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

被引：1741

作者：

Esler, Murray D. ^{[28
]}

Krum, Henry ^{[1
]}

Sobotka, Paul A. ^{[2
]}

Schlaich, Markus P. ^{[28
]}

Schmieder, Roland E. ^{[3
]}

Boehm, Michael ^{[4
]}

Mahfoud, Felix ^{[4
]}

Sievert, Horst ^{[5
]}

Wunderlich, Nina ^{[5
]}

Rump, Lars Christian ^{[6
]}

Vonend, Oliver ^{[6
]}

Uder, Michael ^{[3
]}

Lobo, Mel ^{[7
]}

Caulfield, Mark ^{[7
]}

Erglis, Andrejs ^{[8
]}

Azizi, Michel ^{[9
]}

Sapoval, Marc ^{[9
]}

Thambar, Suku ^{[10
]}

Persu, Alexandre ^{[11
]}

Renkin, Jean ^{[11
]}

Schunkert, Heribert ^{[12
]}

Weil, Joachim ^{[12
]}

Hoppe, Uta C. ^{[13
]}

Walton, Tony ^{[1
]}

Scheinert, Dierk ^{[14
]}

Binder, Thomas ^{[15
]}

Januszewicz, Andrzej ^{[16
]}

Witkowski, Adam ^{[16
]}

Ruilope, Luis M. ^{[17
]}

Whitbourn, Robert ^{[18
]}

Bruck, Heike ^{[19
]}

Downes, Mark ^{[20
]}

Luescher, Thomas F. ^{[21
]}

Jardine, Alan G. ^{[22
]}

Webster, Mark W. ^{[23
]}

Zeller, Thomas ^{[24
]}

Sadowski, Jerzy ^{[25
]}

Bartus, Krzysztof ^{[25
]}

Straley, Craig A. ^{[2
]}

Barman, Neil C. ^{[2
]}

Lee, David P. ^{[26
]}

Witteles, Ronald M. ^{[26
]}

Bhalla, Vivek ^{[26
]}

Massaro, Joseph M. ^{[27
]}

机构：

[1] Alfred Hosp, Melbourne, Vic, Australia

[2] Ardian, Mountain View, CA USA

[3] Univ Erlangen Nurnberg, Erlangen, Germany

[4] Univ Klinikum Saarlandes, Homburg, Germany

[5] CardioVasc Ctr Frankfurt, Frankfurt, Germany

[6] Univ Klinikum Dusseldorf, Dusseldorf, Germany

[7] Queen Mary Univ London, Barts & London NIHR Cardiovasc Biomed Res Unit, William Harvey Res Inst, London, England

[8] Paula Stradins Clin Univ Hosp, Riga, Latvia

[9] Hop Europeen Georges Pompidou, AP HP, Paris, France

[10] John Hunter Hosp, Newcastle, NSW, Australia

[11] Clin Univ St Luc, B-1200 Brussels, Belgium

[12] Univ Klinikum Schleswig Holstein, D-23538 Lubeck, Germany

[13] Univ Cologne, Cologne, Germany

[14] Univ Leipzig, Herzzentrum, Leipzig, Germany

[15] Allgemeines Krankenhaus Stadt Wien, Vienna, Austria

[16] Samodzielna Pracownia Hemodynamiczna, Warsaw, Poland

[17] Hosp 12 Octubre, E-28041 Madrid, Spain

[18] St Vincents Hosp, Melbourne, Vic, Australia

[19] Univ Klinikum Essen, Essen, Germany

[20] Kent & Canterbury Hosp, Canterbury, Kent, England

[21] Univ Zurich Hosp, CH-8091 Zurich, Switzerland

[22] Univ Glasgow, Glasgow, Lanark, Scotland

[23] Auckland City Hosp, Auckland, New Zealand

[24] Herz Zentrum Bad Krozingen, Bad Krozingen, Germany

[25] Jagiellonian Univ, John Paul II Hosp, Krakow, Poland

[26] Stanford Univ, Stanford, CA 94305 USA

[27] Harvard Clin Res Inst, Boston, MA USA

[28] Baker IDI Heart & Diabet Inst, Melbourne, Vic, Australia

来源：

LANCET | 2010年 / 376卷 / 9756期

基金：

英国医学研究理事会;

关键词：

NERVOUS-SYSTEM; BLOOD-PRESSURE; ACTIVATION; MECHANISMS; SPILLOVER; NERVES;

D O I：

10.1016/S0140-6736(10)62039-9

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background 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. 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 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. Findings 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. Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients.

引用

页码：1903 / 1909

页数：7

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