Endovascular Ultrasound Renal Denervation to Treat Hypertension
Author:
Azizi Michel123, Saxena Manish4, Wang Yale5, Jenkins J. Stephen6, Devireddy Chandan7, Rader Florian8, Fisher Naomi D. L.9, Schmieder Roland E.10, Mahfoud Felix1112, Lindsey Jason13, Sanghvi Kintur14, Todoran Thomas M.1516, Pacella John17, Flack John18, Daemen Joost19, Sharp Andrew S. P.2021, Lurz Philipp22, Bloch Michael J.23, Weber Michael A.24, Lobo Melvin D.4, Basile Jan15, Claude Lisa25, Reeve-Stoffer Helen25, McClure Candace K.26, Kirtane Ajay J.27, Mullin Christopher28, McClure Candace K.28, Thackeray Lisa28, Wang Yongshi28, Chertow Glenn28, Chandra Venita28, Dauerman Harold28, Kahan Thomas28, Ullery Steven28, Beohar Nirat28, Dogan Ozgen28, Mokrzycki Michelle28, Mullaney Scott28, Redfors Bjorn28, Vefali Huseng28, Loening Andreas28, Zagoria Ron28, Skeik Nedaa28, Bae Richard28, McMeans Amy28, Goldman JoAnne28, Peterson Rose28, Tutor Isabelle28, Harrison Michael28, Penning Angel28, Lea Janice28, Fiebach Amanda28, Merlin Claudia28, Dohad Suhail28, Tran Anne28, Bhatia Kirin28, Sobieszczyk Piotr28, Halliday Ian28, Munson Tay28, Laster Steven28, Bunte Mathew28, Hart Anthony28, King Dana28, Hall Jamie28, Krathen Courtney28, Lewis Luot28, Willitts Ashley28, Awkar Anthony28, Palmer Casey28, Tecklenburg Anna28, Schindler John28, Muldoon Matthew28, Albright MaryJo28, Nicholson Tracy28, Chami Youseff28, Hafiz Abdul Moiz28, Starkey Emily28, Adams Kristal28, Bernardo Nelson28, Veis Judith28, Hashim Hayder28, Singh Suman28, Whitman Donna28, Stouffer Rick28, Hinderliter Alan28, Allen Meghan28, Scholl Tatum28, Fong Pete28, Gainer James28, Crook Sherron28, Hatchcock Ellen28, Cohen Debbie28, Giri Jay28, Kobayashi Taisei28, Neubauer Robin28, Naidu Suveeksha28, Radhakrishnan Jai28, Batres Candido28, Edwards Suzanne28, Khuddus Matheen28, Zentko Suzanne28, Touchton Abby28, Roberson Marti28, Akinapelli Abhilash28, English Lisa28, Neumann Bridget28, Mendelsohn Farrel28, Brantley Hutton28, Cawthon Thomas28, DeRamus Susan28, Wade Wesley28, Fishman Robert28, Tuohy Edward28, LeBlanc Jessica28, McCurry Tina28, Krishnaswamy Amar28, Laffin Luke28, Bajzer Christopher28, Boros Marilyn28, Branche Monica28, Abraham Josephine28, Abraham Anu28, Stijleman Inge28, Hsi David28, Martin Scott28, Portnay Edward28, Fiebach Maryann28, Garavito Carolina28, Adams Todd28, Teklinski Andrew28, Leech Adam28, Drilling Patrick28, Tulik Lynda28, Benzuly Keith28, Paparello James28, Fintel Dan28, Ramirez Haydee28, Kats Lauren28, Huang Paul28, Biswas Santanu28, Risher Serena28, Pratt Kristina28, Ibebuogu Uzoma28, Johnson Karen28, Cushman William28, Jones Lisa28, Jackson Leigh28, Landers David28, Pasala Tilak28, Salazer Thomas28, Canino Peter28, Arakelian Patricia28, Yang Yi-Ming28, Khaliq Asma28, Weinberg Mitchell28, Abetu Yihenew28, Gulliver Alana28, Reilly JP28, Garasic Joseph28, Chugh Atul28, Bertolet Barry28, Go Brian28, Gollapudi Raghava28, Cohn Joel28, Rogers Kevin28, Mathur Anthony28, Jain Ajay28, Balawon Armida28, Zongo Oliver28, Topham Christine28, Anderson Richard28, Thompson Elizabeth28, Spiro Nikki28, Hodges Elizabeth28, Ellam Timothy28, Bagnall Alan28, Jackson Ralph28, Bridgett Victoria28, Wilson Peter28, Das Neelanjan28, Doulton Timothy28, Loader David28, Hector Gemma28, Levy Terry28, Bent Clare28, Kodoth Vivek28, Horler Stephanie28, Nix Sara28, Robinson Nicholas28, Al-Janabi Firas28, Sayer Jeremy28, Iyer Sudha Ganesh28, Redman Emily28, Ramirez Jonaifah28, Padmanabhan Sandosh28, Sharif Faisal28, Alhmoudi Aishah28, Lunardi Mattia28, Coen Eileen28, Glynn Nicola28, Lauder Lucas28, Kulenthiran Saarraaken28, Koch Christina28, Wachter Angelika28, Schmid Axel28, Kannenkeril Dennis28, Heinritz Ulrike28, Endres-Frohlich Kerstin28, Rommel Karl Philipp28, Fengler Karl 28, Petzold Martin28, Büttner Margit28, Weil Joachim28, Agdirlioglu Tolga28, Köllner Tanja28, Stephan Jeannine28, Dagkonakis Nikolaos28, Hamann Frank28, Ettl Ute28, Petzsche Ulrike28, Reimer Peter28, Hausberg Martin28, Hinrichs Ralf28, Di Ponio-Voit Isabella28, Lutz Matthias28, Gosse Philippe28, Cremer Antoine28, Papadopoulos Panteleimon28, Gaudissard Julie28, Maire Florent28, Sapoval Marc28, Livrozet Marine28, Regrag Asma28, Paquet Valerie28, Delsart Pascal28, Hennicaux Justin28, Sommeville Coralie28, Bertrand Fabien28, Lafeber Melvin28, Zeijen Victor28, Ruiter Amo28, van Ramshorst Jan28, Xaplanteris Panagiotis28, Briki Rachid28, de Hemptinne Quentin28, Pascal Severine28, Renard Katty28, Lefebvre Pascal28, Ferdinande Bert28, Iglesias Juan F.28, Ehret Georg28, Gallego Laetitia28, Dobretz Kevin28,
Affiliation:
1. Université Paris Cité, Paris, France 2. AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France 3. INSERM, CIC1418, Paris, France 4. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, England 5. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota 6. Ochsner Medical Center, New Orleans, Louisiana 7. Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia 8. Cedars-Sinai Heart Institute, Los Angeles, California 9. Brigham and Women’s Hospital, Boston, Massachusetts 10. Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany 11. Klinik für Innere Medizin III, Saarland University Hospital, Homburg, Germany 12. Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge 13. Saint Luke’s Mid America Heart Institute, Kansas City, Missouri 14. Deborah Heart and Lung Center, Brown Mills, New Jersey 15. Division of Cardiovascular Medicine, Medical University of South Carolina, Charleston 16. Ralph H. Johnson VA Medical Center, Charleston, South Carolina 17. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 18. Springfield Memorial Hospital, Southern Illinois University School of Medicine, Springfield 19. Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, the Netherlands 20. University Hospital of Wales, Cardiff, England 21. University of Exeter, Exeter, England 22. Heart Center Leipzig, University of Leipzig, Leipzig, Germany 23. Vascular Care, Renown Institute of Heart and Vascular Health, Department of Medicine, University of Nevada School of Medicine, Reno 24. Downstate Medical Center, Division of Cardiovascular Medicine, State University of New York, New York 25. ReCor Medical, Inc, Palo Alto, California 26. NAMSA, Minneapolis, Minnesota 27. Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York 28. for the RADIANCE II Investigators and Collaborators
Abstract
ImportanceTwo initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment.ObjectiveTo study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension.Design, Setting, and ParticipantsSham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms.InterventionsUltrasound renal denervation vs a sham procedure.Main Outcomes and MeasuresThe primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months.ResultsAmong 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, −7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, −1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, −6.3 mm Hg [95% CI, −9.3 to −3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group.Conclusions and RelevanceIn patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events.Trial RegistrationClinicalTrials.gov Identifier: NCT03614260
Publisher
American Medical Association (AMA)
Cited by
37 articles.
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