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

Rader F, Kirtane AJ, Wang Y, Daemen J, Lurz P, Sayer J, Saxena M, Levy T, Scicli AP, Thackeray L, Azizi M, Weber MA, Basile J, Bloch MJ, Lobo MD, Mahfoud F, Schmieder R, Sharp AS, McClure CK, Chertow G, Kahan T, Dauerman H, Ullery S (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 18

Pages Range: E677-E685

Journal Issue: 8

DOI: 10.4244/EIJ-D-22-00305

Abstract

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.

Authors with CRIS profile

Involved external institutions

Cedars-Sinai Medical Center United States (USA) (US) Columbia University Irving Medical Center (CUIMC) United States (USA) (US) Abbott Northwestern Hospital United States (USA) (US) Erasmus University Medical Center (MC) Netherlands (NL) Universität Leipzig Germany (DE) Essex Cardiothoracic Centre United Kingdom (GB) Queen Mary, University of London United Kingdom (GB) Royal Bournemouth Hospital United Kingdom (GB) North American Science Associates (NAMSA) United States (USA) (US) Université Paris-Sud France (FR) SUNY Downstate Medical Center United States (USA) (US) Medical University of South Carolina (MUSC) United States (USA) (US) University of Nevada, Reno United States (USA) (US) St Bartholomew's Hospital United Kingdom (GB) Universitätsklinikum des Saarlandes (UKS) Germany (DE) University Hospital of Wales (UHW) United Kingdom (GB) Stanford University United States (USA) (US) Karolinska Institute Sweden (SE) University of Vermont United States (USA) (US)

How to cite

APA:

Rader, F., Kirtane, A.J., Wang, Y., Daemen, J., Lurz, P., Sayer, J.,... Ullery, S. (2022). Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial. EuroIntervention, 18(8), E677-E685. https://dx.doi.org/10.4244/EIJ-D-22-00305

MLA:

Rader, Florian, et al. "Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial." EuroIntervention 18.8 (2022): E677-E685.

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