Document Detail


Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.
MedLine Citation:
PMID:  24210779     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Renal denervation (RDN) with radiofrequency ablation substantially reduces blood pressure in patients with treatment-resistant hypertension. We assessed the long-term antihypertensive effects and safety.
METHODS: Symplicity HTN-1 is an open-label study that enrolled 153 patients, of whom 111 consented to follow-up for 36 months. Eligible patients had a systolic blood pressure of at least 160 mm Hg and were taking at least three antihypertensive drugs, including a diuretic, at the optimum doses. Changes in office systolic blood pressure and safety were assessed every 6 months and reported every 12 months. This study is registered with ClinicalTrials.gov, numbers NCT00483808, NCT00664638, and NCT00753285.
FINDINGS: 88 patients had complete data at 36 months. At baseline the mean age was 57 (SD 11) years, 37 (42%) patients were women, 25 (28%) had type 2 diabetes mellitus, the mean estimated glomerular filtration rate was 85 (SD 19) mL/min per 1·73 m(2), and mean blood pressure was 175/98 (SD 16/14) mm Hg. At 36 months significant changes were seen in systolic (-32·0 mm Hg, 95% CI -35·7 to -28·2) and diastolic blood pressure (-14·4 mm Hg, -16·9 to -11·9). Drops of 10 mm Hg or more in systolic blood pressure were seen in 69% of patients at 1 month, 81% at 6 months, 85% at 12 months, 83% at 24 months, and 93% at 36 months. One new renal artery stenosis requiring stenting and three deaths unrelated to RDN occurred during follow-up.
INTERPRETATION: Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety.
FUNDING: Ardian LLC/Medtronic Inc.
Authors:
Henry Krum; Markus P Schlaich; Paul A Sobotka; Michael Böhm; Felix Mahfoud; Krishna Rocha-Singh; Richard Katholi; Murray D Esler
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2013-11-07
Journal Detail:
Title:  Lancet     Volume:  383     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2014 Feb 
Date Detail:
Created Date:  2014-02-17     Completed Date:  2014-03-10     Revised Date:  2014-08-26    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  622-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2014 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00483808;  NCT00664638;  NCT00753285
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MeSH Terms
Descriptor/Qualifier:
Antihypertensive Agents / therapeutic use
Blood Pressure / physiology
Catheter Ablation / methods*
Chronic Disease
Diabetic Angiopathies / physiopathology,  surgery
Drug Resistance
Female
Glomerular Filtration Rate / physiology
Humans
Hypertension / drug therapy,  physiopathology,  surgery*
Male
Middle Aged
Sympathectomy / methods*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antihypertensive Agents
Comments/Corrections
Comment In:
Dtsch Med Wochenschr. 2014 Mar;139(13):630   [PMID:  24648173 ]
Lancet. 2014 Feb 15;383(9917):583-4   [PMID:  24210778 ]
Nat Rev Nephrol. 2014 Jan;10(1):3   [PMID:  24275834 ]
Lancet. 2014 May 31;383(9932):1884   [PMID:  24881985 ]
MMW Fortschr Med. 2013 Dec 16;155(21-22):35   [PMID:  24724266 ]
Lancet. 2014 May 31;383(9932):1885   [PMID:  24881988 ]
Lancet. 2014 May 31;383(9932):1885   [PMID:  24881986 ]
Lancet. 2014 May 31;383(9932):1885-6   [PMID:  24881987 ]
Erratum In:
Lancet. 2014 Feb 15;383(9917):602
Note: Sobotka, Paul A [added]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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