Accès ouvert déclaré
2023
article
Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications
David E. Kandzari, Raymond R. Townsend, Kazuomi Kario, Felix Mahfoud, Michael A. Weber, Roland E. Schmieder, Stuart Pocock, Konstantinos Tsioufis, D. Konstantinidis, James W. Choi, Cara East, Lucas Lauder, Debbie L. Cohen, Taisei Kobayashi, Axel Schmid, David P. Lee, Adrian Ma, Joachim Weil, Tolga Agdirlioglu, Markus P. Schlaich, Sharad Shetty, Chandan Devireddy, Janice P. Lea, Jiro Aoki, Andrew S.P. Sharp, Richard Anderson, Martin Fahy, Vanessa DeBruin, Sandeep Brar, Michael Böhm, Yale Wang, Desmond Jay, Brent McLaurin, Carl Lomboy, Suhail Allaqaband, Fuad Jan, Bharat Gummadi, Marc R. Litt, Fidel Garcia, Jasvindar Singh, Angela L. Brown, Ashley Paul, James Coulson, Aravinda Nanjundappa, Ganpat G. Thakker, James Campbell, Benjamin Honton, Bruno Farah, Manesh R. Patel, Antonio Gutiérrez, Crystal C. Tyson, Laura P. Svetkey, Marat Fudim, Neha J. Pagidipati, Schuyler Jones, Sreekanth Vemulapalli, Ambar Kulshreshtha, Bryan J. Wells, Bryan Batson, Robert B. Wilkins, Faisal Sharif, Abdullahi Mohamed Khair, Abhishek Wilson Pallippattu, Aishah Alhmoudi, Brian Gaffney, Christian Cawley, Colin Gorry, Hanan Hamed, Jennifer Carron, John Birrane, Liesbeth Rosseel, Mattia Lunardi, Michael J. Cronin, Myles McKittrick, Naeif Almagal, Noman Khalid, Shirjeel Shahzad, Simone Fezzi, Stanislav Tyulkin, Sanjit S. Jolly, Gordon Yip, Jon-David Schwalm, Michael Tsang, Shamir R. Mehta, Philipp Lurz, Christian Binner, Danilo Obradović, Florian Fahr, Ines Richter, Johannes Rotta detto Loria, Karl Fengler, Karl‐Philipp Rommel, Mateo Marin‐Cuartas, Matthias Lerche, Philipp Hartung, Phillip Münch, Robert Höllriegel, Silke John, Satoru Otsuji, Hirofumi Kusumoto, Hiroto Tamaru, Kasumi Ishibuchi, Katsuyuki Hasegawa, Ken Sugimoto, Mikio Kakishita, Rui Ishii, Shin Takiuchi, Shingo Yasuda, Sho Nakabayashi, Wataru Yamamoto, Yorihiko Higashino, Yuji Shimatani, Yusuke Taniguchi, Alexandros Kasiakogias, E. Andrikou, Κωνσταντίνος Κωνσταντίνου, Kyriakos Dimitriadis, Theodoros Kalos, Garvey Rene, Jordana B. Cohen, Maria Bonanni, Matthew G. Denker, Robert Wilensky, Tai Kobayashi, Venkatesh Y. Anjan, Yonghong Huan, Walter Herbert Haught, Joshua Krasnow, Alejandro Arias Vásquez, C. Gessler, Christopher Roth, David Drenning, Enrique M. Velasquez, George Soliman, James E. Murphy, Kaushik K. Jain, Michael Butler, Mihir Kanitkar, Phillip Laney, Ross J. Hunter, Shi-Chi Cheng, Thomas C. Wright, Neil Chapman, Ahran Arnold, Alexandra N. Nowbar, Azara Janmohamed, Ben Corden, Christopher Cook, Christopher Rajkumar, Daniel Keene, David Thompson, Henry Seligman, James P. Howard, Justin E. Davies, Mark Sweeney, Matthew Shun‐Shin, Michael Foley, Nicholas M. Quaife, Rasha Al‐Lamee, Savvas Hadjiphilippou, Sayan Sen, Yousif Ahmad, Hayato Shimizu, Hirotaka Waki, Keisuke Narita, Masahisa Shimpo, Satoshi Hoshide, Takahiro Komori, Yukako Ogoyama, Yukiyo Ogata, Yusuke Oba, Anton Lishmanov, Travis Jeffords, Magdi Ghali, Beth Chia, Rachel Onsrud, Randolph Rough, Daijiro Tomii, Fumiko Mori, Hosei Kikushima, Kai Ninomiya, Kazuyuki Yahagi, Kengo Tanabe, Kôsuke Nakamura, Kota Komiyama, Masaaki Nakase, Masahiko Asami, Naoto Setoguchi, Tetsu Tanaka, Yu Horiuchi, Yusuke Watanabe, Dmitriy N. Feldman, Geoffrey Bergman, Ines Sherifi, Luke Kim, Nivee Amin, Robert M. Minutello, S. Chiu Wong, Stephen McCullough, Richard D’Souza, Hibba Kurdi, Sarah Statton, Tony Watkinson, Barry Bertolet, Amit Gupta, Benjamin Blossom, Chris Bell, D.C. Hill, Francisco Sierra, James G. Johnson, J. Murray Estess, Joseph P. Adams, Katie McDuffie, Lee Ferguson, Nelson Little, Richard Dane Ballard, Roger A. Williams, Wanda Ikeda, William J. Calhoun, William L. Carroll, Avneet Singh, Benjamin J. Hirsh, Perwaiz Meraj, Rajiv Jauhar, Harsh Golwala, Jose Rueda, Kellie Graham, Ramsey Al-Hakim, Robert Rope, Dariush Bahrami, Denise Reedus, Shukri David, Iram Rehman, Nishit Choksi, Samer Kazziha, Sarwan Kumar, Souheil Saba, Susan Steigerwalt, Yassir Sirajeldin, Omar Hyder, Herbert D. Aronow, Andrea Connors, Douglas Shemin, Clare Bent, Terry Levy, Vivek Kodoth, Márcio Galindo Kiuchi, Revathy Carnagarin, Sabino R. Torre, Howard Levitt, Lin Chen, Sarah Fan, Sergio Waxman, Wendy Porr, George Mangos, Brendan Smyth, Cathie Lane, Mark Sader, Kirit Patel, Anjani Rao, Brett Milford, Guneet Ahluwalia, Justin Field, Nihar Jena, Stacy Loree, John Graham, Abdul Al‐Hesayen, Akshay Bagai, Junya Shite, Amane Kozuki, Atsushi Suzuki, Eri Masuko, Fumitaka Soga, Hiroyuki Asada, Hiroyuki Shibata, Ryoji Nagoshi, Ryudo Fujiwara, Shokan Kyo, Tomohiro Miyata, Yoichi Kijima, Lukas Hafer, Rene-Alexander Starick, Sebastian Keil, Udo Desch, Shigeru Saito, Eiji Koyama, Futoshi Yamanaka, Hiroaki Yokoyama, Kazuki Tobita, Koki Shishido, Masashi Yamaguchi, Masato Murakami, Noriaki Moriyama, Saeko Takahashi, Shingo Mizuno, Shohei Yokota, Takahiro Hayashi, Takashi Yamada, Tamiharu Yamagishi, Yoichi Sugiyama, Yuka Mashimo, Yusuke Tamaki, Yutaka Tanaka, David Lee, Alan C. Yeung, Thomas Noel, Ernesto Umaña, John Katopodis, William C. Dixon, Tony Walton, Adam Rischin, Adrian J. Y. Chee, Alexandra Leaney, Himavan Fernando, Ingrid Hopper, Jason Bloom, Jessica Fairley, Julia Stehli, Julian Segan, Meenal Sharma, M Fitzgerald, Michelle Papandony, Naomi Whyler, Samer Noaman, S. K. Noushad Ali, Brian Jefferson, David Reyes‐Leiva, Thomas Johnston, Alexander Höfling, Ann-Kathrin Berger, Bodo Cremers, Dominic Millenaar, Ina Živanović, Jelena Lučić, Juliane Dederer, Patrick Fischer, Saarraangan Kulenthiran, Sebastian Ewen, Yvonne Bewarder, Agnes Bosch, Christian Ott, Dennis Kannenkeril, Ertan Akarca, Iris Kistner, Julie Kolwelter, Karl Bihlmaier, Kristina Striepe, Marina V. Karg, Merve Günes-Altan, Stefanie Friedrich, Susanne Jung, Thomas Dienemann, Antonios Ziakas, Antonios Κouparanis, Areti Pagiantza, Emmanouela Peteinidou, Matthaios Didagelos, Mehdi H. Shishehbor, Ashley Meade, Elena Linetsky, Monique Robinson, John Kotter, Khaled M. Ziada, William Bachinsky, Alex Garton, Jason Stuck, Vasilios Papademetriou, Annise Chung, Ping Li, Sameer Nagpal, Michael S. Remetz, Samit Shah, Shannon E. Lynch
121Citations signalées, ce qui n’est pas une note de qualité
19Institutions déclarées
6Pays d’affiliation déclarés
Rattachement africain : us, jp, de, gb, gr, au.
Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications
- Date Crossref
- 01/11/2023
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Les institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Les sujets associés
Blood Pressure and Hypertension StudiesChronic Kidney Disease and DiabetesSodium Intake and Health