Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): A randomised controlled trial

Murray D. Esler, Henry Krum, Paul A. Sobotka, Markus P. Schlaich, Roland E. Schmieder, Michael Böhm, Felix Mahfoud, Horst Sievert, Nina Wunderlich, Lars Christian Rump, Oliver Vonend, Michael Uder, Mel Lobo, Mark Caulfield, Andrejs Erglis, Michel Azizi, Marc Sapoval, Suku Thambar, Alexandre Persu, Jean RenkinHeribert Schunkert, Joachim Weil, Uta C. Hoppe, Tony Walton, Dierk Scheinert, Thomas Binder, Andrzej Januszewicz, Adam Witkowski, Luis M. Ruilope, Robert Whitbourn, Heike Bruck, Mark Downes, Thomas F. Lüscher, Alan G. Jardine, Mark W. Webster, Thomas Zeller, Jerzy Sadowski, Krzysztof Bartus, Craig A. Straley, Neil C. Barman, David P. Lee, Ronald M. Witteles, Vivek Bhalla, Joseph M. Massaro

Research output: Contribution to journalArticle

1674 Citations (Scopus)

Abstract

Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. 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 effectiveness endpoint was change in seated office-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. 106 (56) 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 (94) of 52 patients who underwent renal denervation and 51 (94) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ 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 differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients. Ardian.

Original languageEnglish
Pages (from-to)1903-1909
Number of pages7
JournalThe Lancet
Volume376
Issue number9756
DOIs
Publication statusPublished - 4 Dec 2010
Externally publishedYes

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