1. 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
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Constance Berge, Matthew Shun Shin, Michiel Voskuil, Florian Rader, Scott Biedermann, Robert Höllriegel, Antoine Cremer, Karl Philipp Rommel, A. A. Kroon, Erika Cornu, David Beckett, Janice P. Lea, Chanwit Roongsritong, Jean Renkin, Richard D'Souza, Justin E. Davies, Mark Robbins, Suzanne Zentko, Yale Wang, Marco A. Costa, Axel Schmid, Barry Effron, Sebastian Ewen, William Maddox, Ronald G. Victor, Peter J. Blankestijn, Cristina Elorz, Candace K. McClure, Sandeep Aggarwal, David Fouassier, Jonathan S. Williams, Felix Mahfoud, Mohamad Faris, Jelena Lucic, Piotr Sobieszczky, Thomas M. Todoran, Suhail Dohad, David His, Chandan Devireddy, Pei Hsiu Huang, Marc Sapoval, Robert S. Schwartz, Alexandre Persu, Anthony Mathur, Jessie Goldman, Scott Martin, Josephine Abraham, Josh Costello, Michael Böhm, Thomas McElderry, Melvin D. Lobo, Christian Ott, Matheen Khuddus, Helen Reeve-Stoffer, Michael Cash, Philippe Gosse, Sripal Bangalore, Andrew S.P. Sharp, Michael J. Bloch, Eric R. Powers, Hervé Trillaud, Andrew John Marshall, Christian Rump, Jan Basile, Nedaa Skeik, Randy Zusman, Atul Pathak, James V. Gainer, Kenneth Rosenfield, Bryan Wells, Doug Drachman, Clare Bent, Karl Fengler, Neil C. Barman, Alan L. Hinderliter, Stephen Williams, Emily Hodskins, Terry Levy, Ajay J. Kirtane, Michael Uder, Courtney Walsh, David A. Calhoun, Amit R. Patel, James O'Meara, Sudha Ganesh Iyer, Joseph M. Garasic, Panteleimon Papadopoulos, Michael A. Weber, Suzanne Oparil, Joost Daemen, Philipp Lurz, Edward Portnay, Cheryl L. Laffer, W. H. Van Zwam, Mehdi H. Shishehbor, Pete Fong, Eric Pauley, Rick Stouffer, Johannes Stegbauer, Jeremy Sayer, Ilie Barb, Pierre Lantelme, Lida Feyz, Ajay Jain, Desmond Jay, Roland E. Schmieder, Jai Radhakrishnan, Michel Azizi, Anu Abraham, Zwaantina Rittersma, Nicholas M Robinson, John P. Reilly, Gary Ledley, Theophilus Owan, Powell Jose, David A. Zidar, Manish Saxena, Sadat Ali Edroos, Pierre-Yves Courand, James P. Howard, Aurélien Lorthioir, Robert Gerber, Anil Joseph, Neil Chapman, Benjamin Honton, Patric Kröpil, Laura Mauri, Srinivasa Potluri, Naomi D.L. Fisher, Kintur Sanghvi, CIC - HEGP (CIC 1418), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Cardiology, and Gastroenterology & Hepatology
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Randomization ,ablation, catheter ,hypertension ,[SDV]Life Sciences [q-bio] ,030204 cardiovascular system & hematology ,ablation ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,hypertension, renal ,law ,Physiology (medical) ,placebos ,Journal Article ,Medicine ,030212 general & internal medicine ,ComputingMilieux_MISCELLANEOUS ,Denervation ,Hypertension control ,denervation ,business.industry ,Ultrasound ,renal, placebos, randomized controlled trial ,catheter ,3. Good health ,Anesthesia ,randomized controlled trial ,renal ,catheter, denervation, hypertension ,business ,Cardiology and Cardiovascular Medicine - Abstract
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 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.
- Published
- 2019
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