Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation
Authors: Azizi Michel , Mahfoud Felix , Weber Michael A. , Sharp Andrew S. P. , Schmieder Roland E. , Lurz Philipp , Lobo Melvin D. , Fisher Naomi D. L. , Daemen Joost , Bloch Michael J. , Basile Jan , Sanghvi Kintur , Saxena Manish , Gosse Philippe , Jenkins J. Stephen , Levy Terry , Persu Alexandre , Kably Benjamin , Claude Lisa , Reeve-Stoffer Helen , McClure Candace , Kirtane Ajay J. ,   RADIANCE-HTN Investigators, Mullin Christopher , Thackeray Lisa , Chertow Glenn , Kahan Thomas , Dauerman Harold , Ullery Steven , Abbott J. Dawn , Loening Andreas , Zagoria Ron , Costello John , Krathan Courtney , Lewis Luot , McElvarr Andrew , Reilly John , 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 , 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 , 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 , 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 , 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 , Mathur Anthony , Jain Ajay , Balawon Armida , Zongo Olivier , Bent Clare , Beckett David , Lakeman Nicki , Kennard Sarah , D’Souza Richard J. , Statton Sarah , Wilkes Lindsay , Anning Christine , Sayer Jeremy , Iyer Sudha Ganesh , Robinson Nicholas , Sevillano Annaliza , Ocampo Madelaine , Gerber Robert , Faris Mohamad , Marshall Andrew John , Sinclair Janet , Pepper Hayley , Davies Justin , Chapman Neil , Burak Paula , Carvelli Paula , Jadhav Sachin , Quinn Jane , Rump Lars Christian , Stegbauer Johannes , Schimmöller Lars , Potthoff Sebastian , Schmid Claudia , Roeder Sylvia , Weil Joachim , Hafer Lukas , Agdirlioglu Tolga , Köllner Tanja , Böhm Michael , Ewen Sebastian , Kulenthiran Saarraaken , Wachter Angelika , Koch Christina , Fengler Karl , Rommel Karl-Philipp , Trautmann Kai , Petzold Martin , 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 , Heinrichs Gudrun , Trabitzsch Barbara , Cremer Antoine , Trillaud Hervé , Papadopoulos Panteleimon , Maire Florent , Gaudissard Julie , Sapoval Marc , Livrozet Marine , Lorthioir Aurélien , Amar Laurence , 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 , Feyz Lida , Zeijen Victor , Ruiter Arno , Huysken Elisabeth , Blankestijn Peter , Voskuil Michiel , Rittersma Zwaantina , Dolmans Helma , Kroon A.A. , van Zwam W.H. , Vranken Jeannique , de Haan. Claudia , Renkin Jean , Maes Frédéric  , Beauloye Christophe , Lengelé Jean-Philippe , Huyberechts Dominique , Bouvie Anne , Witkowski Adam , Januszewicz Andrzej , Kądziela Jacek , Prejbisj Aleksander , Hering Dagmara , Ciecwierz Dariusz , Jaguszewski Milosz J. , Owczuk Radoslaw 
Published: November 2022

Importance

Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial.

Objectives

To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications.

Design, Setting, and Participants

This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment.

Interventions

uRDN vs sham procedure in conjunction with added medications to target BP control.

Main Outcomes and Measures

Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety.

Results

A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of −2.4 [16.6] vs −7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups.

Conclusions and Relevance

In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group.

Trial Registration

ClinicalTrials.gov Identifier: NCT02649426