title: Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial.
abstract: BACKGROUND
  Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension.
  
  
  METHODS
  We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498.
  
  
  RESULTS
  83 (43%) of 195 patients screened were assigned arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the arteriovenous coupler group (p<0·0001) and by 3·7 (21·2) mm Hg in the control group (p=0·31). Mean systolic 24 h ambulatory blood pressure reduced by 13·5 (18·8) mm Hg (p<0·0001) in arteriovenous coupler recipients and by 0·5 (15·8) mm Hg (p=0·86) in controls. Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting.
  
  
  CONCLUSIONS
  Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension.
  
  
  BACKGROUND
  ROX Medical.
authors.affiliation: William Harvey Research Institute, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University of London, London, UK. Electronic address: m.d.lobo@qmul.ac.uk.
authors.forename: Melvin D
authors.initials: MD
authors.lastname: Lobo
authors.affiliation: ROX Medical, San Clemente, CA, USA; Cardiovascular Medicine, Ohio State University, Columbus, OH, USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sobotka
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: Cardiology Department, Wales Heart Research Institute, Cardiff, UK.
authors.forename: John R
authors.initials: JR
authors.lastname: Cockcroft
authors.affiliation: Cardiology Department, Eastbourne District General Hospital, East Sussex, UK.
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 Endocinrology 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, UK.
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Furniss
authors.affiliation: Cardiac Department, Royal Brompton Hospital, London, UK; Cardiology Department, St Helier Hospital, Surrey, UK.
authors.forename: John P
authors.initials: JP
authors.lastname: Foran
authors.affiliation: Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Witkowski
authors.affiliation: Department of Hypertension, 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, Athens, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Tsioufis
authors.affiliation: Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein, Netherlands.
authors.forename: Benno J
authors.initials: BJ
authors.lastname: Rensing
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, UK.
authors.forename: G André
authors.initials: GA
authors.lastname: Ng
authors.affiliation: Department of Nephrology and Hypertension, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ott
authors.affiliation: Department of Nephrology and Hypertension, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D001166:Arteriovenous Shunt, Surgical / Q000379:methods*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D007083:Iliac Artery / Q000601:surgery*; D007084:Iliac Vein / Q000601:surgery*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult