February 18, 2015Hypertension188 citations
View Full PaperFirst Report of the Global SYMPLICITY Registry on the Effect of Renal Artery Denervation in Patients With Uncontrolled Hypertension
Key Result
Renal denervation using the Symplicity system significantly reduced office and 24-hour systolic blood pressures by -11.6 and -6.6 mm Hg, respectively, at 6 months (P<0.001 for both).
Study Design
Type
Observational (n=998)
Blinding
Open-label
Multicenter
Yes
Structured PICO
Does renal denervation using the Symplicity system reduce blood pressure in patients with uncontrolled hypertension?
P
Population
998 patients with uncontrolled hypertension, including a cohort of 323 patients with severe hypertension (office systolic pressure ≥160 mm Hg, 24-hour systolic pressure ≥135 mm Hg, and ≥3 antihypertensive medication classes).
I
Intervention
Renal denervation using the Symplicity system
O
Outcome
Change from baseline to 6 months in office and 24-hour ambulatory blood pressuressurrogate
In a real-world global registry, renal denervation significantly reduced office and 24-hour ambulatory blood pressures at 6 months with a favorable safety profile in patients with uncontrolled hypertension.
Main Result
p-value: p=<0.001
Abstract
UNLABELLED: 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.