Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial

Azizi M, Schmieder R, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, Mcclure C, Kirtane AJ (2019)

Publication Type: Journal article

Publication year: 2019

Journal

DOI: 10.1161/CIRCULATIONAHA.119.040451

Abstract

BACKGROUND: The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial demonstrated a 6.3 mmHg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results following the addition of a recommended standardized stepped-care antihypertensive treatment (SSAHT) to the randomized endovascular procedure under continued blinding to initial treatment. METHODS: Patients with a daytime ambulatory BP greater ≥135/85 mmHg and <170/105 mmHg after a 4-week discontinuation of up to 2 antihypertensive medications and a suitable renal artery anatomy, were randomized to RDN (n=74) or sham (n=72). Patients were to remain off antihypertensive medications throughout the first 2 months of follow-up unless safety BP criteria were exceeded. Between 2 and 5 months, if monthly measured home BP was ≥135/85 mmHg, a SSAHT was recommended consisting of the sequential addition of amlodipine 5 mg/day, a standard dose of an angiotensin converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide 12.5 mg/day, followed by the sequential uptitration of hydrochlorothiazide (25 mg/day) and amlodipine (10 mg/day). Outcomes included the 6-month (i) change in daytime ambulatory systolic BP adjusted for medications and baseline SBP, (ii) medication burden, and (iii) safety. RESULTS: A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the SSAHT vs. 84.5% in the sham group (p=0.008) and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 vs. 1.3±0.9, p=0.010 and 1.4±1.5 vs. 2.0±1.8, p=0.018; respectively). Despite less intensive SSAHT, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (-18.1±12.2 vs. -15.6±13.2 mmHg, respectively; difference adjusted for baseline BP and number of medications: -4.3 mmHg, 95% confidence interval, -7.9 to -0.6, p=0.024). There were no major adverse events in either group through 6 months. CONCLUSIONS: The BP lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02649426.

Authors with CRIS profile

Involved external institutions

University of Paris 5 - René Descartes / Université Paris V René Descartes France (FR) Universitätsklinikum des Saarlandes (UKS) Germany (DE) SUNY Downstate Medical Center United States (USA) (US) Erasmus University Medical Center (MC) Netherlands (NL) Queen Mary University of London United Kingdom (GB) Royal Devon & Exeter NHS Foundation Trust United Kingdom (GB) University of Nevada Las Vegas United States (USA) (US) Medical University of South Carolina (MUSC) United States (USA) (US) Abbott Northwestern Hospital United States (USA) (US) ReCor Medical Inc. United States (USA) (US) North American Science Associates (NAMSA) United States (USA) (US) Columbia University United States (USA) (US) Universität Leipzig Germany (DE) Cedars-Sinai Medical Center United States (USA) (US) Essex Cardiothoracic Centre United Kingdom (GB) Brigham and Women's Hospital (BWH) United States (USA) (US)

How to cite

APA:

Azizi, M., Schmieder, R., Mahfoud, F., Weber, M.A., Daemen, J., Lobo, M.D.,... Kirtane, A.J. (2019). Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. https://doi.org/10.1161/CIRCULATIONAHA.119.040451

MLA:

Azizi, Michel, et al. "Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial." Circulation (2019).

BibTeX: Download