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Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial

2021; Elsevier BV; Volume: 397; Issue: 10293 Linguagem: Inglês

10.1016/s0140-6736(21)00788-1

1474-547X

Michel Azizi, Kintur Sanghvi, Manish Saxena, Philippe Gosse, John P. Reilly, Terry Levy, Lars Christian Rump, Alexandre Persu, Jan Basile, Michael J Bloch, Joost Daemen, Melvin D. Lobo, Felix Mahfoud, Roland E Schmieder, Andrew Sharp, Michael A. Weber, Marc Sapoval, Pete Fong, Atul Pathak, Pierre Lantelme, David H. Hsi, Sripal Bangalore, Adam Witkowski, Joachim Weil, Benjamin Kably, Neil C. Barman, Helen Reeve-Stoffer, Leslie Coleman, Candace K. McClure, Ajay J Kirtane, 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 Laffer, James Gainer, Mark Robbins, Sherron Crook, Sarita Maddel, David H. Hsi, Scott Martin, Edward Portnay, Maryanne Ducey, Suzanne Rose, Elizabeth DelMastro, Sripal Bangalore, Stephen Williams, Stanley Cabos, Carolina Rodríguez Álvarez, Thomas Todoran, Jan Basile, Eric R. Powers, Emily Hodskins, Vijay Paladugu, Anna Tecklenburg, Chandan Devireddy, Janice P. Lea, Bryan Wells, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, H. Mike Kim, Mohammad A Rashid, Josephine Abraham, Theophilus Owan, Anu Abraham, Iran Lavasani, Hailey Neilson, David 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 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 Hinderliter, Eric Pauley, Tyrone Wade, David Zidar, Mehdi 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 R. 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 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, Gudrun Heinrichs, Barbara Trabitzsch, Philippe Gosse, Antoine Cremer, H. 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 Huysken, Peter 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 Bouvie, Adam Witkowski, Andrzej Januszewicz, Jacek Kdziela, Aleksander Prejbisj, Dagmara Hering, Dariusz Ciećwierz, Miłosz Jaguszewski, Radosław Owczuk, Dariusz Ciećwierz, Miłosz Jaguszewski,

Hemodynamic Monitoring and Therapy

Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications.In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426.Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups.Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension.ReCor Medical.