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