| Title: |
Endovascular Ultrasound Renal Denervation to Treat Hypertension |
| Authors: |
Azizi, Michel; Saxena, Manish; Wang, Yale; Jenkins, J. Stephen; Devireddy, Chandan; Rader, Florian; Fisher, Naomi, D L; Schmieder, Roland, E; Mahfoud, Felix; Lindsey, Jason; Sanghvi, Kintur; Todoran, Thomas, M; Pacella, John; Flack, John; Daemen, Joost; Sharp, Andrew, S P; Lurz, Philipp; Bloch, Michael, J; Weber, Michael, A; Lobo, Melvin, D; Basile, Jan; Claude, Lisa; Reeve-Stoffer, Helen; Mcclure, Candace, K; Kirtane, Ajay, J; Mullin, Christopher; Thackeray, Lisa; Wang, Yongshi; Chertow, Glenn; Chandra, Venita; Dauerman, Harold; Kahan, Thomas; Ullery, Steven; Beohar, Nirat; Dogan, Ozgen; Mokrzycki, Michelle; Mullaney, Scott; Redfors, Bjorn; Vefali, Huseng; Loening, Andreas; Zagoria, Ron; Skeik, Nedaa; Bae, Richard; Mcmeans, Amy; Goldman, Joanne; Peterson, Rose; Tutor, Isabelle; Harrison, Michael; Penning, Angel; Lea, Janice; Fiebach, Amanda; Merlin, Claudia; Dohad, Suhail; Tran, Anne; Bhatia, Kirin; Sobieszczyk, Piotr; Halliday, Ian; Munson, Tay; Laster, Steven; Bunte, Mathew; Hart, Anthony; King, Dana; Hall, Jamie; Krathen, Courtney; Lewis, Luot; Willitts, Ashley; Awkar, Anthony; Palmer, Casey; Tecklenburg, Anna; Schindler, John; Muldoon, Matthew; Albright, Maryjo; Nicholson, Tracy; Chami, Youseff; Hafiz, Abdul Moiz; Starkey, Emily; Adams, Kristal; Bernardo, Nelson; Veis, Judith; Hashim, Hayder; Singh, Suman; Whitman, Donna; Stouffer, Rick; Hinderliter, Alan; Allen, Meghan; Scholl, Tatum; Fong, Pete; Gainer, James; Crook, Sherron; Hatchcock, Ellen; Cohen, Debbie; Giri, Jay; Kobayashi, Taisei; Neubauer, Robin; Naidu, Suveeksha; Radhakrishnan, Jai; Batres, Candido; Edwards, Suzanne; Khuddus, Matheen; Zentko, Suzanne; Touchton, Abby; Roberson, Marti; Akinapelli, Abhilash; English, Lisa; Neumann, Bridget; Mendelsohn, Farrel; Brantley, Hutton; Cawthon, Thomas; Deramus, Susan; Wade, Wesley; Fishman, Robert; Tuohy, Edward; Leblanc, Jessica; Mccurry, Tina; Krishnaswamy, Amar; Laffin, Luke; Bajzer, Christopher; Boros, Marilyn; Branche, Monica; Abraham, Josephine; Abraham, Anu; Stijleman, Inge; Hsi, David; Martin, Scott; Portnay, Edward; Fiebach, Maryann; Garavito, Carolina; Adams, Todd; Teklinski, Andrew; Leech, Adam; Drilling, Patrick; Tulik, Lynda; Benzuly, Keith; Paparello, James; Fintel, Dan; Ramirez, Haydee; Kats, Lauren; Huang, Paul; Biswas, Santanu; Risher, Serena; Pratt, Kristina; Ibebuogu, Uzoma; Johnson, Karen; Cushman, William; Jones, Lisa; Jackson, Leigh; Landers, David; Pasala, Tilak; Salazer, Thomas; Canino, Peter; Arakelian, Patricia; Yang, Yi-Ming; Khaliq, Asma; Weinberg, Mitchell; Abetu, Yihenew; Gulliver, Alana; Reilly, Jp; Garasic, Joseph; Chugh, Atul; Bertolet, Barry; Go, Brian; Gollapudi, Raghava; Cohn, Joel; Rogers, Kevin; Mathur, Anthony; Jain, Ajay; Balawon, Armida; Zongo, Oliver; Topham, Christine; Anderson, Richard; Thompson, Elizabeth; Spiro, Nikki; Hodges, Elizabeth; Ellam, Timothy; Bagnall, Alan; Jackson, Ralph; Bridgett, Victoria; Wilson, Peter; Das, Neelanjan; Doulton, Timothy; Loader, David; Hector, Gemma; Levy, Terry; Bent, Clare; Kodoth, Vivek; Horler, Stephanie; Nix, Sara; Robinson, Nicholas; Al-Janabi, Firas; Sayer, Jeremy; Iyer, Sudha Ganesh; Redman, Emily; Ramirez, Jonaifah; Padmanabhan, Sandosh; Sharif, Faisal; Alhmoudi, Aishah; Lunardi, Mattia; Coen, Eileen; Glynn, Nicola; Lauder, Lucas; Kulenthiran, Saarraaken; Koch, Christina; Wachter, Angelika; Schmid, Axel; Kannenkeril, Dennis; Heinritz, Ulrike; Endres-Frohlich, Kerstin; Rommel, Karl Philipp; Fengler, Karl; Petzold, Martin; Büttner, Margit; Weil, Joachim; Agdirlioglu, Tolga; Köllner, Tanja; Stephan, Jeannine; Dagkonakis, Nikolaos; Hamann, Frank; Ettl, Ute; Petzsche, Ulrike; Reimer, Peter; Hausberg, Martin; Hinrichs, Ralf; Di Ponio-Voit, Isabella; Lutz, Matthias; Gosse, Philippe; Cremer, Antoine; Papadopoulos, Panteleimon; Gaudissard, Julie; Maire, Florent; Sapoval, Marc; Livrozet, Marine; Regrag, Asma; Paquet, Valerie; Delsart, Pascal; Hennicaux, Justin; Sommeville, Coralie; Bertrand, Fabien; Lafeber, Melvin; Zeijen, Victor; Ruiter, Amo; van Ramshorst, Jan; Xaplanteris, Panagiotis; Briki, Rachid; de Hemptinne, Quentin; Pascal, Severine; Renard, Katty; Lefebvre, Pascal; Ferdinande, Bert; Iglesias, Juan; Ehret, Georg; Gallego, Laetitia; Dobretz, Kevin |
| Contributors: |
CIC - HEGP (CIC 1418); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou APHP (HEGP); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Université Paris Cité (UPCité) |
| Source: |
ISSN: 2380-6583. |
| Publisher Information: |
CCSD; American Medical Association |
| Publication Year: |
2023 |
| Subject Terms: |
[SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Importance Two 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. Objective To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. Design, Setting, and Participants Sham-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 m 2 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. Interventions Ultrasound renal denervation vs a sham procedure. Main Outcomes and Measures The 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. Results Among 1038 eligible patients, 150 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1001/jama.2023.0713 |
| Availability: |
https://hal.science/hal-04730427; https://hal.science/hal-04730427v1/document; https://hal.science/hal-04730427v1/file/Endovascular%20Ultrasound%20Renal%20Denervation%20to%20Treat%20Hypertension%20-%20PMC.pdf; https://doi.org/10.1001/jama.2023.0713 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.C0599ED5 |
| Database: |
BASE |