Details

Autor(en) / Beteiligte

• Böhm, Michael
• Mahfoud, Felix
• Ukena, Christian
• Hoppe, Uta C
• Narkiewicz, Krzysztof
• Negoita, Manuela
• Ruilope, Luis
• Schlaich, Markus P
• Schmieder, Roland E
• Whitbourn, Robert
• Williams, Bryan
• Zeymer, Uwe
• Zirlik, Andreas
• Mancia, Giuseppe

Titel

First Report of the Global SYMPLICITY Registry on the Effect of Renal Artery Denervation in Patients With Uncontrolled Hypertension

Ist Teil von

• Hypertension (Dallas, Tex. 1979), 2015-04, Vol.65 (4), p.766-774

Ort / Verlag

United States: American Heart Association, Inc

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. CLINICAL TRIAL REGISTRATION—URLwww.clinicaltrials.gov. Unique identifierNCT01534299