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.\u00a0 Despite the rapid adoption of catheter-based renal artery denervation, data from large scale randomised controlled trials remains absent.\u00a0 A total of \u00a0535 patients with severe resistant hypertension were randomized in a 2:1 ratio to renal denervation or a sham procedure consisting of renal angiography alone.\u00a0 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.\u00a0 The change in mean 24-hour ambulatory systolic pressure at 6 months was used as a secondary end-point.\u00a0\u00a0 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\u00b123.93 mm Hg vs -11.74\u00b125.94 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\u00b115.11 mmHg vs. -4.79\u00b117.25 mmHg; difference of -1.96 mm Hg, 95% CI, -4.97 to 1.06; P=0.98).<\/p>\n
Conclusions<\/strong><\/p>\n In this large-scale, sham-controlled, blinded trial, renal denervation did not result in significant blood pressure reductions.\u00a0 These findings call into question the utility of renal-denervation as part of current clinical practice.<\/p>\n