Browse by author
Lookup NU author(s): Dr Tim Ellam, Dr Alan Bagnall, Vikki Bridgett, Peter Wilson, Dr Sebastian Potthoff
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
© 2023 American Medical Association. All rights reserved.IMPORTANCE Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important. OBJECTIVE To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy. DATA SOURCES A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials. STUDY SELECTION Trials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up. DATA EXTRACTION AND SYNTHESIS Pooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials. MAIN OUTCOMES AND MEASURES The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups. RESULTS A total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: -10.4 mm Hg vs -3.4 mm Hg; mean difference, -6.4 mm Hg; 95% CI, - 9.1 to -3.6 mm Hg; home SBP: -8.4 mm Hg vs -1.4 mm Hg; mean difference, -6.8 mm Hg; 95% CI, -8.7 to -4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups. CONCLUSIONS AND RELEVANCE Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.
Author(s): Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M, McClure CK, Chertow G, Dauerman H, Kahan T, Ullery S, Chandra V, Beohar N, Dogan O, Mokrzycki M, Mullaney S, Redfors B, Vefali H, Abbott JD, Loening A, Zagoria R, Skeik N, Bae R, McMeans A, Goldman JA, Peterson R, Tutor I, Harrison M, Penning A, Lea J, Fiebach A, Merlin C, Dohad S, Tran A, Bhatia K, Sobieszczyk P, Halliday I, Munson T, Lindsey J, Laster S, Bunte M, Hart A, King D, Hall J, Krathen C, Lewis L, Willitts A, Todoran T, Awkar A, Palmer C, Tecklenburg A, Schindler J, Pacella J, Muldoon M, Albright MJ, Nicholson T, Flack J, Chami Y, Hafiz AM, Starkey E, Adams K, Bernardo N, Veis J, Hashim H, Singh S, Whitman D, Stouffer R, Hinderliter A, Allen M, Scholl T, Fong P, Gainer J, Crook S, Hatchcock E, Cohen D, Giri J, Kobayashi T, Neubauer R, Naidu S, Radhakrishnan J, Batres C, Edwards S, Khuddus M, Zentko S, Touchton A, Roberson M, Akinapelli A, English L, Neumann B, Mendelsohn F, Brantley H, Cawthon T, DeRamus S, Wade W, Fishman R, Tuohy E, LeBlanc J, McCurry T, Krishnaswamy A, Laffin L, Bajzer C, Boros M, Branche M, Abraham J, Abraham A, Stijleman I, Hsi D, Martin S, Portnay E, Fiebach M, Garavito C, Adams T, Teklinski A, Leech A, Drilling P, Tulik L, Benzuly K, Paparello J, Fintel D, Ramirez H, Kats L, Huang P, Biswas S, Risher S, Pratt K, Ibebuogu U, Johnson K, Cushman W, Jones L, Jackson L, Landers D, Pasala T, Salazer T, Canino P, Arakelian P, Yang Y-M, Khaliq A, Weinberg M, Abetu Y, Gulliver A, Reilly JP, Garasic J, Chugh AR, Bertolet B, Go B, Gallapudi R, Cohn J, Rogers K, Mathur A, Jain A, Balawon A, Zongo O, Topham C, Anderson R, Thompson E, Spiro N, Hodges E, Holder J, Ellam T, Bagnall A, Jackson R, Bridgett V, Wilson P, Das N, Doulton T, Loader D, Hector G, Levy T, Bent C, Kodoth V, Horler S, Nix S, Robinson N, Al-Janabi F, Sayer J, Iyer SG, Redman E, Ramirez J, Padmanabhan S, Sharif F, Alhmoudi A, Lunardi M, Coen E, Glynn N, Lauder L, Kulenthiran S, Koch C, Wachter A, Schmid A, Kannenkeril D, Heinritz U, Endres-Frohlich K, Rommel K-P, Fengler K, Petzold M, Buttner M, Weil J, Agdirlioglu T, Kollner T, Stephan J, Dagkonakis N, Hamann F, Ettl U, Petzsche U, Reimer P, Hausberg M, Hinrichs R, Di Ponio-Voit I, Lutz M, Cremer A, Papadopoulos P, Gaudissard J, Maire F, Livrozet M, Regrag A, Paquet V, Delsart P, Hennicaux J, Bailly-Sommeville C, Bertrand F, Lafeber M, Zeijen V, Ruiter A, Huijskens E, van Ramshorst J, Xaplanteris P, Briki R, de Hemptinne Q, Pascal S, Renard K, Lefebvre P, Ferdinande B, Iglesias J, Ehert G, Gallego L, Dobretz K, Bottone S, Costello J, Krathan C, McElvarr A, Reilly J, Cash M, Williams S, Jarvis M, Laffer C, Robbins M, Maddel S, Ducey M, Rose S, DelMastro E, Bangalore S, Williams S, Cabos S, Alvarez CR, Powers E, Hodskins E, Paladugu V, Wells B, Kim H-M, Rashid M, Owan T, Lavasani I, Neilson H, Calhoun D, McElderry T, Maddox W, Oparil S, Kinder S, Drachman D, Zusman R, Rosenfield K, Do D, O'Meara J, Barb I, Foster A, Boyette A, Jay D, Schwartz R, Goldman J, Ledley G, Katof N, Potluri S, Biedermann S, Ward J, White M, Mauri L, Sobieszczky P, Smith A, Aseltine L, Pauley E, Wade T, Zidar D, Shishehbor M, Effron B, Costa M, Semenec T, Roongsritong C, Nelson P, Vo T, Huang P-H, Jose P, Jones M, Beckett D, Lakeman N, Kennard S, D'Souza RJ, Statton S, Wilkes L, Anning C, Sevillano A, Ocampo M, Gerber R, Faris M, Marshall AJ, Sinclair J, Pepper H, Davies J, Chapman N, Burak P, Carvelli P, Jadhav S, Quinn J, Rump LC, Stegbauer J, Schimmoller L, Potthoff S, Schmid C, Roeder S, Hafer L, Bohm M, Ewen S, Trautmann K, Ott C, Uder M, Genth-Zotz S, Kampfner D, Grawe A, Hohne J, Kaesberger B, von zur Muhlen C, Wolf D, Welzel M, Heinrichs G, Trabitzsch B, Trillaud H, Cornu E, Fouassier D, Lorthioir A, Pathak A, Honton B, Cottin M, Petit F, Lantelme P, Berge C, Courand P-Y, Langevin F, Longere B, Ledieu G, Pontana F, Feyz L, Ruiter A, Huyskens E, Blankestijn P, Voskuil M, Rittersma Z, Dolmans H, Kroon AA, van Zwam WH, Vranken J, de Haan C, Persu A, Renkin J, Maes F, Beauloye C, Lengele J-P, Huyberechts D, Bouvier A, Witkowski A, Januszewicz A, Kadziela J, Prejbisj A, Hering D, Ciecwierz D, Jaguszewski MJ, Owczuk R, Victor R, Walsh C, Williams J, Aggarwal S, Edroos SA, Patel A, Shin MS, Howard J, Joseph A, Elorz C, Hollriegel R, Lucic J, Kropil P
Publication type: Article
Publication status: Published
Journal: JAMA Cardiology
Year: 2023
Volume: 8
Issue: 5
Pages: 464-473
Print publication date: 01/05/2023
Online publication date: 28/05/2023
Acceptance date: 06/02/2023
ISSN (print): 2380-6583
ISSN (electronic): 2380-6591
Publisher: American Medical Association
URL: https://doi.org/10.1001/jamacardio.2023.0338
DOI: 10.1001/jamacardio.2023.0338
PubMed id: 36853627
Altmetrics provided by Altmetric
