1. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial
- Author
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Michel Azizi, Roland E Schmieder, Felix Mahfoud, Michael A Weber, Joost Daemen, Justin Davies, Jan Basile, Ajay J Kirtane, Yale Wang, Melvin D Lobo, Manish Saxena, Lida Feyz, Florian Rader, Philipp Lurz, Jeremy Sayer, Marc Sapoval, Terry Levy, Kintur Sanghvi, Josephine Abraham, Andrew S P Sharp, Naomi D L Fisher, Michael J Bloch, Helen Reeve-Stoffer, Leslie Coleman, Christopher Mullin, Laura Mauri, Desmond Jay, Nedaa Skeik, Robert Schwartz, Suhail Dohad, Ronald Victor, Josh Costello, Courtney Walsh, Theophilus Owan, Anu Abraham, Naomi D.L. Fisher, Piotr Sobieszczky, Jonathan Williams, Michael J. Bloch, Chanwit Roongsritong, Thomas Todoran, Eric Powers, Emily Hodskins, Pete Fong, Cheryl Laffer, James Gainer, Mark Robbins, John P. Reilly, Michael Cash, Jessie Goldman, Sandeep Aggarwal, Gary Ledley, David Hsi, 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, Ajay J. Kirtane, Jai Radhakrishnan, Melvin D. Lobo, Anthony Mathur, Ajay Jain, Sudha Ganesh Iyer, Nicholas Robinson, Sadat Ali Edroos, Amit Patel, David Beckett, Clare Bent, Neil Chapman, Matthew Shun-Shin, James Howard, Andrew S.P. Sharp, Anil Joseph, Richard D'Souza, Robert Gerber, Mohamad Faris, Andrew J. Marshall, Cristina Elorz, Robert Höllriegel, Karl Fengler, Karl-Philipp Rommel, Michael Böhm, Sebastian Ewen, Jelena Lucic, Roland E. Schmieder, Christian Ott, Axel Schmid, Michael Uder, L. Christian Rump, Johannes Stegbauer, Patric Kröpil, Erika Cornu, David Fouassier, Philippe Gosse, Antoine Cremer, Hervé Trillaud, Panteleimon Papadopoulos, Atul Pathak, Benjamin Honton, Pierre Lantelme, Constance Berge, Pierre-Yves Courand, Peter J. Blankestijn, Michiel Voskuil, Zwaantina Rittersma, A.A. Kroon, W.H. van Zwam, Alexandre Persu, Jean Renkin, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Cardiology
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Adult ,Male ,Ambulatory blood pressure ,Adolescent ,[SDV]Life Sciences [q-bio] ,Population ,030204 cardiovascular system & hematology ,Renal artery stenosis ,Kidney ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Renal Artery ,medicine.artery ,medicine ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Kidney surgery ,Renal artery ,education ,ComputingMilieux_MISCELLANEOUS ,Aged ,Ultrasonography ,Denervation ,education.field_of_study ,business.industry ,Endovascular Procedures ,General Medicine ,Blood Pressure Monitoring, Ambulatory ,Middle Aged ,medicine.disease ,3. Good health ,Blood pressure ,Treatment Outcome ,Editorial ,Anesthesia ,Ambulatory ,Hypertension ,Female ,business - Abstract
Summary Background Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. Methods RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic–diastolic hypertension aged 18–75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Findings Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (−8·5 mm Hg, SD 9·3) than with the sham procedure (−2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: −6·3 mm Hg, 95% CI −9·4 to −3·1, p=0·0001). No major adverse events were reported in either group. Interpretation Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Funding ReCor Medical.
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- 2018