RADIANCE II: Is uRDN Superior to Sham in Lowering BP in Patients With Uncontrolled HTN?
Endovascular ultrasound renal denervation (uRDN) was superior in lowering blood pressure (BP) compared with a sham procedure inpatients with uncontrolled mild-to-moderate hypertension (HTN), based on findings from the RADIANCE II Pivotal trial presented Sept. 18 during TCT 2022 in Boston.
The trial randomized 224 patients to either uRDN (n=150) or a sham procedure (n=74). All patients had HTN (seated office BP ≥140/90 mmHg and <180/120 mmHg) and were on no more than two anti-HTN medications. Prior to randomization, all also underwent a four-week observation time during which they were taken off all HTN medications. Those who remained clinically stable after the observation period and whose BP remained elevated with daytime ambulatory systolic BP (ASBP) greater than or equal to 135/85 mmHg but less than 170/105 mmHg underwent further screening to determine suitability for uRDN. The primary efficacy endpoint was the change in ASBP at two months.
Overall findings found the change in ASBP was -7.9 mmHg for the uRDN group compared to -1.8mmHg for the sham group, with a between group difference of -6.3 mmHg. In addition, researchers observed statistically and clinically significant reductions in the secondary efficacy endpoints of change in 24-hour, nighttime, home, and office systolic BP. No major adverse events occurred in either group through 30 days.
According to Ajay J. Kirtane, MD, SM, FACC, the results are concordant with those of RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. "These positive outcomes build upon prior trial results demonstrating that uRDN lowers BP across the spectrum of hypertension," he said. "This is an important next step in providing optimal care for patients and we look forward to continuing research to determine whether the BP lowering effect of uRDN remains durable and safe over time."
Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Hypertension, Sympathectomy
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