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

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 (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Hypertension American Heart Association

Book Volume: 65

Pages Range: 766-74

Journal Issue: 4

DOI: 10.1161/HYPERTENSIONAHA.114.05010

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.

Authors with CRIS profile

Roland Schmieder Professur für Innere Medizin (Nephrologie)

Involved external institutions

University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB IT Italy (IT) Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH DE Germany (DE) Klinikum der Stadt Ludwigshafen am Rhein gGmbH DE Germany (DE) University College London (UCL) GB United Kingdom (GB) St Vincent's Hospital AU Australia (AU) University of Western Australia (UWA) AU Australia (AU) Hospital Universitario 12 de Octubre ES Spain (ES) Medtronic IE Ireland (IE) Medical University Gdansk / Gdański Uniwersytet Medyczny PL Poland (PL) Paracelsus Medizinische Privatuniversität AT Austria (AT) Universitätsklinikum des Saarlandes (UKS) DE Germany (DE)

How to cite

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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