A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN)

TLDR

Both radiofrequency and ultrasound endovascular renal sympathetic denervation have proven clinical efficacy for treating hypertension. The study compared these two technologies in patients with resistant hypertension by randomizing them into three groups: radiofrequency ablation of the main renal arteries, combined radiofrequency ablation of main arteries and side branches, and endovascular ultrasound‑based ablation of the main renal artery. In a 1:1:1 randomized trial of 120 patients, the primary endpoint was the change in systolic daytime ambulatory blood pressure at 3 months. At 3 months, systolic daytime ambulatory blood pressure fell by 9.5 mm Hg overall, with the ultrasound group showing a significantly greater reduction than the main‑artery radiofrequency group (−13.2 mm Hg vs −6.5 mm Hg, mean difference −6.7 mm Hg), while no differences were seen between the two radiofrequency groups or between ultrasound and side‑branch groups. The trial is registered under NCT02920034 on clinicaltrials.gov.

Abstract

Both radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have proven clinical efficacy for the treatment of hypertension. We performed a head-to-head comparison of these technologies.Patients with resistant hypertension were randomly assigned in a 1:1:1 manner to receive either treatment with (1) radiofrequency RDN of the main renal arteries; (2) radiofrequency RDN of the main renal arteries, side branches, and accessories; or (3) an endovascular ultrasound-based RDN of the main renal artery. The primary end point was change in systolic daytime ambulatory blood pressure at 3 months.Between June 2015 and June 2018, 120 patients were enrolled (mean age, 64±9 years±SD; mean daytime blood pressure, 153/86±12/13 mm Hg). Of these, 39 were randomly assigned to radiofrequency main renal artery ablation, 39 to combined radiofrequency ablation of the main artery and branches, and 42 to ultrasound-based treatment. Baseline daytime blood pressure, clinical characteristics, and treatment were well balanced between the groups. At 3 months, systolic daytime ambulatory blood pressure decreased by 9.5±12.3 mm Hg ( P<0.001) in the whole cohort. Although blood pressure was significantly more reduced in the ultrasound ablation group than in the radiofrequency ablation group of the main renal artery (-13.2±13.7 versus -6.5±10.3 mm Hg; mean difference, -6.7 mm Hg; global P=0.038 by ANOVA, adjusted P=0.043), no significant difference was found between the radiofrequency ablation groups (-8.3±11.7 mm Hg for additional side branch ablation; mean difference, -1.8 mm Hg; adjusted P>0.99). Similarly, the blood pressure reduction was not found to be significantly different between the ultrasound and the side branch ablation groups. Frequencies of blood pressure response ≥5 mm Hg were not significantly different (global P=0.77).In patients with resistant hypertension, endovascular ultrasound-based RDN was found to be superior to radiofrequency ablation of the main renal arteries only, whereas a combined approach of radiofrequency ablation of the main arteries, accessories, and side branches was not.URL: https://www.clinicaltrials.gov . Unique identifier: NCT02920034.