Details

Autor(en) / Beteiligte

• Azizi, Michel
• Sharp, Andrew S P
• Fisher, Naomi D L
• Weber, Michael A
• Lobo, Melvin D
• Daemen, Joost
• Lurz, Philipp
• Mahfoud, Felix
• Schmieder, Roland E
• Basile, Jan
• Bloch, Michael J
• Saxena, Manish
• Wang, Yale
• Sanghvi, Kintur
• Jenkins, J Stephen
• Devireddy, Chandan
• Rader, Florian
• Gosse, Philippe
• Claude, Lisa
• Augustin, Dimitri A
• McClure, Candace K
• Kirtane, Ajay J

Titel

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

Ist Teil von

• Circulation (New York, N.Y.), 2024-03, Vol.149 (10), p.747-759

Ort / Verlag

United States

Erscheinungsjahr

2024

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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. 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 ( =0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients ( =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; =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; <0.001) and -5.2 mm Hg (-7.1, -3.3; <0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. 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. URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.