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 The RADIANCE II trial investigated the efficacy and safety of ultrasound renal denervation in patients withdrawn from antihypertensive medications.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
In-Depth [randomized controlled trial]: This sham-controlled, randomized clinical trial investigated the efficacy and safety of ultrasound renal denervation in patients withdrawn from antihypertensive medications. Patients were recruited between January 2019 and March 2022, with random stratification occurring at 37 centers in the US and 24 centers in Europe. Patients with an eGFR of 40mL/min/1.73m2 or greater with suitable renal artery anatomy were randomized 2:1 to receive ultrasound renal denervation or a sham procedure. Patients were required to abstain from antihypertensive medications until the 2-month follow-up period. Patients were randomized to receive either ultrasound renal denervation (n=150) or a sham procedure (n=74) (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. Secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. A greater reduction in daytime ambulatory SBP was seen in the ultrasound renal denervation group (mean, -7.9mmHg [SD, 11.6 mmHg]) vs the sham procedure (mean, -1.8mmHg [SD, 9.5 mmHg]) (baseline adjusted between-group difference, -6.3 mmHg [95% CI, -9.3 to -3.2 mmHg], P < .001). There were no major adverse events reported in either group. Regarding primary safety composite outcomes, no renal artery stenosis greater than 70% was detected.
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