Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial
Authors: Azizi Michel , Schmieder Roland E. , Mahfoud Felix , Weber Michael A. , Daemen Joost , Lobo Melvin D. , Sharp Andrew S.P. , Bloch Michael J. , Basile Jan , Wang Yale , Saxena Manish , Lurz Philipp , Rader Florian , Sayer Jeremy , Fisher Naomi D.L. , Fouassier David , Barman Neil C. , Reeve-Stoffer Helen , McClure Candace , Kirtane Ajay J. ,   On behalf of the RADIANCE-HTN Investigators, Jay Desmond , Skeik Nedaa , Schwartz Robert , Dohad Suhail , Victor Ronald , Sanghvi Kintur , Costello Josh , Walsh Courtney , Abraham Josephine , Owan Theophilus , Abraham Anu , Mauri Laura , Sobieszczky Piotr , Williams Jonathan , Roongsritong Chanwit , Todoran Thomas , Powers Eric , Hodskins Emily , Fong Pete , Laffer Cheryl , Gainer James , Robbins Mark , Reilly John , Cash Michael , Goldman Jessie , Aggarwal Sandeep , Ledley Gary , His David , Martin Scott , Portnay Edward , Calhoun David , McElderry Thomas , Maddox William , Oparil Suzanne , Huang Pei-Hsiu , Jose Powell , Khuddus Matheen , Zentko Suzanne , O’Meara James , Barb Ilie , Garasic Joseph , Drachman Doug , Zusman Randy , Rosenfield Kenneth , Devireddy Chandan , Lea Janice , Wells Bryan , Stouffer Rick , Hinderliter Alan , Pauley Eric , Potluri Srinivasa , Biedermann Scott , Bangalore Sripal , Williams Stephen , Zidar David , Shishehbor Mehdi , Effron Barry , Costa Marco , Radhakrishnan Jai , Mathur Anthony , Jain Ajay , Iyer Sudha Ganesh , Robinson Nicholas , Edroos Sadat Ali , Levy Terry , Patel Amit , Beckett David , Bent Clare , Davies Justin , Chapman Neil , Shin Matthew Shun , Howard James , Joseph Anil , D’Souza Richard , Gerber Robert , Faris Mohamad , Marshall Andrew John , Elorz Cristina , Höllriegel Robert , Fengler Karl , Rommel Karl-Philipp , Böhm Michael , Ewen Sebastian , Lucic Jelena , Ott Christian , Schmid Axel , Uder Michael , Rump Christian , Stegbauer Johannes , Kröpil Patric , Sapoval Marc , Cornu Erika , Lorthioir Aurélien , Gosse Philippe , Cremer Antoine , Trillaud Hervé , Papadopoulos Panteleimon , Pathak Atul , Honton Benjamin , Lantelme Pierre , Berge Constance , Courand Pierre-Yves , Feyz Lida , Blankestijn Peter , Voskuil Michiel , Rittersma Zwaantina , Kroon A.A. , van Zwam W.H. , Persu Alexandre , Renkin Jean 
Published: March 2019

Background:
The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg 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 after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment.

Methods:
Patients with a daytime ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg 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 mm Hg, a standardized stepped-care antihypertensive treatment was recommended consisting of the sequential addition of amlodipine (5 mg/d), a standard dose of an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide (12.5 mg/d), followed by the sequential uptitration of hydrochlorothiazide (25 mg/d) and amlodipine (10 mg/d). Outcomes included the 6-month (1) change in daytime ambulatory systolic BP adjusted for medications and baseline systolic BP, (2) medication burden, and (3) 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 standardized stepped-care antihypertensive treatment versus 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 versus 1.3±0.9,
P
=0.010 and 1.4±1.5 versus 2.0±1.8,
P
=0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (−18.1±12.2 versus −15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: −4.3 mm Hg, 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.