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Circulation. 2019 Mar 17. doi: 10.1161/CIRCULATIONAHA.119.040451. [Epub ahead of print]

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.

Author information

1
Université Paris-Descartes, Paris, France & AP-HP, H#x00F4;pital Européen Georges-Pompidou, Hypertension Department, Paris, France.
2
Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.
3
Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany & Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA.
4
Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, NY.
5
Erasmus MC, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, NL, The Netherlands.
6
Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK.
7
Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
8
Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, NV.
9
Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston, SC.
10
Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN.
11
Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
12
Cedars-Sinai Heart Institute, Los Angeles, CA.
13
The Essex Cardiothoracic Centre, Essex, UK.
14
The Brigham and Women's Hospital, Boston, MA.
15
ReCor Medical, Inc., Palo Alto, CA.
16
NAMSA, Minneapolis, MN.
17
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY.

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.

KEYWORDS:

denervation; hypertension therapy; sham

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