title: Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.
abstract: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an arteriovenous anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH.
  
  
  
  The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932).
  
  
  
  Our data suggest that creation of an arteriovenous anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension.
  
  
  
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.
authors.affiliation: Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ott
authors.affiliation: William Harvey Research Institute, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University of London, United Kingdom.
authors.forename: Melvin D
authors.initials: MD
authors.lastname: Lobo
authors.affiliation: ROX Medical, San Clemente, CA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sobotka
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Mahfoud
authors.affiliation: Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland Medical School, Dublin, Ireland.
authors.forename: Alice
authors.initials: A
authors.lastname: Stanton
authors.affiliation: Cardiolgy Department, Wales Heart Research Institute, Cardiff, United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Cockcroft
authors.affiliation: Cardiology Department, Eastbourne District General Hospital, East Sussex, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Sulke
authors.affiliation: Department of Medicine for the Elderly, Connolly Hospital, Dublin, Ireland.
authors.forename: Eamon
authors.initials: E
authors.lastname: Dolan
authors.affiliation: Department of Endocrinology and Nephrology, Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: van der Giet
authors.affiliation: Department of Internal Medicine and Nephrology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Hoyer
authors.affiliation: Department of Cardiology, East Sussex Healthcare NHS Trust, East Sussex, United Kingdom.
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Furniss
authors.affiliation: Cardiac Department, Royal Brompton Hospital, London, United Kingdom.|Cardiolgy Department, St. Helier Hospital, Surrey, United Kingdom.
authors.forename: John P
authors.initials: JP
authors.lastname: Foran
authors.affiliation: Institute of Cardiology, Warsaw, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Witkowski
authors.affiliation: Institute of Cardiology, Warsaw, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Januszewicz
authors.affiliation: Department of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Danny
authors.initials: D
authors.lastname: Schoors
authors.affiliation: Department of Cardiology, Hippokration General Hospital of Athens, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Tsioufis
authors.affiliation: Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
authors.forename: Benno J
authors.initials: BJ
authors.lastname: Rensing
authors.affiliation: William Harvey Research Institute, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University of London, United Kingdom.
authors.forename: Manish
authors.initials: M
authors.lastname: Saxena
authors.affiliation: Department of Cardiology, ZNA - Cardio Middelheim, Antwerp, Belgium.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Scott
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester Glenfield Hospital/NIHR Leicester Cardiovascular Biomedical Research, Leicester, United Kingdom.
authors.forename: G André
authors.initials: GA
authors.lastname: Ng
authors.affiliation: Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Achenbach
authors.affiliation: Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany roland.schmieder@uk-erlangen.de.
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
mesh_terms: D001166:Arteriovenous Shunt, Surgical / Q000379:methods*; D001794:Blood Pressure / Q000502:physiology*; D018660:Blood Pressure Monitoring, Ambulatory; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000601:surgery*; D007083:Iliac Artery / Q000601:surgery*; D007084:Iliac Vein / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: arteriovenous anastomosis; combined hypertension; isolated systolic hypertension; treatment resistant hypertension