Pooled Data from RADIANCE Demonstrates Ability of Denervation to Lower Blood Pressure

Ajay Kirtane, MD

Pooled data from the RADIANCE program presented at the American Heart Association 2022 Scientific Sessions further emphasize the potential of endovascular ultrasound renal denervation for management of hypertension.

A pooled analysis of RADIANCE-HTN TRIO, RADIANCE-HTN SOLO, and RADIANCE II, results of the analysis indicate use of endovascular ultrasound renal denervation was associated with a mean overall reduction in daytime ambulatory systolic blood pressure of -8.5 mmHg.

“Pooling the data from the RADIANCE program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing severities of hypertension. The consistent and clinically meaningful blood pressure reduction across multiple patient groups increases our interest in the use of uRDN as a potential therapeutic option, when added to lifestyle modification and medications for our patients with uncontrolled blood pressure,” said study co-principal investigator Ajay Kirtane, MD, professor of medicine at Columbia University, Vagelos College of Physicians and Surgeons and an interventional cardiologist at New York-Presbyterian/Columbia University Irving Medical Center, in a statement.

Hypertension management is a crux of cardiovascular disease prevention, yet ideal blood pressure management escapes millions of patients and providers. As a result, methods, pharmacologic or otherwise, for improving blood pressure management have garnered considerable excitement in recent years. Among these is endovascular ultrasound renal denervation, which has been the subject of multiple trials published in recent years, including those within the RADIANCE Global program.

An international, multicenter initiative designed to examine the Paradise uRDN System, the RADIANCE Global program included RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. The AHA 22 pooled analysis was designed as an individual patient data meta-analysis using linear mixed models to compare randomized treatment arms across the trials, with baseline-adjusted change in 2-month daytime systolic ambulatory pressure between those randomized to Paradise uRDN System and sham. Investigators pointed out secondary outcomes of interest included baseline-adjusted change in other blood pressure measurements and rates of BP control, as well as safety endpoints.

In the pooled analyses, results indicated use of endovascular ultrasound renal denervation was associated with a mean overall reduction in daytime ambulatory systolic blood pressure of -8.5 mmHg (P <.0001) with a difference between treatment and sham arms of -5.9 mmHg (P <.0001) at 2 months. Investigators observed blood pressure results were similarly positive when assessing the 24-hour, nighttime, home, and office measurements. Investigators also pointed out a favorable safety profile was consistently observed across the 3 studies included in the analysis.

“It is very important that the RADIANCE pooled analysis demonstrated a consistent blood pressure reduction in patients across a range of hypertension and both with and without antihypertensive medication, thus broadening the potential applicability of uRDN. Just as important, more than 50% of patients treated with uRDN in the pooled analysis either achieved daytime ambulatory BP control or had a greater than 10 mmHg decrease in daytime ambulatory systolic BP at two months, showing the potential benefits of uRDN as an element of a treatment regimen for patients with uncontrolled hypertension,” said study principal investigator Michel Azizi, professor of medicine at Université Paris Cité in Paris, France, in the aforementioned statement.

This study, “Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO and RADIANCE-HTN TRIO Trials,” was presented at AHA 22.