Melvin D Lobo1, Paul A Sobotka2, Alice Stanton3, John R Cockcroft4, Neil Sulke5, Eamon Dolan6, Markus van der Giet7, Joachim Hoyer8, Stephen S Furniss9, John P Foran10, Adam Witkowski11, Andrzej Januszewicz12, Danny Schoors13, Konstantinos Tsioufis14, Benno J Rensing15, Benjamin Scott16, G André Ng17, Christian Ott18, Roland E Schmieder18. 1. 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. 2. ROX Medical, San Clemente, CA, USA; Cardiovascular Medicine, Ohio State University, Columbus, OH, USA. 3. Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland Medical School, Dublin, Ireland. 4. Cardiology Department, Wales Heart Research Institute, Cardiff, UK. 5. Cardiology Department, Eastbourne District General Hospital, East Sussex, UK. 6. Department of Medicine for the Elderly, Connolly Hospital, Dublin, Ireland. 7. Department of Endocinrology and Nephrology, Universitätsmedizin Berlin, Berlin, Germany. 8. Department of Internal Medicine and Nephrology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany. 9. Department of Cardiology, East Sussex Healthcare NHS Trust, East Sussex, UK. 10. Cardiac Department, Royal Brompton Hospital, London, UK; Cardiology Department, St Helier Hospital, Surrey, UK. 11. Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw, Poland. 12. Department of Hypertension, Institute of Cardiology, Warsaw, Poland. 13. Department of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium. 14. Department of Cardiology, Hippokration General Hospital of Athens, Athens, Greece. 15. Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein, Netherlands. 16. Department of Cardiology, ZNA-Cardio Middelheim, Antwerp, Belgium. 17. Department of Cardiovascular Sciences, University of Leicester Glenfield Hospital/NIHR Leicester Cardiovascular Biomedical Research, Leicester, UK. 18. Department of Nephrology and Hypertension, Universitätsklinikum Erlangen, Erlangen, Germany.
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 daytimeambulatory blood pressureof 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: ROX Medical.
RCT Entities:
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. FINDINGS: 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. INTERPRETATION: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. FUNDING: ROX Medical.
Authors: Stefan C Bertog; Nathan A Sobotka; Paul A Sobotka; Melvin D Lobo; Kolja Sievert; Laura Vaskelyte; Horst Sievert; Roland E Schmieder Journal: Curr Hypertens Rep Date: 2018-03-19 Impact factor: 5.369
Authors: Robert M Carey; David A Calhoun; George L Bakris; Robert D Brook; Stacie L Daugherty; Cheryl R Dennison-Himmelfarb; Brent M Egan; John M Flack; Samuel S Gidding; Eric Judd; Daniel T Lackland; Cheryl L Laffer; Christopher Newton-Cheh; Steven M Smith; Sandra J Taler; Stephen C Textor; Tanya N Turan; William B White Journal: Hypertension Date: 2018-11 Impact factor: 10.190