#VisualAbstract: Ultrasound renal denervation lowered daytime ambulatory systolic blood pressure among patients with hypertension

1. In this sham-controlled, randomized clinical trial, among 224 patients with hypertension, ultrasound renal denervation demonstrated clinically relevant reductions in daytime ambulatory systolic blood pressure (SBP) compared to the sham procedure.

2. Among seven secondary blood pressure outcomes, including mean change in 24-hr SBP, home SBP, office SBP, and all diastolic blood pressure parameters at 2 months, six outcomes were significantly improved with ultrasound renal denervation vs the sham procedure.

Evidence Rating Level:1 (Excellent)

Study Rundown: There is an increasing prevalence of poorly controlled hypertension globally, with many patients receiving inadequate treatment. Endovascular, catheter-based renal denervation has been studied as an adjunctive treatment to lower blood pressure (BP); however, there is inconsistency among the results. The RADIANCE II trial investigated the efficacy and safety of ultrasound renal denervation in patients withdrawn from antihypertensive medications. This sham-controlled, randomized clinical trial was conducted between January 2019 and March 2022 at centers in the United States (US) and Europe. Participants were randomized to receive either ultrasound renal denervation (n=150) or a sham procedure (n=74). The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. There was a greater reduction in daytime ambulatory SBP with ultrasound renal denervation (mean, -7.9mmHg) compared to the sham procedure (mean, -1.8mmHg), consistent over the 24-hour circadian cycle. There were no major adverse events in either group. Consistent average reductions in 6 of 7 prespecified secondary BP outcomes at 2 months, including 24-hour SBP, and home and office SBP were achieved after ultrasound renal denervation. A major strength of this study was its rigorous methodology. The generalizability of this study was limited, however, due to the enrollment of patients at low cardiovascular risk with an estimated glomerular filtration rate (eGFR) of 40mL/min/1.73m² or greater, without significant comorbidities.

Click to read the study in JAMA

Click to read an accompanying editorial in JAMA

Relevant Reading: A controlled trial of renal denervation for resistant hypertension