• Renal Disease
• Hypertension & Kidney Disease
• Hypertensive Disease
• Cardiology Clinical Trials
• Interventional Techniques & Devices

• Renal Disease
• Hypertension & Kidney Disease
• Hypertensive Disease
• Cardiology & Cardiovascular Medicine
• Cardiology Clinical Trials
• Interventional Techniques & Devices

Systolic daytime ambulatory blood pressure (BP) was significantly decreased by renal denervation plus standardized medical treatment with the Symplicity catheter compared with standardized medical treatment alone in patients with confirmed resistant hypertension. Michel Azizi, MD, PhD, Hôpital Européen Georges Pompidou, Paris, France, presented 6-month data from the multicenter Renal Denervation in Hypertension study [DENER-HTN; NCT01570777]

The Symplicity catheter system delivers radiofrequency energy to target nerves through the renal artery wall to reduce sympathetic nervous system involvement in hypertension [Medtronic 2013]. The purpose of the open-label DENER-HTN trial was to evaluate the safety, efficacy, and cost-effectiveness of renal denervation with the single-electrode Symplicity catheter for patients with resistant hypertension.

In the parallel superiority DENER-HTN trial, 106 patients with resistant hypertension were randomly assigned to receive renal denervation or 4 weeks of standardized therapy alone, after 4 weeks of standardized therapy did not reduce BP to <135/85 mm Hg. Resistant hypertension was defined as office BP of 140/90 mm Hg despite stable antihypertensive therapy with ≥3 medications. All patients received new, standardized treatment for hypertension that included indapamide (1.5 mg), ramipril (10 mg, or irbesartan, if cough present), and amlodipine (10 mg) daily.

The primary endpoint of the trial was changes in daytime ambulatory systolic BP at 6 months. At baseline, the mean office BP was 163/95 mm Hg, and the daytime ambulatory BP was 153.9/93.0 mm Hg. The mean body mass index was 30.1 kg/m², and the mean glomerular filtration rate was 88.6 mL/minute. Patients were monitored with home BP; if the home BP was not <135/85 mm Hg at 2 months, then the patient received spironolactone (25 mg) daily. If BP was still not controlled by 3, 4, or 5 months, patients also received bisoprolol, prazosin, and rilmenidine, respectively.

Patients who underwent renal denervation experienced a significant decrease in systolic BP of 16 mm Hg and the treatment-only group experienced a decrease of 10 to 14 mm Hg, with a difference between the 2 arms of −5.9 mm Hg at 6 months (95% CI, −11 to −0.05; p=0.03). In addition, nighttime ambulatory BP decreased by 6 mm Hg. The proportion of patients who achieved BP <135/85 mm Hg at 6 months was 42% in the renal denervation arm compared with 28% in the standardized treatment only arm; however, this was not significant. In both arms of the study at 6 months, >85% of patients required ≥4 antihypertensive agents, with about 30% requiring 7 antihypertensives.

Dr. Azizi concluded by stating that data from the DENER-HTN trial show that renal denervation with the Symplicity catheter results in a significant reduction in systolic daytime ambulatory BP in patients with resistant hypertension.

• © 2014 MD Conference Express®