title: An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and Non-African Americans in the SYMPLICITY HTN-3 trial.
abstract: SYMPLICITY HTN-3, the first trial of renal denervation (RDN) versus sham, enrolled 26% African Americans, a prospectively stratified cohort. Although the 6-month systolic blood pressure (SBP) reduction in African Americans (AAs) was similar in the RDN group (-15.5 ± 25.4 mm Hg, n = 85 vs. -17.8 ± 29.2, n = 49, P = .641), the sham SBP response was 9.2 mm Hg greater (P = .057) in AAs than non-AAs. In multivariate analyses, sham SBP response was predicted by an interaction between AA and a complex antihypertensive regimen (at least one antihypertensive medication prescribed ≥3 times daily), while in the RDN group, SBP response was predicted by an interaction between AA race and baseline BP ≥ 180 mm Hg. AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment arms that affect the observed pattern of SBP responses.
authors.affiliation: Department of Medicine, Division of General Medicine, Hypertension Section, Southern Illinois University, Springfield, IL, USA. Electronic address: jflack47@siumed.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Flack
authors.affiliation: Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: Department of Medicine, Division of Cardiology, Piedmont Heart Institute, Atlanta, GA, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Department of Medicine, Cardiovascular Division, The Heart Hospital Baylor Plano, Plano, TX, USA.
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.affiliation: Clinical Department, Medtronic CardioVascular, Santa Rosa, CA, USA.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Brar
authors.affiliation: Baylor Soltero Cardiovascular Research Center, Heart and Vascular Hospital, Dallas, TX, USA.
authors.forename: James W
authors.initials: JW
authors.lastname: Choi
authors.affiliation: Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.affiliation: Baylor Soltero Cardiovascular Research Center, Heart and Vascular Hospital, Dallas, TX, USA.
authors.forename: Cara
authors.initials: C
authors.lastname: East
authors.affiliation: Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.affiliation: Clinical Department, Medtronic CardioVascular, Santa Rosa, CA, USA.
authors.forename: Lilian
authors.initials: L
authors.lastname: Lee
authors.affiliation: Department of Medicine, Division of Cardiology, New York Presbyterian Hospital, Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, MA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: Department of Medicine, Division of Cardiology, Henry Ford Detroit Hospital, Detroit, MI, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.affiliation: Department of Medicine, Division of Cardiovascular Disease, University of Alabama, Birmingham, AL, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.affiliation: Chief Scientific Officer, Prairie Heart Institute at St John's Hospital, Springfield, IL, USA.
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.affiliation: Department of Medicine, Renal Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.affiliation: Hypertensive Disease Center, The University of Chicago Medicine, Chicago, IL, USA.
authors.forename: George
authors.initials: G
authors.lastname: Bakris
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation; D015331:Cohort Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000208:ethnology / Q000503:physiopathology* / Q000601:surgery*; D007668:Kidney / Q000294:innervation*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D013562:Sympathectomy / Q000379:methods; D013564:Sympathetic Nervous System / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents
keywords: African American; Renal denervation; uncontrolled apparent treatment-resistant hypertension