Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program

著者: Michel Azizi, Andrew Sharp, Naomi D.L. Fisher, Michael A. Weber, Melvin D. Lobo, Joost Daemen, Philipp Lurz, Felix Mahfoud, Roland E. Schmieder, Jan Basile, Michael J. Bloch, Manish Saxena, Yale Wang, Kintur Sanghvi, J. Stephen Jenkins, Chandan Devireddy, Florian Rader, Philippe Gosse, Lisa Claude, Dimitri A. Augustin, Candace K. McClure, Ajay J. Kirtane, Yale Wang, Nedaa Skeik, Richard Bae, Amy McMeans, JoAnne Goldman, Rose Peterson, J. Stephen Jenkins, Isabelle Tutor, Michael R. Harrison, Angel Penning, Chandan Devireddy, Janice P. Lea, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, Anne H. Tran, Kirin Bhatia, Naomi D.L. Fisher, Piotr Sobieszczyk, Ian Halliday, Tay Munson, Jason B. Lindsey, Steven B. Laster, Mathew Bunte, Anthony R Hart, Dana E. King, Jamie Hall, Kintur Sanghvi, Courtney Krathen, Luot Lewis, Ashley Willitts, Thomas M. Todoran, Jan Basile, Anthony Awkar, Casey Palmer, Anna Tecklenburg, John Schindler, John Pacella, Matthew F. Muldoon, MaryJo Albright, Tracy L. Nicholson, John M. Flack, Youseff Chami, Abdul Moiz Hafiz, Emily Starkey, Kristal Adams, Nelson L. Bernardo, Judith H. Veis, Hayder Hashim, Suman Singh, Donna Whitman, Rick Stouffer, Alan L. Hinderliter, Meghan Allen, Tatum Scholl, Pete Fong, James S. Gainer, Sherron Crook, Ellen Hatchcock, Debbie L. 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 J. Laffin, Christopher Bajzer, Marilyn Boros, Monica Branche, Josephine Abraham, Anu Abraham, Inge J. Stijleman, David H. Hsi, Scott D. Martin, Edward L. Portnay, Maryann Fiebach, Carolina Garavito, Todd M. Adams, Andrew Teklinski, Adam Leech, Patrick Drilling, Lynda Tulik, Keith Benzuly, James J. Paparello, Dan J. Fintel, Haydee Ramirez, Lauren Kats, Paul L. Huang, Santanu Biswas, Serena Risher, Kristina Pratt, Uzoma N. Ibebuogu, Karen Johnson, William C. Cushman, Lisa Jones, Leigh Jackson, David Landers, Tilak Pasala, Thomas Salazer, Peter Canino, Patricia Arakelian, Yiming Yang, Asma Khaliq, Mitchell Weinberg, Yihenew Abetu, Alana Gulliver, John 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 A. Anderson, Elizabeth Thompson, Nikki Spiro, Elizabeth Hodges, J C 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 E. Schmieder, Axel Schmid, Dennis Kannenkeril, Ulrike Heinritz, Kerstin Endres-Frohlich, Philipp Lurz, K Rommel, 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, R. Hinrichs, Isabella Di Ponio-Voit, Matthias Lutz, Philippe Gosse, Antoine Crémer, Panteleimon Papadopoulos, Julie Gaudissard, Florent Maire, Michel Azizi, Marc Sapoval, Marine Livrozet, Asma Regrag, Valérie Paquet, Pascal Delsart, Justin Hennicaux, Coralie Sommeville, Fabien Bertrand, Joost Daemen, Melvin Lafeber, Victor Zeijen, A.E.C. Ruiter, Elisabeth G. W. Huijskens, Jan van Ramshorst, Panagiotis Xaplanteris, Rachid Briki, Quentin de Hemptinne, Severine Pascal, Katty Renard, Bert Ferdinande, Juan F. Iglesias, Georg Ehert, Laetitia Gallego, Kevin Dobretz, Sylviane Bottone, Kintur Sanghvi, Josh Costello, Courtney Krathan, Luot Lewis, Andrew McElvarr, John P. Reilly, Stephen J. Jenkins, Michael Cash, Shannon Williams, Maria Jarvis, Pete Fong, Cheryl L. Laffer, James S. Gainer, Mark Robbins, Sherron Crook, Sarita Maddel, David H. Hsi, Scott D. Martin, Edward L. Portnay, Maryanne Ducey, Suzanne Rose, Elizabeth DelMastro, Sripal Bangalore, Stephen Williams, Stanley Cabos, Carolina Rodríguez Álvarez, Thomas M. Todoran, Jan Basile, Eric R. Powers, Emily Hodskins, Vijay Paladugu, Anna Tecklenburg, Chandan Devireddy, Janice P. Lea, Bryan J. Wells, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, H. Mike Kim, Mohammad H. Rashid, Josephine Abraham, Theophilus Owan, Anu Abraham, Iran Lavasani, Hailey Neilson, David A. Calhoun, Thomas McElderry, William Maddox, Suzanne Oparil, Sheila Kinder, Ajay J. Kirtane, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Joseph Garasic, Doug Drachman, Randy Zusman, Kenneth Rosenfield, Danny Do, Matheen Khuddus, Suzanne Zentko, James O’Meara, Ilie Barb, Abby Foster, Alice Boyette, Yale Wang, Desmond Jay, Nedaa Skeik, Robert S. Schwartz, Rose Peterson, Jo Anne Goldman, Jessie Goldman, Gary S. Ledley, Nancy Katof, Srinivasa Potluri, Scott Biedermann, Jacquelyn Ward, Megan White, Naomi D.L. Fisher, Laura Mauri, Piotr Sobieszczky, Alex Smith, Laura Aseltine, Rick Stouffer, Alan L. Hinderliter, Eric Pauley, Tyrone Wade, David Zidar, Mehdi H. Shishehbor, Barry Effron, Marco Costa, Terence Semenec, Michael J. Bloch, Chanwit Roongsritong, Priscilla Nelson, Bridget Neumann, Debbie L. Cohen, Jay Giri, Robin Neubauer, Thu Vo, Atul Chugh, Pei‐Hsiu Huang, Powell Jose, John M. Flack, Robert Fishman, Michael Jones, Todd M. Adams, Christopher Bajzer, 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 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 E. Davies, Neil Chapman, Paula Burak, Paula Carvelli, Sachin Jadhav, Jane Quinn, Lars Christian Rump, Johannes Stegbauer, Lars Schimmöller, S. Potthoff, Claudia Schmid, Sylvia Roeder, Joachim Weil, Lukas Hafer, Tolga Agdirlioglu, Tanja Köllner, Felix Mahfoud, Michael Böhm, Sebastian Ewen, Saarraaken Kulenthiran, Angelika Wachter, Christina Koch, Philipp Lurz, Karl Fengler, Karl‐Philipp Rommel, Kai Trautmann, Martin Petzold, Roland E. Schmieder, Christian Ott, Axel Schmid, Michael Uder, Ulrike Heinritz, Kerstin Fröhlich-Endres, Sabine Genth‐Zotz, Denise Kämpfner, Armin Gräwe, Johannes Höhne, Bärbel Kaesberger, Constantin von zur Mühlen, Dennis Wolf, Markus Welzel, Philippe Gosse, Antoine Crémer, Hervé Trillaud, Panteleimon Papadopoulos, Florent Maire, Julie Gaudissard, Michel Azizi, Marc Sapoval, Erika Cornu, David Fouassier, Marine Livrozet, Aurélien Lorthioir, Valérie Paquet, Atul Pathak, Benjamin Honton, Marianne Cottin, Frédéric Petit, Pierre Lantelme, Constance Berge, Pierre‐Yves Courand, Fatou Langevin, Pascal Delsart, Benjamin Longère, Guillaume Ledieu, François Pontana, Coralie Sommeville, Fabien Bertrand, Joost Daemen, Lida Feyz, Victor Zeijen, Arno Ruiter, Elisabeth Huyskens, Peter J. Blankestijn, Michiel Voskuil, Zwaantina Rittersma, Helma Dolmans, Abraham A. Kroon, Wim H. van Zwam, Jeannique Vranken, Claudia de Haan, Alexandre Persu, Jean Renkin, Frédéric Maes, Christophe Beauloye, Jean‐Philippe Lengelé, Dominique Huyberechts, Anne‐Marie Bouvier, Adam Witkowski, Andrzej Januszewicz, Jacek Kądziela, Aleksander Prejbisj, Dagmara Hering, Dariusz Ciećwierz, Miłosz Jaguszewski, Radosław Owczuk, Dariusz Ciećwierz, Miłosz Jaguszewski, Yale Wang, Desmond Jay, Nedaa Skeik, Robert S. Schwartz, Florian Rader, Suhail Dohad, Ronald G. Victor, Kintur Sanghvi, Josh Costello, Courtney Walsh, Josephine Abraham, Theophilus Owan, Anu Abraham, Naomi D.L. Fisher, Laura Mauri, Piotr Sobieszczky, Jonathan S. Williams, Michael J. Bloch, Chanwit Roongsritong, Thomas M. Todoran, Jan Basile, Eric R. Powers, Emily Hodskins, Pete Fong, Cheryl L. Laffer, James S. Gainer, Mark Robbins, John P. Reilly, Michael Cash, Jessie Goldman, Sandeep Aggarwal, Gary S. Ledley, David H. Hsi, Scott D. Martin, Edward L. Portnay, David A. 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 P. Lea, Bryan J. Wells, Rick Stouffer, Alan L. Hinderliter, Eric Pauley, Srinivasa Potluri, Scott Biedermann, Sripal Bangalore, Stephen Williams, David Zidar, Mehdi H. Shishehbor, Barry Effron, Marco Costa, Ajay J. Kirtane, Jai Radhakrishnan, Melvin D. Lobo, Anthony Mathur, Ajay Jain, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Sadat Ali Edroos, Terry Levy, Amit Patel, David Beckett, Clare Bent, Justin E. Davies, Neil Chapman, Matthew Shun Shin, James P. Howard, Andrew Sharp, Anil Joseph, Richard D’Souza, Robert Gerber, Mohamad Faris, Andrew John Marshall, Cristina Elorz, Philipp Lurz, Robert Höllriegel, Karl Fengler, Karl‐Philipp Rommel, Felix Mahfoud, Michael Böhm, Sebastian Ewen, Jelena Lučić, Roland E. Schmieder, Christian Ott, Axel Schmid, Michael Uder, Christian Rump, Johannes Stegbauer, Patric Kröpil, Michel Azizi, Marc Sapoval, Erika Cornu, David Fouassier, Philippe Gosse, Antoine Crémer, Hervé Trillaud, Panteleimon Papadopoulos, Atul Pathak, Benjamin Honton, Pierre Lantelme, Constance Berge, Pierre‐Yves Courand, Joost Daemen, Lida Feyz, Peter J. Blankestijn, Michiel Voskuil, Zwaantina Rittersma, Abraham A. Kroon, Wim H. van Zwam, Alexandre Persu, Jean Renkin - Circulation 2023 被引用: 37

BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT ( P =0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients ( P =0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was −3.0 mm Hg (95% CI, −5.7, −0.2; P =0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were −5.4 mm Hg (−6.8, −4.0; P <0.001) and −5.2 mm Hg (−7.1, −3.3; P <0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT02649426 and NCT03614260.