title: Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan.
abstract: High nighttime and early morning blood pressure (BP) have been associated with greater risk for cardiovascular events than high clinic or daytime BP. BP is typically highest in the rising hours, when morning activities typically begin. We examined the effect of renal denervation on morning (6:00-8:59 AM), daytime (9:00 AM-8:59 PM), and nighttime (1:00-5:59 AM) ambulatory BP. Patient data from 2 prospective, randomized controlled trials of patients with treatment-resistant, uncontrolled hypertension, one conducted in a US population (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]) and the other in a Japanese population (SYMPLICITY HTN-Japan [HTN-Japan]), were analyzed. Patients in SYMPLICITY HTN-3 and HTN-Japan were prescribed a similar number of baseline antihypertensive medications (5.2±1.4 versus 4.9±1.6, P=0.28), but the classes prescribed and changes in prescription varied by study. Among patients treated with renal denervation, although the number of ablation treatments were similar in both studies (11.2±2.8 versus 11.5±1.9, P=0.55), patients in SYMPLICITY HTN-3 were less likely to receive at least 1 four-quadrant ablation treatment (25% versus 82%, P<0.001). In SYMPLICITY HTN-3, compared with controls (n=159), patients treated with renal denervation (n=325) experienced a significantly greater change in morning (-7.3±19.8 mm Hg, P<0.001) and nighttime (-6.1±18.2 versus -1.6±19.7 mm Hg, P=0.02) but not daytime systolic BP (-7.2±16.2 versus -6.4±18.6 mm Hg, P=0.67). This same trend was observed in the pooled analysis with HTN-Japan. Reduction of BP during these high-risk periods might provide cardiovascular protection in drug-resistant hypertensive patients, although this will need to be proved in future randomized trials.
  
  
  BACKGROUND
  URL: www.clinicaltrials.gov; Unique identifiers: NCT01418261 (SYMPLICITY HTN-3) and NCT01644604 (HTN-Japan).
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.). kkario@jichi.ac.jp.
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.).
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.).
authors.forename: Sandeep
authors.initials: S
authors.lastname: Brar
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.).
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.).
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.affiliation: From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.); Division of Cardiovascular Disease, Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA (D.L.B.); Department of Clinical Research, Medtronic, Santa Rosa, CA (S.B., S.A.C., M.F.); Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.).
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology*; D018660:Blood Pressure Monitoring, Ambulatory / Q000379:methods*; D057785:Catheters; D002940:Circadian Rhythm; D003714:Denervation / Q000379:methods; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology*; D007668:Kidney / Q000294:innervation*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
chemical_list: D000959:Antihypertensive Agents
keywords: SYMPLICITY; ambulatory blood pressure monitoring; blood pressure; denervation; hypertension