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

Title: Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.
Authors: Azizi, M; Sharp, ASP; Fisher, NDL; Weber, MA; Lobo, MD; Daemen, J; Lurz, P; Mahfoud, F; Schmieder, RE; 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; RADIANCE Investigators
Publisher Information: Lippincott Williams & Wilkins
Publication Year: 2024
Collection: Queen Mary University of London: Queen Mary Research Online (QMRO)
Subject Terms: ablation; catheter; antihypertensive drugs; blood pressure; denervation; hypertension; renal; Female; Humans; Male; Antihypertensive Agents; Blood Pressure Monitoring; Ambulatory; Kidney; Renal Artery; Sympathectomy; Treatment Outcome; Middle Aged
Description: 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
Document Type: article in journal/newspaper
File Description: 747 - 759
Language: English
Relation: Circulation; https://qmro.qmul.ac.uk/xmlui/handle/123456789/101285
DOI: 10.1161/CIRCULATIONAHA.123.066941
Availability: https://qmro.qmul.ac.uk/xmlui/handle/123456789/101285; https://doi.org/10.1161/CIRCULATIONAHA.123.066941
Rights: © 2023 American Heart Association, Inc.
Accession Number: edsbas.7AD0A4F8
Database: BASE