Efficacy of Ultrasound Renal Denervation Based Upon Changes in Detected Antihypertensive Medications Within the Radiance HTN-Trio Study

Objective: The randomized RADIANCE-HTN TRIO trial assessed the safety and efficacy of ultrasound renal denervation (uRDN) among patients with resistant hypertension (HTN), demonstrating a difference in daytime ambulatory systolic BP (DASBP) of -4.5 mmHg in favor of uRDN over a sham procedure at 2 months. Blood pressure results may be confounded by changes in anti-hypertensive medications (AHM). In this analysis, we assessed the BP-lowering efficacy of uRDN adjusted for detected AHM metabolites at baseline and 2 months. Design and method: Following standardization on a single triple combination antihypertensive pill, patients with daytime ambulatory blood pressure (DABP) 135/85 mmHg or greater were randomized 1:1 to uRDN or sham. Chemical adherence testing was used to detect AHM or their metabolites in spot urine samples under blinding to treatment assignment at baseline and 2 months. Analysis of covariance (ANCOVA) was utilized to assess the 2-month change in DASBP between groups, adjusting for DASBP at baseline and AHM detected at baseline and 2 months. Results: Both DABP and AHM urine metabolite data at baseline and 2 months were available in 100 patients (uRDN n=47; sham n=53). Mean age was 52.6±8.8 years, 23% were female, and 71% were white. At baseline, DASBP was 149±11 mmHg and 2.7±1.2 AHM metabolites were detected. No changes in number of detected drugs between baseline and 2 months were found in 72% of the patients. Between baseline and 2 months, the change in DASBP was -10.9 [95% CI: -15.5, -6.3] mmHg in the uRDN group and -4.0 [-8.0, 0.0] mmHg in the sham group (baseline-adjusted between-group difference: -6.9 [-12.8, -1.1] mmHg; p=0.007). Following additional adjustment for the number of detected AHM at baseline and 2M, the mean between-group difference in DASBP was -9.3 [-14.9, -3.7] mmHg (p=0.0003) in favor of uRDN. Conclusions: The blood pressure-lowering efficacy of uRDN in patients with resistant HTN was maintained and numerically more pronounced when adjusting for changes in detected AHM metabolites.