12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.

OBJECTIVES

This 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.

BACKGROUND

The 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.

METHODS

Patients 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.

RESULTS

Sixty-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.

CONCLUSIONS

Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.

Informations de copyright

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Author Disclosures This work was supported by ReCor Medical. Dr. Azizi has received research grants from the French Ministry of Health, Quantum Genomics, and the European Horizon 2020 program; has received grant support and nonfinancial support from ReCor Medical and Idorsia; and has received personal fees from CVRx. Dr. Daemen has received grant support from ReCor Medical, Medtronic, Boston Scientific, Abbott Vascular, Acist Medical, AstraZeneca, Pie Medical, and Pulse Cath; and has received personal fees from ReCor Medical, Medtronic, Acist Medical, Boston Scientific, Pie Medical, and Pulse Cath. Dr. Lobo has received personal fees from ReCor Medical, Medtronic, CVRx, Ablative Solutions, Vascular Dynamics, ROX Medical, and Tarilan Laser Technologies; and has received grants from Medtronic. Dr. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie, Deutsche Hochdruckliga, and Deutsche Forschungsgemeinschaft (SFB TRR 219); and has received grant support and personal fees from ReCor Medical, Medtronic, Berlin Chemie, Bayer, and Boehringer Ingelheim. Dr. Sharp has received personal fees from ReCor Medical, Medtronic, and Philips. Dr. Schmieder has received grant support and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. Dr. Saxena has received grant support and personal fees from ReCor Medical. Dr. Lurz has received grant support and personal fees from ReCor Medical, Edwards Lifesciences, and Abbott; and has received personal fees from Medtronic and Occlutech. Dr. Bloch has received personal fees from ReCor Medical and Medtronic. Dr. Basile has received grant support from ReCor Medical and Ablative Solutions. Dr. Weber has received personal fees from ReCor Medical, Medtronic, Boston Scientific, and Ablative Solutions. Dr. Rump has received personal fees and other support from ReCor Medical. Dr. Sanghvi has received grant support and personal fees from ReCor Medical and Medtronic; and has received grant support from CSI. Dr. Rader has received other support from ReCor Medical. Dr. Fisher has received grant support and personal fees from ReCor Medical. Dr. Gosse has received grant support from the University Hospital of Bordeaux. Ms. Claude is an employee of ReCor Medical. Dr. Barman is an employee of ReCor Medical; and holds multiple patents in renal denervation. Dr. McClure is an employee of NAMSA, a contractor for ReCor Medical. Dr. Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Philips, and ReCor Medical; and has received personal fees for continuing medical education, conference honoraria, and travel and meals only. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.