• RADIANCE II: Ultrasound RDN Safely, Effectively Lowers Blood Pressure

    Endovascular ultrasound renal denervation (uRDN) lowers blood pressure (BP) safely and effectively, according to results from the pivotal RADIANCE II trial.

    Ajay J. Kirtane, MD, SM, of New York-Presbyterian/Columbia University Irving Medical Center, presented these findings Sunday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston. 

    Between March 2019 and May 2022, a total of 150 patients received uRDN and 74 underwent a sham procedure.

    Baseline characteristics including ambulatory blood pressure and the number of anti-hypertensive medications were similar between patients in both groups.

    Patients with hypertension (seated office BP ≥140/90 mmHg and <180/120 mmHg) on no more than two antihypertensive medications underwent a 4-week observation time during which they were taken off all hypertension medications. Those who remained clinically stable after the observation period and whose BP remained elevated with daytime ambulatory systolic BP (ASBP) ≥135/85 mmHg but <170/105 mmHg underwent anatomic screening with computed tomography angiography/magnetic resonance angiography. Those with qualifying renal artery anatomy proceeded to renal angiography, and if angiography re-confirmed suitability for uRDN, they were then randomized 2:1 to receive bilateral uRDN of the main and accessory (≥3 mm) renal arteries or a sham procedure.  

    The primary efficacy endpoint was the change in ASBP at 2 months. The change in ASBP was -7.9 mmHg for the uRDN group compared to -1.8mmHg for the sham group. The between-group difference was -6.3 mmHg (95% confidence interval [CI] -9.3 to -3.2, p<0.0001). In addition, the secondary efficacy endpoints of change in 24-hour, nighttime, home, and office systolic BP showed statistically and clinically significant reductions (change of 5-7 mmHg versus sham). There were also no major adverse events in either group through 30 days. 

    These results are concordant with those of the RADIANCE-HTN SOLO and RADIANCE-HTN TRIO trials, confirming that uRDN lowers blood pressure across the spectrum of hypertension, Kirtane said. 

    “These positive outcomes build upon prior trial results demonstrating that uRDN lowers blood pressure across the spectrum of hypertension,” Kirtane said in a press release announcing the study results. “This is an important next step in providing optimal care for patients and we look forward to continuing research to determine whether the blood pressure lowering effect of uRDN remains durable and safe over time.”

    The study was funded by ReCor Medical Inc., the manufacturer of the renal denervation device used in the study.

    Image Credit: Jason Wermers/CRTonline.org

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