Ultrasound Renal Denervation Shows Short-Term Blood Pressure-Lowering Efficacy

Ultrasound renal denervation lowers systolic blood pressure in patients with mild to moderate hypertension or resistant hypertension, according to recent studies.

In the RADIANCE II trial (A Study of the ReCor Medical Paradise System in Stage II Hypertension), ultrasound renal denervation reduced mean daytime ambulatory systolic blood pressure significantly more than sham renal angiography at 2 months: 7.9 vs 1.8 mm Hg, Michel Azizi, MD, PhD, of Université Paris Cité in Paris, France, and colleagues reported in JAMA. The team observed consistent effects during the day, overnight, and early morning.The trial included 224 patients with stage 2 hypertension despite use of up to 2 antihypertensive medications (150 in the ultrasound renal denervation group and 74 in the sham group). Antihypertensive medications were withdrawn for the trial.

In a separate study published in JAMA Cardiology, investigators pooled data from 3 RADIANCE trials (RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO) involving 506 patients (293 who received ultrasound renal denervation and 213 who had a sham procedure). Ultrasound renal denervation consistently lowered systolic blood pressure during the day and night compared with the sham procedure despite varying hypertension severity. At 2 months, mean daytime ambulatory systolic blood pressure decreased significantly more in the renal denervation than sham group: 8.5 vs 2.9 mm Hg, Ajay J. Kirtane, MD, of Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation in New York City and colleagues reported.

The RADIANCE-HTN SOLO trial included patients with mild to moderate hypertension whose blood pressure was controlled or uncontrolled with 0 to 2 medications before withdrawal of antihypertensive medications. The RADIANCE-HTN TRIO trial included patients with resistant hypertension taking 3 or more antihypertensive medications.

Across all trials, adult patients were required to have an estimated glomerular filtration rate of at least 40 mL/min/1.73 m² with suitable renal artery anatomy. They had no significant comorbidities and low cardiovascular risk.

In the RADIANCE II trial, no major adverse events or renal artery stenosis greater than 70% occurred. In the pooled analysis, 1 periprocedural vasovagal event and a vascular access complication with sequelae occurred in the ultrasound renal denervation group. One unrelated death also occurred in the intervention group.

In an accompanying editorial, editors at JAMA Cardiology characterized the magnitude of blood pressure reduction attributable to ultrasound renal denervation as similar to the addition of a single drug class or lifestyle modifications. Its role in treating hypertension still needs to be determined.

“In anticipation of possible near-term approval from the US Food and Drug Administration for renal denervation, there must be an insistence on longer-term clinical outcomes and safety data,” according to Clyde W. Yancy, MD, MSc, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, and colleagues. “Disease-modifying, readily available, and easily affordable medical therapies for hypertension are ubiquitous and set a high bar for any new therapeutic.”

Disclosure: This research was supported by ReCor Medical Inc. Please see the original references for a full list of disclosures.

This article originally appeared on Renal and Urology News