Portal de Periódicos da CAPES

Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

2018; Elsevier BV; Volume: 391; Issue: 10137 Linguagem: Inglês

10.1016/s0140-6736(18)31082-1

1474-547X

Michel Azizi, Roland E. Schmieder, Felix Mahfoud, Michael A. Weber, Joost Daemen, Justin Davies, Jan Basile, Ajay J. Kirtane, Yale Wang, Melvin D. Lobo, Manish Saxena, Lida Feyz, Florian Rader, Philipp Lurz, Jeremy Sayer, Marc Sapoval, Terry Levy, Kintur Sanghvi, Josephine Abraham, Andrew S.P. Sharp, Naomi D.L. Fisher, Michael J. Bloch, Helen Reeve-Stoffer, Leslie Coleman, Christopher M. Mullin, Laura Mauri, Yale Wang, Desmond Jay, Nedaa Skeik, Robert 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 Todoran, Jan Basile, Eric R. Powers, Emily Hodskins, Pete Fong, Cheryl Laffer, James Gainer, Mark Robbins, John P. Reilly, Michael Cash, Jessie Goldman, Sandeep Aggarwal, Gary S. Ledley, David H. Hsi, Scott Martin, Edward Portnay, David 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 Wells, Rick Stouffer, Alan Hinderliter, Eric Pauley, Srinivasa Potluri, Scott Biedermann, Sripal Bangalore, Stephen Williams, David Zidar, Mehdi Shishehbor, Barry Effron, Marco Costa, Ajay J. Kirtane, Jai Radhakrishnan, Melvin D. Lobo, Manish Saxena, Anthony Mathur, Ajay Jain, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Sadat Ali Edroos, Terry Levy, Amit Patel, David Beckett, Clare Bent, Justin 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, Justin Davies, Axel Schmid, Michael Uder, Lars Christian Rump, Johannes Stegbauer, Patric Kröpil, Michel Azizi, Marc Sapoval, Erika Cornu, David Fouassier, Philippe Gosse, Antoine Cremer, 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,

Sodium Intake and Health

Background Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. Methods RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic–diastolic hypertension aged 18–75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Findings Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (−8·5 mm Hg, SD 9·3) than with the sham procedure (−2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: −6·3 mm Hg, 95% CI −9·4 to −3·1, p=0·0001). No major adverse events were reported in either group. Interpretation Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Funding ReCor Medical.