Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial.
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| Title: | Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. |
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| Authors: | Lobo, Melvin D., Sobotka, Paul A., Stanton, Alice, Cockcroft, John R., Sulke, Neil, Dolan, Eamon, van der Giet, Markus, Hoyer, Joachim, Furniss, Stephen S., Foran, John P., Witkowski, Adam, Januszewicz, Andrzej, Schoors, Danny, Tsioufis, Konstantinos, Rensing, Benno J., Scott, Benjamin, Ng, G. André, Ott, Christian, Schmieder, Roland E. |
| Source: | Lancet. 4/25/2015, Vol. 385 Issue 9978, p1634-1641. 8p. 1 Color Photograph, 1 Diagram, 3 Charts, 2 Graphs. |
| Subjects: | Arteriovenous anastomosis, Hypertension, Blood pressure, Antihypertensive agents, Cardiovascular diseases |
| 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. 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. INSET: Panel: Research in context.. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 102353475 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Lobo%2C+Melvin+D%2E%22">Lobo, Melvin D.</searchLink><br /><searchLink fieldCode="AR" term="%22Sobotka%2C+Paul+A%2E%22">Sobotka, Paul A.</searchLink><br /><searchLink fieldCode="AR" term="%22Stanton%2C+Alice%22">Stanton, Alice</searchLink><br /><searchLink fieldCode="AR" term="%22Cockcroft%2C+John+R%2E%22">Cockcroft, John R.</searchLink><br /><searchLink fieldCode="AR" term="%22Sulke%2C+Neil%22">Sulke, Neil</searchLink><br /><searchLink fieldCode="AR" term="%22Dolan%2C+Eamon%22">Dolan, Eamon</searchLink><br /><searchLink fieldCode="AR" term="%22van+der+Giet%2C+Markus%22">van der Giet, Markus</searchLink><br /><searchLink fieldCode="AR" term="%22Hoyer%2C+Joachim%22">Hoyer, Joachim</searchLink><br /><searchLink fieldCode="AR" term="%22Furniss%2C+Stephen+S%2E%22">Furniss, Stephen S.</searchLink><br /><searchLink fieldCode="AR" term="%22Foran%2C+John+P%2E%22">Foran, John P.</searchLink><br /><searchLink fieldCode="AR" term="%22Witkowski%2C+Adam%22">Witkowski, Adam</searchLink><br /><searchLink fieldCode="AR" term="%22Januszewicz%2C+Andrzej%22">Januszewicz, Andrzej</searchLink><br /><searchLink fieldCode="AR" term="%22Schoors%2C+Danny%22">Schoors, Danny</searchLink><br /><searchLink fieldCode="AR" term="%22Tsioufis%2C+Konstantinos%22">Tsioufis, Konstantinos</searchLink><br /><searchLink fieldCode="AR" term="%22Rensing%2C+Benno+J%2E%22">Rensing, Benno J.</searchLink><br /><searchLink fieldCode="AR" term="%22Scott%2C+Benjamin%22">Scott, Benjamin</searchLink><br /><searchLink fieldCode="AR" term="%22Ng%2C+G%2E+André%22">Ng, G. André</searchLink><br /><searchLink fieldCode="AR" term="%22Ott%2C+Christian%22">Ott, Christian</searchLink><br /><searchLink fieldCode="AR" term="%22Schmieder%2C+Roland+E%2E%22">Schmieder, Roland E.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 4/25/2015, Vol. 385 Issue 9978, p1634-1641. 8p. 1 Color Photograph, 1 Diagram, 3 Charts, 2 Graphs. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Arteriovenous+anastomosis%22">Arteriovenous anastomosis</searchLink><br /><searchLink fieldCode="DE" term="%22Hypertension%22">Hypertension</searchLink><br /><searchLink fieldCode="DE" term="%22Blood+pressure%22">Blood pressure</searchLink><br /><searchLink fieldCode="DE" term="%22Antihypertensive+agents%22">Antihypertensive agents</searchLink><br /><searchLink fieldCode="DE" term="%22Cardiovascular+diseases%22">Cardiovascular diseases</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. INSET: Panel: Research in context.. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/S0140-6736(14)62053-5 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 8 StartPage: 1634 Subjects: – SubjectFull: Arteriovenous anastomosis Type: general – SubjectFull: Hypertension Type: general – SubjectFull: Blood pressure Type: general – SubjectFull: Antihypertensive agents Type: general – SubjectFull: Cardiovascular diseases Type: general Titles: – TitleFull: Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Lobo, Melvin D. – PersonEntity: Name: NameFull: Sobotka, Paul A. – PersonEntity: Name: NameFull: Stanton, Alice – PersonEntity: Name: NameFull: Cockcroft, John R. – PersonEntity: Name: NameFull: Sulke, Neil – PersonEntity: Name: NameFull: Dolan, Eamon – PersonEntity: Name: NameFull: van der Giet, Markus – PersonEntity: Name: NameFull: Hoyer, Joachim – PersonEntity: Name: NameFull: Furniss, Stephen S. – PersonEntity: Name: NameFull: Foran, John P. – PersonEntity: Name: NameFull: Witkowski, Adam – PersonEntity: Name: NameFull: Januszewicz, Andrzej – PersonEntity: Name: NameFull: Schoors, Danny – PersonEntity: Name: NameFull: Tsioufis, Konstantinos – PersonEntity: Name: NameFull: Rensing, Benno J. – PersonEntity: Name: NameFull: Scott, Benjamin – PersonEntity: Name: NameFull: Ng, G. André – PersonEntity: Name: NameFull: Ott, Christian – PersonEntity: Name: NameFull: Schmieder, Roland E. IsPartOfRelationships: – BibEntity: Dates: – D: 25 M: 04 Text: 4/25/2015 Type: published Y: 2015 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 385 – Type: issue Value: 9978 Titles: – TitleFull: Lancet Type: main |
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