{"id":"14304b9ffa17","type":"article","url":"https://hartvaat.nl/2024/03/05/radiance-gepoolde-analyse-ultrageluid-renale-denervatie-na-medicatie-optitratie/","title":"RADIANCE gepoolde analyse: ultrageluid renale denervatie na medicatie-optitratie","title_en":"Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["fidelity","radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066941","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066941","authors":["Michel Azizi","Andrew S P Sharp","Naomi D L Fisher","Michael A Weber","Melvin D Lobo","Joost Daemen","Philipp Lurz","Felix Mahfoud","Roland E Schmieder","Jan Basile","Michael J Bloch","Manish Saxena","Yale Wang","Kintur Sanghvi","J Stephen Jenkins","Chandan Devireddy","Florian Rader","Philippe Gosse","Lisa Claude","Dimitri A Augustin","Candace K McClure","Ajay J Kirtane"],"significance":7,"published":"2024-03-05","source_date":"2024-03-05","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This pooled patient-level RADIANCE analysis confirmed that ultrasound renal denervation provides additive blood pressure reduction when initiated after medication optimization, demonstrating a consistent device effect on top of pharmacotherapy.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gepoolde patiënt-niveau analyse van RADIANCE bevestigde het additionele bloeddrukverlagende effect van ultrageluid RDN na medicatie-optitratie. Het effect is klinisch relevant en consistent over subgroepen.","abstract_original":"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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260."}