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

Autor(en): 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-Autoren / FAU-Herausgeber

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


Autor(en) der externen Einrichtung(en)
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 London)
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