Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial

DOI: 10.4244/EIJ-D-22-00305

Florian Rader
Florian Rader1, MD, MSc; Ajay J. Kirtane2, MD, SM; Yale Wang3, MD; Joost Daemen4, MD, PhD; Philipp Lurz5, MD, PhD; Jeremy Sayer6, MD, FRCP; Manish Saxena7, MBBS, MSc; Terry Levy8, FRCP, MB ChB; Andrea P. Scicli9, PhD; Lisa Thackeray10, MS; Michel Azizi11, MD, PhD; Michael A. Weber12, MD
1. Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, USA; 2. Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA; 3. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA; 4. Erasmus MC, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, the Netherlands; 5. Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany; 6. The Essex Cardiothoracic Centre, Essex, UK; 7. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK; 8. Royal Bournemouth Hospital, Bournemouth, UK; 9. ReCor Medical, Inc., Palo Alto, CA, USA; 10. NAMSA, Minneapolis, MN, USA; 11. Université de Paris, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France; INSERM, CIC1418, Paris, France; 12. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, NY, USA

Background: While the blood pressure (BP)-lowering effect of renal denervation (RDN) has been established, long-term durability is a key prerequisite for a broader clinical implementation.

Aims: Our aims were to assess the long-term durability of the office BP (OBP)-lowering efficacy, antihypertensive medication (AHM) use, and safety of ultrasound RDN (uRDN).

Methods: Four weeks after withdrawal of AHM, patients with untreated daytime ambulatory BP ≥135/85 mmHg and <170/105 mmHg were randomised to uRDN (n=74) or sham (n=72) in the RADIANCE-HTN SOLO trial. Initiation of AHM was encouraged for home BP >135/85 mmHg following primary endpoint ascertainment at 2 months. Patients and physicians were unblinded at 6 months. 

Results: Fifty-one of 74 patients (age: 53.9±11 years; 67% men) originally randomised to uRDN completed the 36-month follow-up. Initial screening OBP upon study entry was 145/92±14/10 mmHg on a mean of 1.2 AHM (range: 0-2.0). Baseline OBP after AHM washout was 154/99±13/8 mmHg. At 36 months, patients were on an average of 1.3 AHM (range: 0-3.0) with 8 patients on no AHM. OBP decreased by 18/11±15/9 mmHg from baseline to 36 months (p<0.001 for both). Overall, OBP control (<140/90 mmHg) improved from 29.4% at screening to 45.1% at 36 months (p=0.059). For patients uncontrolled at screening (n=36), systolic OBP decreased by 10.8 mmHg (p<0.001) at 36 months on similar AHM (p=0.158).

Conclusions: The safety and effectiveness of uRDN was durable to 36 months, with reduced OBP and improved OBP control despite a similar starting medication burden. No new uRDN-related long-term safety concerns were identified.

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clinical researchclinical trialsrenal sympathetic denervation
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