Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

doi:10.1001/jama.2023.0713

Randomized Controlled Trial

. 2023 Feb 28;329(8):651-661.

doi: 10.1001/jama.2023.0713.

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Michel Azizi^{1

2

3}, Manish Saxena⁴, Yale Wang⁵, J Stephen Jenkins⁶, Chandan Devireddy⁷, Florian Rader⁸, Naomi D L Fisher⁹, Roland E Schmieder¹⁰, Felix Mahfoud^{11

12}, Jason Lindsey¹³, Kintur Sanghvi¹⁴, Thomas M Todoran^{15

16}, John Pacella¹⁷, John Flack¹⁸, Joost Daemen¹⁹, Andrew S P Sharp^{20

21}, Philipp Lurz²², Michael J Bloch²³, Michael A Weber²⁴, Melvin D Lobo⁴, Jan Basile¹⁵, Lisa Claude²⁵, Helen Reeve-Stoffer²⁵, Candace K McClure²⁶, Ajay J Kirtane²⁷; RADIANCE II Investigators and Collaborators

Collaborators, Affiliations

Collaborators

RADIANCE II Investigators and Collaborators:
Christopher Mullin, Candace K McClure, Lisa Thackeray, Yongshi Wang, Glenn Chertow, Venita Chandra, Harold Dauerman, Thomas Kahan, Steven Ullery, Nirat Beohar, Ozgen Dogan, Michelle Mokrzycki, Scott Mullaney, Bjorn Redfors, Huseng Vefali, Andreas Loening, Ron Zagoria, Nedaa Skeik, Richard Bae, Amy McMeans, JoAnne Goldman, Rose Peterson, Isabelle Tutor, Michael Harrison, Angel Penning, Janice Lea, Amanda Fiebach, Claudia Merlin, Suhail Dohad, Anne Tran, Kirin Bhatia, Piotr Sobieszczyk, Ian Halliday, Tay Munson, Steven Laster, Mathew Bunte, Anthony Hart, Dana King, Jamie Hall, Courtney Krathen, Luot Lewis, Ashley Willitts, Anthony Awkar, Casey Palmer, Anna Tecklenburg, John Schindler, Matthew Muldoon, MaryJo Albright, Tracy Nicholson, Youseff Chami, Abdul Moiz Hafiz, Emily Starkey, Kristal Adams, Nelson Bernardo, Judith Veis, Hayder Hashim, Suman Singh, Donna Whitman, Rick Stouffer, Alan Hinderliter, Meghan Allen, Tatum Scholl, Pete Fong, James Gainer, Sherron Crook, Ellen Hatchcock, Debbie Cohen, Jay Giri, Taisei Kobayashi, Robin Neubauer, Suveeksha Naidu, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Matheen Khuddus, Suzanne Zentko, Abby Touchton, Marti Roberson, Abhilash Akinapelli, Lisa English, Bridget Neumann, Farrel Mendelsohn, Hutton Brantley, Thomas Cawthon, Susan DeRamus, Wesley Wade, Robert Fishman, Edward Tuohy, Jessica LeBlanc, Tina McCurry, Amar Krishnaswamy, Luke Laffin, Christopher Bajzer, Marilyn Boros, Monica Branche, Josephine Abraham, Anu Abraham, Inge Stijleman, David Hsi, Scott Martin, Edward Portnay, Maryann Fiebach, Carolina Garavito, Todd Adams, Andrew Teklinski, Adam Leech, Patrick Drilling, Lynda Tulik, Keith Benzuly, James Paparello, Dan Fintel, Haydee Ramirez, Lauren Kats, Paul Huang, Santanu Biswas, Serena Risher, Kristina Pratt, Uzoma Ibebuogu, Karen Johnson, William Cushman, Lisa Jones, Leigh Jackson, David Landers, Tilak Pasala, Thomas Salazer, Peter Canino, Patricia Arakelian, Yi-Ming Yang, Asma Khaliq, Mitchell Weinberg, Yihenew Abetu, Alana Gulliver, J P Reilly, Joseph Garasic, Atul Chugh, Barry Bertolet, Brian Go, Raghava Gollapudi, Joel Cohn, Kevin Rogers, Anthony Mathur, Ajay Jain, Armida Balawon, Oliver Zongo, Christine Topham, Richard Anderson, Elizabeth Thompson, Nikki Spiro, Elizabeth Hodges, Timothy Ellam, Alan Bagnall, Ralph Jackson, Victoria Bridgett, Peter Wilson, Neelanjan Das, Timothy Doulton, David Loader, Gemma Hector, Terry Levy, Clare Bent, Vivek Kodoth, Stephanie Horler, Sara Nix, Nicholas Robinson, Firas Al-Janabi, Jeremy Sayer, Sudha Ganesh Iyer, Emily Redman, Jonaifah Ramirez, Sandosh Padmanabhan, Faisal Sharif, Aishah Alhmoudi, Mattia Lunardi, Eileen Coen, Nicola Glynn, Lucas Lauder, Saarraaken Kulenthiran, Christina Koch, Angelika Wachter, Axel Schmid, Dennis Kannenkeril, Ulrike Heinritz, Kerstin Endres-Frohlich, Karl Philipp Rommel, Karl Fengler, Martin Petzold, Margit Büttner, Joachim Weil, Tolga Agdirlioglu, Tanja Köllner, Jeannine Stephan, Nikolaos Dagkonakis, Frank Hamann, Ute Ettl, Ulrike Petzsche, Peter Reimer, Martin Hausberg, Ralf Hinrichs, Isabella Di Ponio-Voit, Matthias Lutz, Philippe Gosse, Antoine Cremer, Panteleimon Papadopoulos, Julie Gaudissard, Florent Maire, Marc Sapoval, Marine Livrozet, Asma Regrag, Valerie Paquet, Pascal Delsart, Justin Hennicaux, Coralie Sommeville, Fabien Bertrand, Melvin Lafeber, Victor Zeijen, Amo Ruiter, Jan van Ramshorst, Panagiotis Xaplanteris, Rachid Briki, Quentin de Hemptinne, Severine Pascal, Katty Renard, Pascal Lefebvre, Bert Ferdinande, Juan F Iglesias, Georg Ehret, Laetitia Gallego, Kevin Dobretz

Affiliations

¹ Université Paris Cité, Paris, France.
² AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France.
³ INSERM, CIC1418, Paris, France.
⁴ Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, England.
⁵ Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota.
⁶ Ochsner Medical Center, New Orleans, Louisiana.
⁷ Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
⁸ Cedars-Sinai Heart Institute, Los Angeles, California.
⁹ Brigham and Women's Hospital, Boston, Massachusetts.
¹⁰ Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.
¹¹ Klinik für Innere Medizin III, Saarland University Hospital, Homburg, Germany.
¹² Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge.
¹³ Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
¹⁴ Deborah Heart and Lung Center, Brown Mills, New Jersey.
¹⁵ Division of Cardiovascular Medicine, Medical University of South Carolina, Charleston.
¹⁶ Ralph H. Johnson VA Medical Center, Charleston, South Carolina.
¹⁷ University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
¹⁸ Springfield Memorial Hospital, Southern Illinois University School of Medicine, Springfield.
¹⁹ Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, the Netherlands.
²⁰ University Hospital of Wales, Cardiff, England.
²¹ University of Exeter, Exeter, England.
²² Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
²³ Vascular Care, Renown Institute of Heart and Vascular Health, Department of Medicine, University of Nevada School of Medicine, Reno.
²⁴ Downstate Medical Center, Division of Cardiovascular Medicine, State University of New York, New York.
²⁵ ReCor Medical, Inc, Palo Alto, California.
²⁶ NAMSA, Minneapolis, Minnesota.
²⁷ Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.

PMID: 36853250
PMCID: PMC9975904
DOI: 10.1001/jama.2023.0713

Randomized Controlled Trial

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Michel Azizi et al. JAMA. 2023.

. 2023 Feb 28;329(8):651-661.

doi: 10.1001/jama.2023.0713.

Authors

Collaborators

RADIANCE II Investigators and Collaborators:
Christopher Mullin, Candace K McClure, Lisa Thackeray, Yongshi Wang, Glenn Chertow, Venita Chandra, Harold Dauerman, Thomas Kahan, Steven Ullery, Nirat Beohar, Ozgen Dogan, Michelle Mokrzycki, Scott Mullaney, Bjorn Redfors, Huseng Vefali, Andreas Loening, Ron Zagoria, Nedaa Skeik, Richard Bae, Amy McMeans, JoAnne Goldman, Rose Peterson, Isabelle Tutor, Michael Harrison, Angel Penning, Janice Lea, Amanda Fiebach, Claudia Merlin, Suhail Dohad, Anne Tran, Kirin Bhatia, Piotr Sobieszczyk, Ian Halliday, Tay Munson, Steven Laster, Mathew Bunte, Anthony Hart, Dana King, Jamie Hall, Courtney Krathen, Luot Lewis, Ashley Willitts, Anthony Awkar, Casey Palmer, Anna Tecklenburg, John Schindler, Matthew Muldoon, MaryJo Albright, Tracy Nicholson, Youseff Chami, Abdul Moiz Hafiz, Emily Starkey, Kristal Adams, Nelson Bernardo, Judith Veis, Hayder Hashim, Suman Singh, Donna Whitman, Rick Stouffer, Alan Hinderliter, Meghan Allen, Tatum Scholl, Pete Fong, James Gainer, Sherron Crook, Ellen Hatchcock, Debbie Cohen, Jay Giri, Taisei Kobayashi, Robin Neubauer, Suveeksha Naidu, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Matheen Khuddus, Suzanne Zentko, Abby Touchton, Marti Roberson, Abhilash Akinapelli, Lisa English, Bridget Neumann, Farrel Mendelsohn, Hutton Brantley, Thomas Cawthon, Susan DeRamus, Wesley Wade, Robert Fishman, Edward Tuohy, Jessica LeBlanc, Tina McCurry, Amar Krishnaswamy, Luke Laffin, Christopher Bajzer, Marilyn Boros, Monica Branche, Josephine Abraham, Anu Abraham, Inge Stijleman, David Hsi, Scott Martin, Edward Portnay, Maryann Fiebach, Carolina Garavito, Todd Adams, Andrew Teklinski, Adam Leech, Patrick Drilling, Lynda Tulik, Keith Benzuly, James Paparello, Dan Fintel, Haydee Ramirez, Lauren Kats, Paul Huang, Santanu Biswas, Serena Risher, Kristina Pratt, Uzoma Ibebuogu, Karen Johnson, William Cushman, Lisa Jones, Leigh Jackson, David Landers, Tilak Pasala, Thomas Salazer, Peter Canino, Patricia Arakelian, Yi-Ming Yang, Asma Khaliq, Mitchell Weinberg, Yihenew Abetu, Alana Gulliver, J P Reilly, Joseph Garasic, Atul Chugh, Barry Bertolet, Brian Go, Raghava Gollapudi, Joel Cohn, Kevin Rogers, Anthony Mathur, Ajay Jain, Armida Balawon, Oliver Zongo, Christine Topham, Richard Anderson, Elizabeth Thompson, Nikki Spiro, Elizabeth Hodges, Timothy Ellam, Alan Bagnall, Ralph Jackson, Victoria Bridgett, Peter Wilson, Neelanjan Das, Timothy Doulton, David Loader, Gemma Hector, Terry Levy, Clare Bent, Vivek Kodoth, Stephanie Horler, Sara Nix, Nicholas Robinson, Firas Al-Janabi, Jeremy Sayer, Sudha Ganesh Iyer, Emily Redman, Jonaifah Ramirez, Sandosh Padmanabhan, Faisal Sharif, Aishah Alhmoudi, Mattia Lunardi, Eileen Coen, Nicola Glynn, Lucas Lauder, Saarraaken Kulenthiran, Christina Koch, Angelika Wachter, Axel Schmid, Dennis Kannenkeril, Ulrike Heinritz, Kerstin Endres-Frohlich, Karl Philipp Rommel, Karl Fengler, Martin Petzold, Margit Büttner, Joachim Weil, Tolga Agdirlioglu, Tanja Köllner, Jeannine Stephan, Nikolaos Dagkonakis, Frank Hamann, Ute Ettl, Ulrike Petzsche, Peter Reimer, Martin Hausberg, Ralf Hinrichs, Isabella Di Ponio-Voit, Matthias Lutz, Philippe Gosse, Antoine Cremer, Panteleimon Papadopoulos, Julie Gaudissard, Florent Maire, Marc Sapoval, Marine Livrozet, Asma Regrag, Valerie Paquet, Pascal Delsart, Justin Hennicaux, Coralie Sommeville, Fabien Bertrand, Melvin Lafeber, Victor Zeijen, Amo Ruiter, Jan van Ramshorst, Panagiotis Xaplanteris, Rachid Briki, Quentin de Hemptinne, Severine Pascal, Katty Renard, Pascal Lefebvre, Bert Ferdinande, Juan F Iglesias, Georg Ehret, Laetitia Gallego, Kevin Dobretz

Affiliations

¹ Université Paris Cité, Paris, France.
² AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France.
³ INSERM, CIC1418, Paris, France.
⁴ Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, England.
⁵ Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota.
⁶ Ochsner Medical Center, New Orleans, Louisiana.
⁷ Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
⁸ Cedars-Sinai Heart Institute, Los Angeles, California.
⁹ Brigham and Women's Hospital, Boston, Massachusetts.
¹⁰ Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.
¹¹ Klinik für Innere Medizin III, Saarland University Hospital, Homburg, Germany.
¹² Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge.
¹³ Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
¹⁴ Deborah Heart and Lung Center, Brown Mills, New Jersey.
¹⁵ Division of Cardiovascular Medicine, Medical University of South Carolina, Charleston.
¹⁶ Ralph H. Johnson VA Medical Center, Charleston, South Carolina.
¹⁷ University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
¹⁸ Springfield Memorial Hospital, Southern Illinois University School of Medicine, Springfield.
¹⁹ Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, the Netherlands.
²⁰ University Hospital of Wales, Cardiff, England.
²¹ University of Exeter, Exeter, England.
²² Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
²³ Vascular Care, Renown Institute of Heart and Vascular Health, Department of Medicine, University of Nevada School of Medicine, Reno.
²⁴ Downstate Medical Center, Division of Cardiovascular Medicine, State University of New York, New York.
²⁵ ReCor Medical, Inc, Palo Alto, California.
²⁶ NAMSA, Minneapolis, Minnesota.
²⁷ Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.

PMID: 36853250
PMCID: PMC9975904
DOI: 10.1001/jama.2023.0713

Erratum in

Two Incorrect Names.
[No authors listed] [No authors listed] JAMA. 2023 Jun 13;329(22):1989. doi: 10.1001/jama.2023.8136. JAMA. 2023. PMID: 37314287 Free PMC article. No abstract available.

Abstract

Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment.

Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension.

Design, setting, and participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms.

Interventions: Ultrasound renal denervation vs a sham procedure.

Main outcomes and measures: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months.

Results: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group.

Conclusions and relevance: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events.

Trial registration: ClinicalTrials.gov Identifier: NCT03614260.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Azizi reported receiving grants from the European Horizon 2020 program; receiving grants and nonfinancial support from ReCor Medical and Idorsia; and receiving personal fees from Alnylam Pharmaceuticals, Poxel SA, Medtronic, and Novartis. Dr Saxena reported receiving grants from ReCor Medical, Ablative Solutions, Applied Therapeutics, Vascular Dynamics, and Merck Sharp and Dohme and receiving consulting fees from ReCor Medical, Esperion Therapeutics, Daiichi Sankyo, Novartis, and Vifor Pharma. Dr Jenkins reported institutional funding given to the Ochsner Medical Center from Medtronic, Abbott, Abiomed, and ReCor Medical and receiving personal fees for speaking engagements, proctoring, or consulting from Abbott, ReCor Medical, and Medtronic. Dr Devireddy reported receiving personal fees from ReCor Medical, Medtronic, Edwards Lifesciences, and Shockwave Medical. Dr Rader reported receiving personal fees from ReCor Medical, Medtronic, and Bristol Myers Squibb. Dr Fisher reported receiving grants and personal fees from ReCor Medical and receiving personal fees from Medtronic. Dr Schmieder reported receiving grants and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. Dr Mahfoud reported receiving grants from Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft, and Deutsche Herzstiftung and receiving personal fees from ReCor Medical, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, Servier, and Terumo. Dr Sanghvi reported receiving grants and personal fees from ReCor Medical and Medtronic and receiving grants from Cardiovascular Systems Inc. Dr Todoran reported receiving personal fees from ReCor Medical. Dr Flack reported receiving grants from GSK (formerly GlaxoSmithKline), Vascular Dynamics, Quantum Genomics, Idorsia, Janssen, and ReCor Medical and receiving personal fees from GSK, Amgen, Janssen, Teva Pharmaceuticals, and FibroGen. Dr Daemen reported receiving grants from ReCor Medical, Medtronic, Boston Scientific, Abbott Vascular, ACIST Medical Systems, AstraZeneca, MicroPort, Pie Medical Imaging, and PulseCath and receiving personal fees from Abbott Vascular, Abiomed, ReCor Medical, Medtronic, ACIST Medical Systems, Boston Scientific, Pie Medical Imaging, PulseCath, Cardialysis, CardiacBooster, Kaminari Medical, Sanofi, Siemens Healthineers, and Medtronic. Dr Sharp reported receiving personal fees from ReCor Medical, Medtronic, Boston Scientific, Penumbra, and Philips. Dr Lurz reported receiving institutional grants from ReCor Medical, Edwards Lifesciences, and Abbott. Dr Bloch reported receiving personal fees from ReCor Medical and Medtronic. Dr Weber reported receiving personal fees from ReCor Medical, Medtronic, and Ablative Solutions. Dr Lobo reported receiving personal fees from ReCor Medical, Medtronic, Ablative Solutions, and Vascular Dynamics and receiving grants from Medtronic. Dr Basile reported receiving grants from ReCor Medical and Ablative Solutions and receiving personal fees from ReCor Medical, Eli Lilly, and UpToDate. Ms Claude and Dr Reeve-Stoffer reported being employees of ReCor Medical. Dr McClure reported being an employee of NAMSA, which is a contractor for ReCor Medical. Dr Kirtane reported institutional funding given to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, Abiomed, Cardiovascular Systems Inc, CathWorks, Siemens Healthineers, Philips, ReCor Medical, Neurotronics, Biotronik, Chiesi Farmaceutici, Bolt Medical, Magenta Medical, Canon Medical Systems, SoniVie, Shockwave Medical, and Merck and receiving personal fees from Neurotronics, Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc, Interventional Medical Device Systems, CathWorks, Siemens Healthineers, Philips, ReCor Medical, Chiesi Farmaceutici, OpSens Medical, ZOLL Medical, and Regeneron Pharmaceuticals. No other disclosures were reported.

Figures

**Figure 1.. Patient Flow Through the RADIANCE II Trial**
RADIANCE indicates A Study of the ReCor Medical Paradise System in Clinical Hypertension.

**Figure 2.. Twenty-Four Hour Ambulatory Profiles of Systolic Blood Pressure in Patients With Complete Ambulatory Measurements at Baseline and at 2 Months**
There were 145 patients in the ultrasound renal denervation group and 73 patients in the sham procedure group with complete data. Data are expressed as mean (95% CI).

**Figure 3.. Individual Changes From Baseline to 2 Months in Daytime Ambulatory Systolic Blood Pressure in Patients With Complete Ambulatory Measurements**
There were 145 patients in the ultrasound renal denervation group and 73 patients in the sham procedure group with complete data. There were 22 patients (total from both groups combined) who restarted antihypertensive treatment for any reason.

See this image and copyright information in PMC

Comment in

In hypertension not treated with medications, renal denervation vs. sham reduced daytime ambulatory SBP at 2 mo.
Samuels JA, Molony DA. Samuels JA, et al. Ann Intern Med. 2023 Jun;176(6):JC68. doi: 10.7326/J23-0040. Epub 2023 Jun 6. Ann Intern Med. 2023. PMID: 37276593

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What are the ideal metrics for assessing the quality of long-term stabilized "perfect" 24-h BP control after renal denervation?
Kario K. Kario K. Hypertens Res. 2024 Oct;47(10):2644-2651. doi: 10.1038/s41440-024-01859-5. Epub 2024 Aug 28. Hypertens Res. 2024. PMID: 39191961 Review.
Two Incorrect Names.
[No authors listed] [No authors listed] JAMA. 2023 Jun 13;329(22):1989. doi: 10.1001/jama.2023.8136. JAMA. 2023. PMID: 37314287 Free PMC article. No abstract available.
Efficacy and Safety of Ultrasound Renal Denervation on Office Blood Pressure of Patients with Resistant Arterial Hypertension: A Systematic Review and Meta-analysis.
Maia JG, Kelly FA, Gonçalves OR, de Moraes FCA, de Sousa MG, Consolim-Colombo FM. Maia JG, et al. High Blood Press Cardiovasc Prev. 2024 Nov;31(6):657-667. doi: 10.1007/s40292-024-00671-z. Epub 2024 Oct 29. High Blood Press Cardiovasc Prev. 2024. PMID: 39472408
Renal denervation ameliorates atrial remodeling in type 2 diabetic rats by regulating mitochondrial dynamics.
Huo JY, Hou C, Li XL, Yang L, Jiang WY. Huo JY, et al. J Physiol Biochem. 2024 Nov;80(4):935-948. doi: 10.1007/s13105-024-01054-7. Epub 2024 Oct 22. J Physiol Biochem. 2024. PMID: 39436584
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Fisher NDL, Kirtane AJ. Fisher NDL, et al. Nat Rev Cardiol. 2025 Sep;22(9):664-674. doi: 10.1038/s41569-024-01104-z. Epub 2025 Jan 2. Nat Rev Cardiol. 2025. PMID: 39743561 Review.

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References

1. Zhou B, Carrillo-Larco RM, Danaei G, et al. ; NCD Risk Factor Collaboration (NCD-RisC) . Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980. doi:10.1016/S0140-6736(21)01330-1 - DOI - PMC - PubMed
1. Muntner P, Hardy ST, Fine LJ, et al. . Trends in blood pressure control among US adults with hypertension, 1999-2000 to 2017-2018. JAMA. 2020;324(12):1190-1200. doi:10.1001/jama.2020.14545 - DOI - PMC - PubMed
1. Whelton PK, Carey RM, Aronow WS, et al. . 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2018;138(17):e426-e483. doi:10.1161/CIR.0000000000000597 - DOI - PubMed
1. Williams B, Mancia G, Spiering W, et al. ; ESC Scientific Document Group . 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021-3104. doi:10.1093/eurheartj/ehy339 - DOI - PubMed
1. Choudhry NK, Kronish IM, Vongpatanasin W, et al. ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology . Medication adherence and blood pressure control: a scientific statement from the American Heart Association. Hypertension. 2022;79(1):e1-e14. doi:10.1161/HYP.0000000000000203 - DOI - PMC - PubMed

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[1] Zhou B, Carrillo-Larco RM, Danaei G, et al. ; NCD Risk Factor Collaboration (NCD-RisC) . Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980. doi:10.1016/S0140-6736(21)01330-1 - DOI - PMC - PubMed

[2] Zhou B, Carrillo-Larco RM, Danaei G, et al. ; NCD Risk Factor Collaboration (NCD-RisC) . Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980. doi:10.1016/S0140-6736(21)01330-1 - DOI - PMC - PubMed

[3] Muntner P, Hardy ST, Fine LJ, et al. . Trends in blood pressure control among US adults with hypertension, 1999-2000 to 2017-2018. JAMA. 2020;324(12):1190-1200. doi:10.1001/jama.2020.14545 - DOI - PMC - PubMed

[4] Muntner P, Hardy ST, Fine LJ, et al. . Trends in blood pressure control among US adults with hypertension, 1999-2000 to 2017-2018. JAMA. 2020;324(12):1190-1200. doi:10.1001/jama.2020.14545 - DOI - PMC - PubMed

[5] Whelton PK, Carey RM, Aronow WS, et al. . 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2018;138(17):e426-e483. doi:10.1161/CIR.0000000000000597 - DOI - PubMed

[6] Whelton PK, Carey RM, Aronow WS, et al. . 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2018;138(17):e426-e483. doi:10.1161/CIR.0000000000000597 - DOI - PubMed

[7] Williams B, Mancia G, Spiering W, et al. ; ESC Scientific Document Group . 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021-3104. doi:10.1093/eurheartj/ehy339 - DOI - PubMed

[8] Williams B, Mancia G, Spiering W, et al. ; ESC Scientific Document Group . 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021-3104. doi:10.1093/eurheartj/ehy339 - DOI - PubMed

[9] Choudhry NK, Kronish IM, Vongpatanasin W, et al. ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology . Medication adherence and blood pressure control: a scientific statement from the American Heart Association. Hypertension. 2022;79(1):e1-e14. doi:10.1161/HYP.0000000000000203 - DOI - PMC - PubMed

[10] Choudhry NK, Kronish IM, Vongpatanasin W, et al. ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology . Medication adherence and blood pressure control: a scientific statement from the American Heart Association. Hypertension. 2022;79(1):e1-e14. doi:10.1161/HYP.0000000000000203 - DOI - PMC - PubMed

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Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Collaborators

Affiliations

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Authors

Collaborators

Affiliations

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