title: 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial.
abstract: BACKGROUND
  Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure.
  
  
  OBJECTIVE
  This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group).
  
  
  METHODS
  Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed.
  
  
  RESULTS
  The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg.
  
  
  CONCLUSIONS
  These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
authors.affiliation: ASH Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois. Electronic address: gbakris@medicine.bsd.uchicago.edu.
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.affiliation: Renal Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.affiliation: Division of Translational Research and Clinical Epidemiology, Wayne State University and the Detroit Medical Center, Detroit, Michigan.
authors.forename: John M
authors.initials: JM
authors.lastname: Flack
authors.affiliation: Coronary and Structural Heart Disease Management, Medtronic, Inc., Santa Rosa, California.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Brar
authors.affiliation: Renal Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Coronary and Structural Heart Disease Management, Medtronic, Inc., Santa Rosa, California.
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.affiliation: Mathematics and Statistics Department, Harvard Clinical Research Institute and Boston University School of Public Health, Boston, Massachusetts.
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.affiliation: Interventional Cardiology, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Baptist Cardiac and Vascular Institute, Miami, Florida.
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.affiliation: Center for Interventional Vascular Therapy, New York Presbyterian Hospital, Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Harvard Clinical Research Institute, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: Coronary and Structural Heart Disease Management, Medtronic, Inc., Santa Rosa, California.
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.affiliation: The Center for Structural Heart Disease, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.affiliation: Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.affiliation: Interventional Cardiology and Vascular Medicine, Prairie Heart Institute, Springfield, Illinois.
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.affiliation: Division of Cardiovascular Disease, Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology*; D001795:Blood Pressure Determination; D018660:Blood Pressure Monitoring, Ambulatory; D002404:Catheterization / Q000379:methods*; D018592:Cross-Over Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation*; D013562:Sympathectomy / Q000379:methods*; D016896:Treatment Outcome
keywords: ambulatory blood pressure monitoring; renal denervation; resistant hypertension