Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program

Azizi M, Sharp AS, Fisher ND, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder R, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 149

Pages Range: 747-759

Journal Issue: 10

DOI: 10.1161/CIRCULATIONAHA.123.066941

Abstract

BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (.6.8, -4.0; P<0.001) and -5.2 mm Hg (.7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs.

Authors with CRIS profile

Involved external institutions

Cedars-Sinai Medical Center United States (USA) (US) Université Sorbonne Paris Cité France (FR) University Hospital of Wales (UHW) United Kingdom (GB) Brigham and Women's Hospital (BWH) United States (USA) (US) State University of New York at Albany (UNY Albany / UAlbany) United States (USA) (US) University of Nevada, Reno United States (USA) (US) Abbott Northwestern Hospital United States (USA) (US) Deborah Heart and Lung Center United States (USA) (US) Ochsner Health System United States (USA) (US) Emory University United States (USA) (US) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux France (FR) North American Science Associates (NAMSA) United States (USA) (US) Cardiovascular Research Foundation United States (USA) (US) Queen Mary, University of London United Kingdom (GB) Erasmus University Medical Center (MC) Netherlands (NL) Universitätsmedizin der Johannes Gutenberg-Universität Mainz Germany (DE) Universitätsklinikum des Saarlandes (UKS) Germany (DE) Medical University of South Carolina (MUSC) United States (USA) (US)

How to cite

APA:

Azizi, M., Sharp, A.S., Fisher, N.D., Weber, M.A., Lobo, M.D., Daemen, J.,... Kirtane, A.J. (2024). Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation, 149(10), 747-759. https://dx.doi.org/10.1161/CIRCULATIONAHA.123.066941

MLA:

Azizi, Michel, et al. "Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program." Circulation 149.10 (2024): 747-759.

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