. A total of 535 patients with severe resistant hypertension were randomized in a 2:1 ratio to renal denervation or a sham procedure consisting of renal angiography alone. All study patients were receiving a minimum of three antihypertensive medications, including a diuretic, with persistently elevated systolic blood pressures of 160mmHg or more. The primary end point was the change in office systolic blood pressure at 6 months. The change in mean 24-hour ambulatory systolic pressure at 6 months was used as a secondary end-point. Compared with the sham procedure, renal-artery denervation resulted in no significant reductions in blood pressure as determined by office measurement of systolic pressure (-14.13±23.93 mm Hg vs -11.74±25.94 mm Hg; difference of -2.39 mm Hg, 95% confidence interval [CI] -6.89 to 2.12; P=0.26) or mean 24-ambulatory pressure (-6.75±15.11 mmHg vs. -4.79±17.25 mmHg; difference of -1.96 mm Hg, 95% CI, -4.97 to 1.06; P=0.98).
In this large-scale, sham-controlled, blinded trial, renal denervation did not result in significant blood pressure reductions. These findings call into question the utility of renal-denervation as part of current clinical practice.
- Bhatt DL, Kandzari DE, O’Neill WW, D’Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. . A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401.
Summarized by Steven M. Bradley and Hussain Contractor