Evidence map›Paper›PMID 28003251›Full record

Trial reportJournal of the American Heart Association2016

Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.

Christian Ott, Melvin D Lobo, Paul A Sobotka, Felix Mahfoud, Alice Stanton, John Cockcroft, Neil Sulke, Eamon Dolan, Markus van der Giet, Joachim Hoyer and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642498 (ROX CONTROL HTN Study), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01642498 phase3completednot on this map

ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension

TypeinterventionalSponsorROX Medical, Inc.Ran2012 to 2018Enrolled100ConditionsHypertensionArmsROX COUPLER
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Pacemaker-Mediated Programmable Hypertension Control Therapy.Journal of the American Heart Association · 2017
    Trial
  3. Article
  4. Article
  5. Sex hormones impact early maturation and immune response in the arteriovenous fistula mouse model.American journal of physiology. Heart and circulatory physiology · 2023
    Article
  6. Review
  7. Article
  8. Device-based therapies for arterial hypertension.Nature reviews. Cardiology · 2020
    Review
  9. Article
  10. Article
  11. Observational
  12. Article
  13. Review
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 18 institutions in 9 countries.

Christian OttDepartment of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
Melvin D LoboWilliam Harvey Research Institute, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University of London, United Kingdom.
Paul A SobotkaROX Medical, San Clemente, CA.
Felix MahfoudKlinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
Alice StantonMolecular and Cellular Therapeutics, Royal College of Surgeons in Ireland Medical School, Dublin, Ireland.
John CockcroftCardiolgy Department, Wales Heart Research Institute, Cardiff, United Kingdom.
Neil SulkeCardiology Department, Eastbourne District General Hospital, East Sussex, United Kingdom.
Eamon DolanDepartment of Medicine for the Elderly, Connolly Hospital, Dublin, Ireland.
Markus van der GietDepartment of Endocrinology and Nephrology, Universitätsmedizin Berlin, Berlin, Germany.
Joachim HoyerDepartment of Internal Medicine and Nephrology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany.
Stephen S FurnissDepartment of Cardiology, East Sussex Healthcare NHS Trust, East Sussex, United Kingdom.
John P ForanCardiac Department, Royal Brompton Hospital, London, United Kingdom.
Adam WitkowskiInstitute of Cardiology, Warsaw, Poland.
Andrzej JanuszewiczInstitute of Cardiology, Warsaw, Poland.
Danny SchoorsDepartment of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Konstantinos TsioufisDepartment of Cardiology, Hippokration General Hospital of Athens, Greece.
Benno J RensingDepartment of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Manish SaxenaWilliam Harvey Research Institute, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University of London, United Kingdom.
Benjamin ScottDepartment of Cardiology, ZNA - Cardio Middelheim, Antwerp, Belgium.
G André NgDepartment of Cardiovascular Sciences, University of Leicester Glenfield Hospital/NIHR Leicester Cardiovascular Biomedical Research, Leicester, United Kingdom.
Stephan AchenbachDepartment of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
Roland E SchmiederDepartment of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany roland.schmieder@uk-erlangen.de.
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEInstitute of Cardiology · PLQueen Mary University of London · GBConnolly Hospital Blanchardstown · IEEastbourne District General Hospital · GBEast Sussex Healthcare NHS Trust · GBHippocration General Hospital · GRRex Medical (United States) · USRoyal College of Surgeons in Ireland · IESchmid (Germany) · DESt. Antonius Ziekenhuis · NLSt Helier Hospital · GBThe Heart Research Institute · AUUniversitair Ziekenhuis Brussel · BEUniversitätsklinikum des Saarlandes · DEUniversitätsklinikum Gießen und Marburg · DEUniversity of Leicester · GBZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptions 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. METHODS AND

resultsThe 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).

conclusionsOur 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. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.

Indexed as

Arteriovenous Shunt, SurgicalBlood PressureBlood Pressure Monitoring, AmbulatoryFemaleFollow-Up StudiesHumansHypertensionIliac ArteryIliac VeinMaleMiddle AgedProspective StudiesTreatment Outcomearteriovenous anastomosiscombined hypertensionisolated systolic hypertensiontreatment resistant hypertension

Identifiers

PMID28003251
PMCPMC5210451
OpenAlexW2566920747

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.