36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

Michael J Bloch; Ajay J Kirtane; Michel Azizi; Felix Mahfoud; Jan Basile; Joost Daemen; Manish Saxena; Lisa Thackeray; Maureen McGuire; Lisa Claude; Roland E Schmieder; RADIANCE-HTN Investigators

doi:10.1038/s41440-024-01854-w

36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

Hypertens Res. 2024 Sep 27. doi: 10.1038/s41440-024-01854-w. Online ahead of print.

Authors

Michael J Bloch^{1

2}, Ajay J Kirtane³, Michel Azizi^{4

5

6}, Felix Mahfoud^{7

8}, Jan Basile⁹, Joost Daemen¹⁰, Manish Saxena¹¹, Lisa Thackeray¹², Maureen McGuire¹³, Lisa Claude¹³, Roland E Schmieder¹⁴; RADIANCE-HTN Investigators

Collaborators

RADIANCE-HTN Investigators:
Yale Wang, Nedaa Skeik, Richard Bae, Amy McMeans, JoAnne Goldman, Rose Peterson, James Stephen Jenkins, Isabelle Tutor, Michael Harrison, Angel Penning, Chandan Devireddy, Janice Lea, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, Anne Tran, Kirin Bhatia, Naomi D L Fisher, Piotr Sobieszczyk, Ian Halliday, Tay Munson, Jason Lindsey, Steven Laster, Mathew Bunte, Anthony Hart, Dana King, Jamie Hall, Kintur Sanghvi, Courtney Krathen, Luot Lewis, Ashley Willitts, Thomas Todoran, Jan Basile, Anthony Awkar, Casey Palmer, Anna Tecklenburg, John Schindler, John Pacella, Matthew Muldoon, MaryJo Albright, Tracy Nicholson, John Flack, 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, Ajay J Kirtane, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Matheen Khuddus, Suzanne Zentko, Abby Touchton, Marti Roberson, Michael J Bloch, 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 Gallapudi, Joel Cohn, Kevin Rogers, Manish Saxena, Anthony Mathur, Ajay Jain, Armida Balawon, Oliver Zongo, Christine Topham, Andrew Sharp, Richard Anderson, Elizabeth Thompson, Nikki Spiro, Elizabeth Hodges, Jaqueline Holder, 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, Felix Mahfoud, Lucas Lauder, Saarraaken Kulenthiran, Christina Koch, Angelika Wachter, Roland Schmieder, Axel Schmid, Dennis Kannenkeril, Ulrike Heinritz, Kerstin Endres-Frohlich, Philipp Lurz, Karl 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, Michel Azizi, Marc Sapoval, Marine Livrozet, Asma Regrag, Valerie Paquet, Pascal Delsart, Justin Hennicaux, Coralie Sommeville, Fabien Bertrand, Joost Daemen, Melvin Lafeber, Victor Zeijen, Amo Ruiter, Elisabeth Huijskens, Jan van Ramshorst, Panagiotis Xaplanteris, Rachid Briki, Quentin de Hemptinne, Severine Pascal, Katty Renard, Pascal Lefebvre, Bert Ferdinande, Juan F Iglesias, Georg Ehert, Laetitia Gallego, Kevin Dobretz, Sylviane Bottone, Josh Costello, Courtney Krathan, Andrew McElvarr, John Reilly, Stephen Jenkins, Michael Cash, Shannon Williams, Maria Jarvis, Cheryl Laffer, Mark Robbins, Sarita Maddel, Maryanne Ducey, Suzanne Rose, Elizabeth DelMastro, Sripal Bangalore, Stephen Williams, Stanley Cabos, Carolina Rodriguez Alvarez, Eric Powers, Emily Hodskins, Vijay Paladugu, Bryan Wells, Hyun-Min Kim, Mohammad Rashid, Theophilus Owan, Iran Lavasani, Hailey Neilson, David Calhoun, Thomas McElderry, William Maddox, Suzanne Oparil, Sheila Kinder, Joseph Garasic, Doug Drachman, Randy Zusman, Kenneth Rosenfield, Danny Do, James O'Meara, Ilie Barb, Abby Foster, Alice Boyette, Desmond Jay, Robert Schwartz, Jo Anne Goldman, Jessie Goldman, Gary Ledley, Nancy Katof, Srinivasa Potluri, Scott Biedermann Jacquelyn Ward, Megan White, Laura Mauri, Piotr Sobieszczky, Alex Smith, Laura Aseltine, Eric Pauley, Tyrone Wade, David Zidar, Mehdi Shishehbor, Barry Effron, Marco Costa, Terence Semenec, Chanwit Roongsritong, Priscilla Nelson, Debbie Cohen, Jay Giri, Robin Neubauer, Thu Vo, Atul R Chugh, Pei-Hsiu Huang, Powell Jose, Michael Jones, Manish Saxena, Melvin D Lobo, Anthony Mathur, Ajay Jain, Armida Balawon, Olivier Zongo, Terry Levy, Clare Bent, David Beckett, Nicki Lakeman, Sarah Kennard, Andrew Sharp, Richard J D'Souza, Sarah Statton, Lindsay Wilkes, Christine Anning, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Annaliza Sevillano, Madelaine Ocampo, Robert Gerber, Mohamad Faris, Andrew John Marshall, Janet Sinclair, Hayley Pepper, Justin Davies, Neil Chapman, Paula Burak, Paula Carvelli, Sachin Jadhav, Jane Quinn, Lars Christian Rump, Johannes Stegbauer, Lars Schimmöller, Sebastian Potthoff, Claudia Schmid, Sylvia Roeder, Lukas Hafer, Felix Mahfoud, Michael Böhm, Sebastian Ewen, Saarraaken Kulenthiran, Angelika Wachter, Christina Koch, Karl Fengler, Karl-Philipp Rommel, Kai Trautmann, Roland E Schmieder, Christian Ott, Axel Schmid, Michael Uder, Ulrike Heinritz, Kerstin Fröhlich-Endres, Sabine Genth-Zotz, Denise Kämpfner, Armin Grawe, Johannes Höhne, Bärbel Kaesberger, Constantin von Zur Mühlen, Dennis Wolf, Markus Welzel, Gudrun Heinrichs, Barbara Trabitzsch, Hervé Trillaud, Erika Cornu, David Fouassier, Aurélien Lorthioir, Valérie Paquet, Atul Pathak, Benjamin Honton, Marianne Cottin, Frédéric Petit, Pierre Lantelme, Constance Berge, Pierre-Yves Courand, Fatou Langevin, Benjamin Longere, Guillaume Ledieu, François Pontana, Lida Feyz, Arno Ruiter, Elisabeth Huyskens, Peter Blankestijn, Michiel Voskuil, Zwaantina Rittersma, Helma Dolmans, A A Kroon, W H van Zwam, Jeannique Vranken, Claudia de Haan, Alexandre Persu, Jean Renkin, Frédéric Maes, Christophe Beauloye, Jean-Philippe Lengelé, Dominique Huyberechts, Anne Bouvier, Adam Witkowski, Andrzej Januszewicz, Jacek Kądziela, Aleksander Prejbisj, Dagmara Hering, Dariusz Ciecwierz, Milosz J Jaguszewski, Radoslaw Owczuk, Ronald Victor, Courtney Walsh, Jonathan Williams, Sandeep Aggarwal, Scott Biedermann, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Sadat Ali Edroos, Amit Patel, David Beckett, Justin Davies, Neil Chapman, Matthew Shun Shin, James Howard, Andrew S P Sharp, Anil Joseph, Richard D'Souza, Robert Gerber, Mohamad Faris, Andrew John Marshall, Cristina Elorz, Philipp Lurz, Robert Höllriegel, Karl Fengler, Karl-Philipp Rommel, Michael Böhm, Sebastian Ewen, Jelena Lucic, Roland E Schmieder, Christian Ott, Michael Uder, Christian Rump, Johannes Stegbauer, Patric Kröpil

Affiliations

¹ Department of Medicine, University of Nevada School of Medicine, Vascular Care, Reno, NV, USA. michael@bluesprucemed.com.
² Renown Regional Medical Center, Reno, NV, USA. michael@bluesprucemed.com.
³ Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
⁴ Université Paris Cité, F-75006, Paris, France.
⁵ AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, F-75015, Paris, France.
⁶ INSERM, CIC1418, F-75015, Paris, France.
⁷ Chefarzt Klinik für Kardiologie, Universitäres Herzzentrum Basel, Universitätsspital Basel, Basel, Switzerland.
⁸ Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.
⁹ Division of Cardiovascular Medicine, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
¹⁰ Erasmus MC, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, NL, The Netherlands.
¹¹ Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK.
¹² NAMSA, Minneapolis, MN, USA.
¹³ Recor Medical Inc., Palo Alto, CA, USA.
¹⁴ Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.

PMID: 39333663
DOI: 10.1038/s41440-024-01854-w

Abstract

Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by -14.5 ± 26.1/-9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and -8.0 ± 24.5/-5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns.

Keywords: Hypertension; blood pressure; renal denervation; ultrasound.