First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension

Beitrag in einer Fachzeitschrift


Details zur Publikation

Autorinnen und Autoren: Boehm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, Ruilope L, Schlaich MP, Schmieder R, Whitbourn R, Williams B, Zeymer U, Zirlik A, Mancia G
Zeitschrift: Hypertension
Jahr der Veröffentlichung: 2015
Band: 65
Heftnummer: 4
Seitenbereich: 766-74
ISSN: 0194-911X
eISSN: 1524-4563


Abstract

This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, >=160 mm Hg; 24-hour systolic pressure, >=135 mm Hg; and >=3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P<0.001 for both) and -20.3±22.8 and -8.9±16.9 mm Hg for those with severe hypertension (P<0.001 for both). Renal denervation was associated with low rates of adverse events. After the procedure through 6 months, there was 1 new renal artery stenosis >70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures.URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.


FAU-Autorinnen und Autoren / FAU-Herausgeberinnen und Herausgeber

Schmieder, Roland Prof. Dr.
Professur für Innere Medizin (Nephrologie)


Einrichtungen weiterer Autorinnen und Autoren

Hospital Universitario 12 de Octubre
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medical University Gdansk / Gdański Uniwersytet Medyczny
Medtronic
Paracelsus Medizinische Privatuniversität
St Vincent's Hospital
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Universitätsklinikum des Saarlandes
University College London (UCL)
University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB
University of Western Australia (UWA)


Zitierweisen

APA:
Boehm, M., Mahfoud, F., Ukena, C., Hoppe, U.C., Narkiewicz, K., Negoita, M.,... Mancia, G. (2015). First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension, 65(4), 766-74. https://dx.doi.org/10.1161/HYPERTENSIONAHA.114.05010

MLA:
Boehm, Michael, et al. "First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension." Hypertension 65.4 (2015): 766-74.

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Zuletzt aktualisiert 2018-10-10 um 08:19