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Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.

Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.

Author information

  • 1Monash Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, Australia. Electronic address: henry.krum@monash.edu.
  • 2Neurovascular Hypertension and Kidney Disease Laboratory, Baker IDI Heart and Diabetes Institute and Heart Centre, Alfred Hospital, Melbourne, VIC, Australia.
  • 3Davis Heart and Lung Research Institute, Ohio State University, Columbus, OH, USA.
  • 4Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinium des Saarlandes, Homburg, Germany.
  • 5Prairie Heart Institute at St John's Hospital, Springfield, IL, USA.
  • 6Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.

Erratum in

  • Lancet. 2014 Feb 15;383(9917):602. Sobotka, Paul A [added].

Abstract

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.

Copyright © 2014 Elsevier Ltd. All rights reserved.

PMID:
24210779
[PubMed - indexed for MEDLINE]
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