TY - JOUR
T1 - First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension
AU - Böhm, Michael
AU - Mahfoud, Felix
AU - Ukena, Christian
AU - Hoppe, Uta C.
AU - Narkiewicz, Krzysztof
AU - Negoita, Manuela
AU - Ruilope, Luis
AU - Schlaich, Markus P.
AU - Schmieder, Roland E.
AU - Whitbourn, Robert
AU - Williams, Bryan
AU - Zeymer, Uwe
AU - Zirlik, Andreas
AU - Mancia, Giuseppe
PY - 2015/4/20
Y1 - 2015/4/20
N2 - 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 (P70% 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 - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.
AB - 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 (P70% 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 - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.
KW - denervation
KW - hypertension
KW - sympathetic nervous system
UR - http://www.scopus.com/inward/record.url?scp=84929130721&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84929130721&partnerID=8YFLogxK
U2 - 10.1161/HYPERTENSIONAHA.114.05010
DO - 10.1161/HYPERTENSIONAHA.114.05010
M3 - Article
C2 - 25691618
AN - SCOPUS:84929130721
VL - 65
SP - 766
EP - 774
JO - Hypertension
JF - Hypertension
SN - 0194-911X
IS - 4
ER -