• Michel Azizi, Joost Daemen, Melvin D Lobo, Felix Mahfoud, SharpAndrew S PASPUniversity Hospital of Wales, Cardiff and University of Exeter, Exeter, United Kingdom., Roland E Schmieder, Yale Wang, Manish Saxena, Philipp Lurz, Jeremy Sayer, Michael J Bloch, Jan Basile, Michael A Weber, Lars C Rump, Terry Levy, Marc Sapoval, Kintur Sanghvi, Florian Rader, Naomi D L Fisher, Philippe Gosse, Josephine Abraham, Lisa Claude, Neil C Barman, Candace K McClure, Yuyin Liu, Ajay J Kirtane, and RADIANCE-HTN Investigators.
• Université de Paris, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France; INSERM, CIC1418, Paris, France. Electronic address: michel.azizi@aphp.fr.
• JACC Cardiovasc Interv. 2020 Dec 28; 13 (24): 2922-2933.

ObjectivesThis study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.BackgroundThe blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.MethodsPatients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.ResultsSixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography.ConclusionsDespite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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