학술논문
Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program
Document Type
Academic Journal
Author
Azizi, Michel; Sharp, Andrew S.P.; Fisher, Naomi D.L.; Weber, Michael A.; Lobo, Melvin D.; Daemen, Joost; Lurz, Philipp; Mahfoud, Felix; Schmieder, Roland E.; Basile, Jan; Bloch, Michael J.; Saxena, Manish; Wang, Yale; Sanghvi, Kintur; Jenkins, J. Stephen; Devireddy, Chandan; Rader, Florian; Gosse, Philippe; Claude, Lisa; Augustin, Dimitri A.; McClure, Candace K.; Kirtane, Ajay J.; Wang, Yale; Skeik, Nedaa; Bae, Richard; McMeans, Amy; Goldman, JoAnne; Peterson, Rose; Stephen Jenkins, James; Tutor, Isabelle; Harrison, Michael; Penning, Angel; Devireddy, Chandan; Lea, Janice; Fiebach, Amanda; Merlin, Claudia; Rader, Florian; Dohad, Suhail; Tran, Anne; Bhatia, Kirin; Fisher, Naomi D.L.; Sobieszczyk, Piotr; Halliday, Ian; Munson, Tay; Lindsey, Jason; Laster, Steven; Bunte, Mathew; Hart, Anthony; King, Dana; Hall, Jamie; Sanghvi, Kintur; Krathen, Courtney; Lewis, Luot; Willitts, Ashley; Todoran, Thomas; Basile, Jan; Awkar, Anthony; Palmer, Casey; Tecklenburg, Anna; Schindler, John; Pacella, John; Muldoon, Matthew; Albright, MaryJo; Nicholson, Tracy; Flack, John; Chami, Youseff; Hafiz, Abdul Moiz; Starkey, Emily; Adams, Kristal; Bernardo, Nelson; Veis, Judith; Hashim, Hayder; Singh, Suman; Whitman, Donna; Stouffer, Rick; Hinderliter, Alan; Allen, Meghan; Scholl, Tatum; Fong, Pete; Gainer, James; Crook, Sherron; Hatchcock, Ellen; Cohen, Debbie; Giri, Jay; Kobayashi, Taisei; Neubauer, Robin; Naidu, Suveeksha; Kirtane, Ajay J.; Radhakrishnan, Jai; Batres, Candido; Edwards, Suzanne; Khuddus, Matheen; Zentko, Suzanne; Touchton, Abby; Roberson, Marti; Bloch, Michael J.; Akinapelli, Abhilash; English, Lisa; Neumann, Bridget; Mendelsohn, Farrel; Brantley, Hutton; Cawthon, Thomas; DeRamus, Susan; Wade, Wesley; Fishman, Robert; Tuohy, Edward; LeBlanc, Jessica; McCurry, Tina; Krishnaswamy, Amar; Laffin, Luke; Bajzer, Christopher; Boros, Marilyn; Branche, Monica; Abraham, Josephine; Abraham, Anu; Stijleman, Inge; Hsi, David; Martin, Scott; Portnay, Edward; Fiebach, Maryann; Garavito, Carolina; Adams, Todd; Teklinski, Andrew; Leech, Adam; Drilling, Patrick; Tulik, Lynda; Benzuly, Keith; Paparello, James; Fintel, Dan; Ramirez, Haydee; Kats, Lauren; Huang, Paul; Biswas, Santanu; Risher, Serena; Pratt, Kristina; Ibebuogu, Uzoma; Johnson, Karen; Cushman, William; Jones, Lisa; Jackson, Leigh; Landers, David; Pasala, Tilak; Salazer, Thomas; Canino, Peter; Arakelian, Patricia; Yang, Yi-Ming; Khaliq, Asma; Weinberg, Mitchell; Abetu, Yihenew; Gulliver, Alana; Reilly, J.P.; Garasic, Joseph; Chugh, Atul; Bertolet, Barry; Go, Brian; Gallapudi, Raghava; Cohn, Joel; Rogers, Kevin; Saxena, Manish; Mathur, Anthony; Jain, Ajay; Balawon, Armida; Zongo, Oliver; Topham, Christine; Sharp, Andrew; Anderson, Richard; Thompson, Elizabeth; Spiro, Nikki; Hodges, Elizabeth; Holder, Jaqueline; Ellam, Timothy; Bagnall, Alan; Jackson, Ralph; Bridgett, Victoria; Wilson, Peter; Das, Neelanjan; Doulton, Timothy; Loader, David; Hector, Gemma; Levy, Terry; Bent, Clare; Kodoth, Vivek; Horler, Stephanie; Nix, Sara; Robinson, Nicholas; Al-Janabi, Firas; Sayer, Jeremy; Ganesh Iyer, Sudha; Redman, Emily; Ramirez, Jonaifah; Padmanabhan, Sandosh; Sharif, Faisal; Alhmoudi, Aishah; Lunardi, Mattia; Coen, Eileen; Glynn, Nicola; Mahfoud, Felix; Lauder, Lucas; Kulenthiran, Saarraaken; Koch, Christina; Wachter, Angelika; Schmieder, Roland; Schmid, Axel; Kannenkeril, Dennis; Heinritz, Ulrike; Endres-Frohlich, Kerstin; Lurz, Philipp; Rommel, Karl; Fengler; Petzold, Martin; Büttner, Margit; Weil, Joachim; Agdirlioglu, Tolga; Köllner, Tanja; Stephan, Jeannine; Dagkonakis, Nikolaos; Hamann, Frank; Ettl, Ute; Petzsche, Ulrike; Reimer, Peter; Hausberg, Martin; Hinrichs, Ralf; Di Ponio-Voit, Isabella; Lutz, Matthias; Gosse, Philippe; Cremer, Antoine; Papadopoulos, Panteleimon; Gaudissard, Julie; Maire, Florent; Azizi, Michel; Sapoval, Marc; Livrozet, Marine; Regrag, Asma; Paquet, Valerie; Delsart, Pascal; Hennicaux, Justin; Sommeville, Coralie; Bertrand, Fabien; Daemen, Joost; Lafeber, Melvin; Zeijen, Victor; Ruiter, Amo; Huijskens, Elisabeth; van Ramshorst, Jan; Xaplanteris, Panagiotis; Briki, Rachid; de Hemptinne, Quentin; Pascal, Severine; Renard, Katty; Ferdinande, Bert; Iglesias, Juan F.; Ehert, Georg; Gallego, Laetitia; Dobretz, Kevin; Bottone, Sylviane; Sanghvi, Kintur; Costello, Josh; Krathan, Courtney; Lewis, Luot; McElvarr, Andrew; Reilly, John; Jenkins, Stephen; Cash, Michael; Williams, Shannon; Jarvis, Maria; Fong, Pete; Laffer, Cheryl; Gainer, James; Robbins, Mark; Crook, Sherron; Maddel, Sarita; Hsi, David; Martin, Scott; Portnay, Edward; Ducey, Maryanne; Rose, Suzanne; DelMastro, Elizabeth; Bangalore, Sripal; Williams, Stephen; Cabos, Stanley; Rodriguez Alvarez, Carolina; Todoran, Thomas; Basile, Jan; Powers, Eric; Hodskins, Emily; Paladugu, Vijay; Tecklenburg, Anna; Devireddy, Chandan; Lea, Janice; Wells, Bryan; Fiebach, Amanda; Merlin, Claudia; Rader, Florian; Dohad, Suhail; Kim, Hyun-Min; Rashid, Mohammad; Abraham, Josephine; Owan, Theophilus; Abraham, Anu; Lavasani, Iran; Neilson, Hailey; Calhoun, David; McElderry, Thomas; Maddox, William; Oparil, Suzanne; Kinder, Sheila; Kirtane, Ajay J.; Radhakrishnan, Jai; Batres, Candido; Edwards, Suzanne; Garasic, Joseph; Drachman, Doug; Zusman, Randy; Rosenfield, Kenneth; Do, Danny; Khuddus, Matheen; Zentko, Suzanne; O’Meara, James; Barb, Ilie; Foster, Abby; Boyette, Alice; Wang, Yale; Jay, Desmond; Skeik, Nedaa; Schwartz, Robert; Peterson, Rose; Goldman, Jo Anne; Goldman, Jessie; Ledley, Gary; Katof, Nancy; Potluri, Srinivasa; Biedermann, Scott; Ward, Jacquelyn; White, Megan; Fisher, Naomi D.L.; Mauri, Laura; Sobieszczky, Piotr; Smith, Alex; Aseltine, Laura; Stouffer, Rick; Hinderliter, Alan; Pauley, Eric; Wade, Tyrone; Zidar, David; Shishehbor, Mehdi; Effron, Barry; Costa, Marco; Semenec, Terence; Bloch, Michael J.; Roongsritong, Chanwit; Nelson, Priscilla; Neumann, Bridget; Cohen, Debbie; Giri, Jay; Neubauer, Robin; Vo, Thu; Chugh, Atul R.; Huang, Pei-Hsiu; Jose, Powell; Flack, John; Fishman, Robert; Jones, Michael; Adams, Todd; Bajzer, Christopher; Saxena, Manish; Lobo, Melvin D.; Mathur, Anthony; Jain, Ajay; Balawon, Armida; Zongo, Olivier; Levy, Terry; Bent, Clare; Beckett, David; Lakeman, Nicki; Kennard, Sarah; Sharp, Andrew; D’Souza, Richard J.; Statton, Sarah; Wilkes, Lindsay; Anning, Christine; Sayer, Jeremy; Ganesh Iyer, Sudha; Robinson, Nicholas; Sevillano, Annaliza; Ocampo, Madelaine; Gerber, Robert; Faris, Mohamad; John Marshall, Andrew; Sinclair, Janet; Pepper, Hayley; Davies, Justin; Chapman, Neil; Burak, Paula; Carvelli, Paula; Jadhav, Sachin; Quinn, Jane; Christian Rump, Lars; Stegbauer, Johannes; Schimmöller, Lars; Potthoff, Sebastian; Schmid, Claudia; Roeder, Sylvia; Weil, Joachim; Hafer, Lukas; Agdirlioglu, Tolga; Köllner, Tanja; Mahfoud, Felix; Böhm, Michael; Ewen, Sebastian; Kulenthiran, Saarraaken; Wachter, Angelika; Koch, Christina; Lurz, Philipp; Fengler, Karl; Rommel, Karl-Philipp; Trautmann, Kai; Petzold, Martin; Schmieder, Roland E.; Ott, Christian; Schmid, Axel; Uder, Michael; Heinritz, Ulrike; Fröhlich-Endres, Kerstin; Genth-Zotz, Sabine; Kämpfner, Denise; Grawe, Armin; Höhne, Johannes; Kaesberger, Bärbel; von zur Mühlen, Constantin; Wolf, Dennis; Welzel, Markus; Gosse, Philippe; Cremer, Antoine; Trillaud, Hervé; Papadopoulos, Panteleimon; Maire, Florent; Gaudissard, Julie; Azizi, Michel; Sapoval, Marc; Cornu, Erika; Fouassier, David; Livrozet, Marine; Lorthioir, Aurélien; Paquet, Valérie; Pathak, Atul; Honton, Benjamin; Cottin, Marianne; Petit, Frédéric; Lantelme, Pierre; Berge, Constance; Courand, Pierre-Yves; Langevin, Fatou; Delsart, Pascal; Longere, Benjamin; Ledieu, Guillaume; Pontana, François; Sommeville, Coralie; Bertrand, Fabien; Daemen, Joost; Feyz, Lida; Zeijen, Victor; Ruiter, Arno; Huyskens, Elisabeth; Blankestijn, Peter; Voskuil, Michiel; Rittersma, Zwaantina; Dolmans, Helma; Kroon, A.A.; van Zwam, W.H.; Vranken, Jeannique; de Haan, Claudia; Persu, Alexandre; Renkin, Jean; Maes, Frédéric; Beauloye, Christophe; Lengelé, Jean-Philippe; Huyberechts, Dominique; Bouvier, Anne; Witkowski, Adam; Januszewicz, Andrzej; Kądziela, Jacek; Prejbisj, Aleksander; Hering, Dagmara; Ciecwierz, Dariusz; Jaguszewski, Milosz J.; Owczuk, Radoslaw; Ciecwierz, Dariusz; Jaguszewski, Milosz J.; Wang, Yale; Jay, Desmond; Skeik, Nedaa; Schwartz, Robert; Rader, Florian; Dohad, Suhail; Victor, Ronald; Sanghvi, Kintur; Costello, Josh; Walsh, Courtney; Abraham, Josephine; Owan, Theophilus; Abraham, Anu; Fisher, Naomi D.L.; Mauri, Laura; Sobieszczky, Piotr; Williams, Jonathan; Bloch, Michael J.; Roongsritong, Chanwit; Todoran, Thomas; Basile, Jan; Powers, Eric; Hodskins, Emily; Fong, Pete; Laffer, Cheryl; Gainer, James; Robbins, Mark; Reilly, John; Cash, Michael; Goldman, Jessie; Aggarwal, Sandeep; Ledley, Gary; Hsi, David; Martin, Scott; Portnay, Edward; Calhoun, David; McElderry, Thomas; Maddox, William; Oparil, Suzanne; Huang, Pei-Hsiu; Jose, Powell; Khuddus, Matheen; Zentko, Suzanne; O’Meara, James; Barb, Ilie; Garasic, Joseph; Drachman, Doug; Zusman, Randy; Rosenfield, Kenneth; Devireddy, Chandan; Lea, Janice; Wells, Bryan; Stouffer, Rick; Hinderliter, Alan; Pauley, Eric; Potluri, Srinivasa; Biedermann, Scott; Bangalore, Sripal; Williams, Stephen; Zidar, David; Shishehbor, Mehdi; Effron, Barry; Costa, Marco; Kirtane, Ajay J.; Radhakrishnan, Jai; Lobo, Melvin D.; Mathur, Anthony; Jain, Ajay; Sayer, Jeremy; Ganesh Iyer, Sudha; Robinson, Nicholas; Ali Edroos, Sadat; Levy, Terry; Patel, Amit; Beckett, David; Bent, Clare; Davies, Justin; Chapman, Neil; Shun Shin, Matthew; Howard, James; Sharp, Andrew S.P.; Joseph, Anil; D’Souza, Richard; Gerber, Robert; Faris, Mohamad; John Marshall, Andrew; Elorz, Cristina; Lurz, Philipp; Höllriegel, Robert; Fengler, Karl; Rommel, Karl-Philipp; Mahfoud, Felix; Böhm, Michael; Ewen, Sebastian; Lucic, Jelena; Schmieder, Roland E.; Ott, Christian; Schmid, Axel; Uder, Michael; Rump, Christian; Stegbauer, Johannes; Kröpil, Patric; Azizi, Michel; Sapoval, Marc; Cornu, Erika; Fouassier, David; Gosse, Philippe; Cremer, Antoine; Trillaud, Hervé; Papadopoulos, Panteleimon; Pathak, Atul; Honton, Benjamin; Lantelme, Pierre; Berge, Constance; Courand, Pierre-Yves; Daemen, Joost; Feyz, Lida; Blankestijn, Peter; Voskuil, Michiel; Rittersma, Zwaantina; Kroon, A.A.; van Zwam, W.H.; Persu, Alexandre; Renkin, Jean
Source
Circulation. Mar 05, 2024 149(10):747-759
Subject
Language
English
ISSN
0009-7322
Abstract
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.