Health professionals for a new century: Ttransforming education to strengthen health systems in an interdependent world

Abstract

Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess eff ectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (?150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary eff ectiveness endpoint was change in seated offi ce-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00888433. Findings 106 (56percent) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94percent) of 52 patients who underwent renal denervation and 51 (94percent) of 54 controls were assessed for the primary endpoint at 6 months. Offi ce-based blood pressure measurements in the renal denervation group reduced by 32-12 mm Hg (SD 23-11, baseline of 178-96 mm Hg, p0?0001), whereas they did not diff er from baseline in the control group (change of 1-0 mm Hg [21-10], baseline of 178-97 mm Hg, p=0?77 systolic and p=0?83 diastolic). Between-group diff erences in blood pressure at 6 months were 33-11 mm Hg (p0?0001). At 6 months, 41 (84percent) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35percent) of 51 controls (p0?0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not diff er between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatmentresistant hypertensive patients. Funding Ardian.