Esler, Murray D., Krum, Henry, Sobotka, Paul A., Schlaich, Markus P., Schmieder, Roland E., Boehm, Michael, Mahfoud, Felix, Sievert, Horst, Wunderlich, Nina, Rump, Lars Christian, Vonend, Oliver, Uder, Michael, Lobo, Mel, Caulfield, Mark ORCID: 0000-0001-9295-3594, Erglis, Andrejs, Azizi, Michel, Sapoval, Marc, Thambar, Suku ORCID: 0000-0002-0801-7021, Persu, Alexandre ORCID: 0000-0002-4007-9695, Renkin, Jean, Schunkert, Heribert, Weil, Joachim, Hoppe, Uta C., Walton, Tony, Scheinert, Dierk, Binder, Thomas, Januszewicz, Andrzej, Witkowski, Adam, Ruilope, Luis M., Whitbourn, Robert, Bruck, Heike, Downes, Mark, Luescher, Thomas F., Jardine, Alan G., Webster, Mark W., Zeller, Thomas, Sadowski, Jerzy, Bartus, Krzysztof, Straley, Craig A., Barman, Neil C., Lee, David P., Witteles, Ronald M., Bhalla, Vivek ORCID: 0000-0002-5420-9657 and Massaro, Joseph M. (2010). Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet, 376 (9756). S. 1903 - 1910. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-547X

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Esler, Murray D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krum, HenryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sobotka, Paul A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlaich, Markus P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmieder, Roland E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boehm, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahfoud, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sievert, HorstUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wunderlich, NinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rump, Lars ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vonend, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uder, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lobo, MelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Caulfield, MarkUNSPECIFIEDorcid.org/0000-0001-9295-3594UNSPECIFIED
Erglis, AndrejsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Azizi, MichelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sapoval, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thambar, SukuUNSPECIFIEDorcid.org/0000-0002-0801-7021UNSPECIFIED
Persu, AlexandreUNSPECIFIEDorcid.org/0000-0002-4007-9695UNSPECIFIED
Renkin, JeanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schunkert, HeribertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weil, JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoppe, Uta C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Walton, TonyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheinert, DierkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Binder, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Januszewicz, AndrzejUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witkowski, AdamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruilope, Luis M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Whitbourn, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruck, HeikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Downes, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luescher, Thomas F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jardine, Alan G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Webster, Mark W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeller, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sadowski, JerzyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartus, KrzysztofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Straley, Craig A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barman, Neil C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lee, David P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witteles, Ronald M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bhalla, VivekUNSPECIFIEDorcid.org/0000-0002-5420-9657UNSPECIFIED
Massaro, Joseph M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-490804
DOI: 10.1016/S0140-6736(10)62039-9
Journal or Publication Title: Lancet
Volume: 376
Number: 9756
Page Range: S. 1903 - 1910
Date: 2010
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1474-547X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
NERVOUS-SYSTEM; BLOOD-PRESSURE; ACTIVATION; MECHANISMS; SPILLOVER; NERVESMultiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/49080

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