Abstract-This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in realworld 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-URL: www.clinicaltrials.gov. Unique identifier: NCT01534299 ) in which sympathetic hyperactivity may play a role in addition to and independently of the BP increase.
5Because RDN is an interventional procedure that may expose patients to some risks and could increase costs, large databases on safety and efficacy in clinical practice settings, without the strict inclusion and exclusion criteria and site selection used in clinical trials, are needed. The Global SYMPLICITY registry (GSR) 19 will provide data on periprocedural and renal safety as well as the effectiveness of BP reduction in such a real-world population of patients undergoing RDN. Herein, the GSR investigators report on the 6-month follow-up of the largest group of hypertensive patients to undergo RDN in an uncontrolled global clinical setting.
Methods
DesignThis analysis is based on 998 patients with complete safety and office BP data at baseline and 6 months of follow-up, who underwent RDN from February 1, 2012, to September 9, 2013. One-hundred thirtyfour centers in Canada, Western Europe, Latin America, Eastern Europe, South Africa, Middle East, Asia, Australia, and New Zealand were involved (see online-only Data Supplement).The study design of the prospective, open-label, multicenter GSR has been published previously. 19 In brief, the registry will include ≤5000 patients with hy...