Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial

Lobo MD, Ott C, Sobotka PA, Saxena M, 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, Schmieder R (2017)

Publication Type: Journal article

Publication year: 2017

Journal

DOI: 10.1161/HYPERTENSIONAHA.117.10142

Abstract

Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP >=140 mm Hg and average daytime ambulatory BP >=135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone. At 12 months, 39 patients who had coupler therapy were included in the intention-to-treat analysis. Office-based systolic BP reduced by 25.1±23.3 mm Hg (baseline, 174±18 mm Hg; P<0.0001) post-coupler placement, and office diastolic BP reduced by 20.8±13.3 mm Hg (baseline, 100±13 mm Hg; P<0.0001). Mean 24-hour ambulatory BP reduced by 12.6±17.4/15.3±9.7 mm Hg (P<0.0001 for both). In a prespecified subset of patients who failed to respond adequately to prior renal denervation, coupler therapy led to highly significant reduction in office systolic/diastolic BP (30.7/24.1 mm Hg) and significant reduction in 24-hour ambulatory systolic/diastolic BP (12.4/14.4 mm Hg) at 12 months (n=9). After coupler therapy, 14 patients (33%) developed ipsilateral venous stenosis; all were treated successfully with venous stenting. These findings confirm the importance of arterial mechanics in the pathophysiology of hypertension and support the clinical use of a central iliac arteriovenous anastomosis.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Münster Germany (DE) Institute of Cardiology in Warsaw Poland (PL) University of Leicester United Kingdom (GB) ZNA Middelheim Belgium (BE) St. Antonius Ziekenhuis Netherlands (NL) "Hippokration" General Hospital of Athens, Medical School Greece (GR) Cliniques universitaires Saint-Luc (CHU St-Luc) Belgium (BE) Royal Brompton Hospital United Kingdom (GB) East Sussex Healthcare NHS Trust United Kingdom (GB) Charité - Universitätsmedizin Berlin Germany (DE) Connolly Hospital Blanchardstown / Ospidéal Uí Chonghaile, Baile Bhlainséir Ireland (IE) Eastbourne District General Hospital United Kingdom (GB) Columbia University United States (USA) (US) Royal College of Surgeons in Ireland (RCSI) Ireland (IE) The William Harvey Research Institute United Kingdom (GB) Ohio State University United States (USA) (US)

How to cite

APA:

Lobo, M.D., Ott, C., Sobotka, P.A., Saxena, M., Stanton, A., Cockcroft, J.R.,... Schmieder, R. (2017). Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. https://dx.doi.org/10.1161/HYPERTENSIONAHA.117.10142

MLA:

Lobo, Melvin D., et al. "Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial." Hypertension (2017).

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