Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials
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Published:2023-05-01
Issue:5
Volume:8
Page:464
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ISSN:2380-6583
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Container-title:JAMA Cardiology
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language:en
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Short-container-title:JAMA Cardiol
Author:
Kirtane Ajay J.12, Sharp Andrew S. P.3, Mahfoud Felix45, Fisher Naomi D. L.6, Schmieder Roland E.7, Daemen Joost8, Lobo Melvin D.9, Lurz Philipp10, Basile Jan11, Bloch Michael J.12, Weber Michael A.13, Saxena Manish9, Wang Yale14, Sanghvi Kintur15, Jenkins J. Stephen16, Devireddy Chandan17, Rader Florian18, Gosse Philippe19, Sapoval Marc202122, Barman Neil C.23, Claude Lisa23, Augustin Dimitri23, Thackeray Lisa24, Mullin Christopher M.24, Azizi Michel202122, McClure Candace K.25, Chertow Glenn25, Chandra Venita25, Dauerman Harold25, Kahan Thomas25, Ullery Steven25, Beohar Nirat25, Dogan Ozgen25, Mokrzycki Michelle25, Mullaney Scott25, Redfors Bjorn25, Vefali Huseng25, Abbott J. Dawn25, Loening Andreas25, Zagoria Ron25, Skeik Nedaa25, Bae Richard25, McMeans Amy25, Goldman JoAnne25, Peterson Rose25, Jay Desmond25, Schwartz Robert25, Reilly John25, Cash Micheal25, Tutor Isabelle25, Harrison Michael25, Williams Shannon Williams25, Jarvis Maria25, Penning Angel25, Lea Janice25, Fiebach Amanda25, Merlin Claudia25, Wells Bryan25, Dohad Suhail25, Tran Anne25, Bhatia Kirin25, Kim Hyun-Min25, Rashid Mohammad25, Victor Ronald25, Sobieszczyk Piotr25, Halliday Ian25, Munson Tay25, Mauri Laura25, Smith Alex25, Aseltine Laura25, Williams Jonathan25, Lindsey Jason25, Laster Steven25, Bunte Mathew25, Hart Anthony25, King Dana25, Hall Jamie25, Costello Josh25, Krathen Courtney25, Lewis Luot25, McElvarr Andrew25, Willitts Ashley25, Todoran Thomas25, Powers Eric25, Palmer Casey25, Hodskins Emily25, Paladugu Vijay25, Tecklenburg Anna25, Schindler John25, Pacella John25, Muldoon Matthew25, Albright MaryJo25, Nicholson Tracy25, Flack John25, Chami Youseff25, Hafiz Abdul Moiz25, Starkey Emily25, Adams Kristal25, Bernardo Nelson25, Veis Judith25, Hashim Hayder25, Singh Suman25, Whitman Donna25, Stouffer Rick25, Hinderliter Alan25, Allen Meghan25, Scholl Tatum25, Pauley Eric25, Wade Tyrone25, Fong Pete25, Laffer Chery25, Gainer James25, Robbins Mark25, Crook Sherron25, Hatchcock Ellen25, Maddel Sarita25, Cohen Debbie25, Giri Jay25, Kobayashi Taisei25, Neubauer Robin25, Naidu Suveeksha25, Vo Thu25, Radhakrishnan Jai25, Batres Candido25, Edwards Suzanne25, Khuddus Matheen25, Zentko Suzanne25, Touchton Abby25, Roberson Marti25, O'Meara James25, Barb Ilie25, Foster Abby25, Boyette Alice25, Akinapelli Abhilash25, English Lisa25, Neumann Bridget25, Roongsritong Chanwit25, Nelson Priscilla25, Mendelsohn Farrel25, Brantley Hutton25, Cawthon Thomas25, DeRamus Susan25, Wade Wesley25, Fishman Robert25, Tuohy Edward25, LeBlanc Jessica25, McCurry Tina25, Krishnaswamy Amar25, Laffin Luke25, Bajzer Christopher25, Boros Marilyn25, Branche Monica25, Abraham Josephine25, Abraham Anu25, Stijleman Inge25, Lavasani Iran25, Neilson Hailey25, Owan Theophilus25, Hsi David25, Martin Scott25, Portnay Edward25, Ducey Maryanne25, Fiebach Maryann25, Rose Suzanne25, DelMasro Elizabeth25, Garavito Carolina25, Adams Todd25, Teklinski Andrew25, Leech Adam25, Drilling Patrick25, Tulik Lynda25, Benzuly Keith25, Paparello James25, Fintel Dan25, Ramirez Haydee25, Kats Lauren25, Huang Paul25, Biswas Santanu25, Risher Serena25, Pratt Kristina25, Ibebuogu Uzoma25, Johnson Karen25, Cushman William25, Jones Lisa25, Jackson Leigh25, Landers David25, Pasala Tilak25, Salazer Thomas25, Canino Peter25, Arakelian Patricia25, Yang Yi-Ming25, Khaliq Asma25, Weinberg Mitchell25, Abetu Yihenew25, Gulliver Alana25, Garasic Joseph25, Drachman Doug25, Zusman Randy25, Rosenfield Keneth25, Do Danny25, Chugh Atul25, Bertolet Barry25, Go Brian25, Gallapudi Raghava25, Cohn Joel25, Rogers Kevin25, Bangalore Sripal25, Williams Stephan25, Cabos Stanley25, Rodriguez Alvarez Carolina25, Calhoun David25, McElderry Thomas25, Maddox William25, Oparil Suzanne25, Kinder Sheila25, Goldman Jessie25, Ledley Gary25, Katof Nancy25, Aggarwal Sandeep25, Potluri Sriivasa25, Biedermann Scott25, Ward Jacquelyn25, White Megan25, Zidar David25, Shishehbor Mehdi25, Effron Barry25, Costa Marco25, Semenec Terence25, Huang Pei-Hsiu25, Jose Powell25, Jones Micheal25, Mathur Anthony25, Jain Ajay25, Balawon Armida25, Zongo Oliver25, Topham Christine25, Anderson Richard25, Thompson Elizabeth25, Spiro Nikki25, Hodges Elizabeth25, Holder Jaqueine25, D'Souza Richard J.25, Statton Sarah25, Wilkes Lindsay25, Joseph Anil25, Ellam Timothy25, Bagnall Alan25, Jackson Ralph25, Bridgett Victoria25, Wilson Peter25, Das Neelanjan25, Doulton Timothy25, Loader David25, Hector Gemma25, Levy Terry25, Bent Clare25, Kodoth Vivek25, Horler Stephanie25, Nix Sara25, Beckett David25, Lakeman Nicki25, Kennard Sarah25, Patel Amit25, Robinson Nicholas25, Al-Janabi Faris25, Sayer Jeremy25, Iyer Sudha Ganesh25, Redman Emily25, Ramirez Jonaifah25, Sevillano Annaliza25, Ocampo Madelaine25, Ali Edroos Sadat25, Padmanabhan Sandosh25, Gerber Robert25, Faris Mohamad25, Marshall Andrew John25, Sinclair Janet25, Pepper Hayley25, Elorz Cristina25, David Justin25, Chapman Neil25, Burak Paula25, Carvelli Paula25, Shun Shin Matthew25, Howard James25, Jadhav Sachin25, Quinn Jane25, Sharif Faisal25, Alhmoudi Aishah25, Lunardi Mattia25, Coen Eileen25, Glynn Nicola25, Böhm Michael25, Lauder Lucas25, Kulenthiran Saarraaken25, Koch Christina25, Wachter Angelika25, Ewen Sebastian25, Lucic Jelena25, Schmid Axel25, Kannenkeril Dennis25, Ott Christian25, Uder Michael25, Heinritz Ulrike25, Fröhlich-Endres Kerstin25, Rommel Karl -Philipp25, Fengler Karl 25, Höllriegel Robert25, Petzold Martin25, Büttner Margit25, Trautmann Kai25, Weil Joachim25, Agdirlioglu Tolga25, Köllner Tanja25, Stephan Jeannine25, Hafer Lukas25, Dagkonakis Nikolaos25, Hamann Frank25, Reimer Peter25, Hausberg Martin25, Ettl Ute25, Petzsche Ulrike25, Hinrichs Ralf25, Di Ponio-Voit Isabella25, Lutz Matthias25, Rump Lars Christian25, Stegbauer Johannes25, Schimmöller Lars25, Potthoff Sebastian25, Schmid Claudia25, Roeder Sylvia25, Kröpil Patric25, Genth-Zotz Sabine25, Kämpfner Denise25, Grawe Armin25, Höhne Johannes25, Kaesberger Bärbel25, von zur Mühlen Constantin25, Wolf Dennis25, Welzel Markus25, Heinrichs Gudrun25, Trabitzsch Barbara25, Cremer Antoine25, Papadopoulos Panteleimon25, Gaudissard Julie25, Maire Florent25, Trillaud Hervé25, Livrozet Marine25, Regrag Asma25, Paquet Valerie25, Cornu Erika25, Fouassier David25, Lorthioir Aurélien25, Delsart Pascal25, Hennicaux Justin25, Longere Benjamin25, Bailly-Sommeville Coralie25, Bertrand Fabien25, Ledieu Guillaume25, Pontana François25, Pathak Atul25, Honton Benjamin25, Cottin Marianne25, Petit Frédéric25, Lantelme Pierr25, Berge Constance25, Courand Pierre-Yves25, Langevin Fatou25, Lafeber Melvin25, Zeijen Victor25, Ruiter Arno25, Huijskens Elisabeth25, Feyz Lida25, van Ramshorst Jan25, Blankestijn Peter25, Voskuil Michiel25, Rittersma Zwaantina25, Dolmans Helma25, Kroon A.A.25, van Zwam W.H.25, Vranken Jeannique25, de Haan Claudia25, Xaplanteris Panagiotis25, Briki Rachid25, de Hemptinne Quentin25, Pascal Severine25, Renard Katty25, Lefebvre Pascal25, Ferdinande Bert25, Persu Alexandre25, Renkin Jean25, Maes Frédéric25, Beauloye Christophe25, Lengelé Jean-Philippe25, Huyberechts Dominique25, Bouvier Anne25, Iglesias Juan F.25, Ehret Georg25, Gallego Laetitia25, Dobretz Kevin25, Bottone Sylviane25, Witkowski Adam25, Januszewicz Andrzej25, Kądziela Jacek Kądziela25, Prejbisj Aleksander25, Hering Dagmara25, Ciecwierz Dariusz25, Jaguszewski Milosz J.25, Owczuk Radoslaw25,
Affiliation:
1. Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York 2. Associate Editor, JAMA Cardiology 3. University Hospital of Wales and Cardiff University, Cardiff, United Kingdom 4. Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany 5. Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge 6. The Brigham and Women’s Hospital, Boston, Massachusetts 7. Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany 8. Department of Cardiology, University Medical Center Rotterdam, Rotterdam, the Netherlands 9. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom 10. Heart Center Leipzig, University of Leipzig, Leipzig, Germany 11. Division of Cardiovascular Medicine, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston 12. Vascular Care, Renown Institute of Heart and Vascular Health, Department of Medicine, University of Nevada School of Medicine, Reno 13. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York 14. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota 15. Deborah Heart & Lung Center, Brown Mills, New Jersey 16. Ochsner Medical Center, New Orleans, Louisiana 17. Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia 18. Cedars-Sinai Heart Institute, Los Angeles, California 19. Hôpital Saint-André–CHU, Bordeaux, France 20. Université Paris Cité, Paris, France 21. AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France 22. INSERM, CIC1418, Paris, France 23. ReCor Medical Inc, Palo Alto, California 24. NAMSA, Minneapolis, Minnesota 25. for the RADIANCE Investigators and Collaborators
Abstract
ImportanceUltrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.ObjectiveTo characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.Data SourcesA Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials.Study SelectionTrials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up.Data Extraction and SynthesisPooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials.Main Outcomes and MeasuresThe primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups.ResultsA total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, −5.9; 95% CI, −8.1 to −3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: −10.4 mm Hg vs −3.4 mm Hg; mean difference, −6.4 mm Hg; 95% CI, −9.1 to –3.6 mm Hg; home SBP: −8.4 mm Hg vs −1.4 mm Hg; mean difference, −6.8 mm Hg; 95% CI, −8.7 to −4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups.Conclusions and RelevanceResults of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.Trial RegistrationClinicalTrials.gov Identifier: NCT02649426 and NCT03614260
Publisher
American Medical Association (AMA)
Subject
Cardiology and Cardiovascular Medicine
Reference28 articles.
1. Trends in blood pressure control among US adults with hypertension, 1999-2000 to 2017-2018.;Muntner;JAMA,2020 2. What we know and don’t know about renal denervation to lower blood pressure.;Chau;JAMA Cardiol,2022 3. A controlled trial of renal denervation for resistant hypertension.;Bhatt;N Engl J Med,2014 4. Optimum and stepped care andomizedd antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, andomized controlled trial.;Azizi;Lancet,2015 5. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, andomized, sham-controlled trial.;Azizi;Lancet,2018
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