Ultrasound renal denervation (uRDN) was found to reduce blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension (RHTN) taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. This was despite early trials of endovascular RDN renal denervation (RDN) for patients with RHTN reporting inconsistent results. The purpose of this study was to present the results of a prespecified analysis comparing the efficacy and safety of uRDN to those of a sham treatment for controlling blood pressure over a 6-month period while increasing the dosage of standard antihypertensive drugs. Patients were enrolled from March 11, 2016, to March 13, 2020, for this randomized, sham-controlled clinical trial with outcome assessors and patients blinded to treatment assignment. This study involved multiple locations across the United States and Europe.
Patients with an estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or higher and a daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) were randomly assigned to uRDN or sham, with medications unchanged through 2 months. Standardized stepped-care antihypertensive medication, beginning with aldosterone antagonists, was initiated between 2 and 5 months if home BP was 135/85 mm Hg or above, without regard to treatment assignment. Medication changes, systolic blood pressure (BP) changes, and BP changes at home after adjusting for baseline BP and medications were all measured and compared to one another after 6 months. At 6 months, ambulatory BP was measured in 65 of 69 people in the uRDN group and 64 of 67 people in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with an eGFR of 81.5 [22.8%] mL/min/1.73 m2. At 6 months, fewer patients in the uRDN group had received aldosterone antagonists (26 of 65 [40.0%] vs. 39 of 64 [60.9%]; P=.02), and fewer drugs were added in the uRDN group (mean [SD], 0.7 [1.0] medications) compared to the sham group (mean [SD], 1.1 [1.1] medications; P=.045).
Daytime ambulatory blood pressure was lower (6 months) with uRDN (138.3 [15.1] mm Hg) than with sham (139.0 [14.3] mm Hg) despite receiving less intensive standardized stepped-care antihypertensive treatment (additional decreases of −2.4 [16.6] vs. −7.0 [16.7] mm Hg from month 2, respectively), and home systolic blood pressure was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P= .03) in a mixed model adjusting for baseline and number of medications. Both groups experienced a similar rate and severity of adverse events. Standardized stepped-care antihypertensive treatment escalation resulted in similar BP reductions in both groups at 6 months, with fewer additional medications required in the uRDN group. This study compared the effectiveness of uRDN and a sham procedure in patients with RHTN who were initially randomly assigned to either treatment.