Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial

Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, Van Der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder R (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Book Volume: 385

Pages Range: 1634-41

Journal Issue: 9978

DOI: 10.1016/S0140-6736(14)62053-5

Abstract

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.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 NCT01642498.83 (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.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.ROX Medical.

Authors with CRIS profile

Involved external institutions

Charité - Universitätsmedizin Berlin Germany (DE) University of Leicester United Kingdom (GB) ZNA Middelheim Belgium (BE) St. Antonius Ziekenhuis Netherlands (NL) General Hospital of Athens Hippocrates / Γενικό Νοσοκομείο Αθηνών «Ιπποκράτειο» Greece (GR) Cliniques universitaires Saint-Luc (CHU St-Luc) Belgium (BE) The Cardinal Stefan Wyszyński Institute of Cardiology / Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego Poland (PL) Royal Brompton Hospital United Kingdom (GB) East Sussex Healthcare NHS Trust United Kingdom (GB) Universitätsklinikum Gießen und Marburg (UKGM) Germany (DE) Connolly Hospital Blanchardstown / Ospidéal Uí Chonghaile, Baile Bhlainséir Ireland (IE) Eastbourne District General Hospital United Kingdom (GB) Cardiff University United Kingdom (GB) Royal College of Surgeons in Ireland (RCSI) Ireland (IE) ROX Medical United States (USA) (US) Queen Mary, University of London United Kingdom (GB)

How to cite

APA:

Lobo, M.D., Sobotka, P.A., Stanton, A., Cockcroft, J.R., Sulke, N., Dolan, E.,... Schmieder, R. (2015). Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet, 385(9978), 1634-41. https://doi.org/10.1016/S0140-6736(14)62053-5

MLA:

Lobo, Melvin D., et al. "Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial." Lancet 385.9978 (2015): 1634-41.

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