title: Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety.
  
  
  BACKGROUND
  Ardian LLC/Medtronic Inc.
authors.affiliation: Monash 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.
authors.forename: Henry
authors.initials: H
authors.lastname: Krum
authors.affiliation: Neurovascular Hypertension and Kidney Disease Laboratory, Baker IDI Heart and Diabetes Institute and Heart Centre, Alfred Hospital, Melbourne, VIC, Australia.
authors.forename: Markus P
authors.initials: MP
authors.lastname: Schlaich
authors.affiliation: Davis Heart and Lung Research Institute, Ohio State University, Columbus, OH, USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sobotka
authors.affiliation: Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinium des Saarlandes, Homburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinium des Saarlandes, Homburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Mahfoud
authors.affiliation: Prairie Heart Institute at St John's Hospital, Springfield, IL, USA.
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.affiliation: Prairie Heart Institute at St John's Hospital, Springfield, IL, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Katholi
authors.affiliation: Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.
authors.forename: Murray D
authors.initials: MD
authors.lastname: Esler
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000502:physiology; D017115:Catheter Ablation / Q000379:methods*; D002908:Chronic Disease; D003925:Diabetic Angiopathies / Q000503:physiopathology / Q000601:surgery; D004351:Drug Resistance; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D013562:Sympathectomy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents