Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

作者：David E. Kandzari, Raymond R. Townsend, Kazuomi Kario, Felix Mahfoud, Michael A. Weber, Roland Erich Schmieder, Stuart Pocock, Konstantinos P Tsioufis, D. Konstantinidis, James W. Choi, Cara Anne East, Lucas Lauder, Debbie L. Cohen, Taisei Kobayashi, Axel Schmid, David P. Lee, Adrian Ma, Joachim Weil, Tolga Agdirlioglu, Markus Peter Schlaich, Sharad V. Shetty, Chandan M. Devireddy, Janice P. Lea, Jiro Aoki, Andrew S.P. Sharp, Richard Anthony Anderson, Martin P. Fahy, Vanessa DeBruin, Sandeep Kaur Brar, Michael C Böhm, Yale Wang, Desmond B. Jay, Brent T. McLaurin, Carl Lomboy, Suhail Q. Allaqaband, Fuad Jan, Bharat Gummadi, Marc R. Litt, Fidel Garcia, Jasvindar Singh, Angela L. Brown, James W. Choi, Ashley M. Paul, Andrew S.P. Sharp, James Coulson, Aravinda Nanjundappa, Ganpat G. Thakker, James Ian Campbell, Benjamin Honton, Bruno Farah, Manesh R. Patel, Antonio Gutiérrez, Crystal C. Tyson, Laura P. Svetkey, Marat Fudim, Neha Jadeja Pagidipati, Schuyler Jones, Sreekanth Vemulapalli, Chandan M. Devireddy, Ambar Kulshreshtha, Bryan J. Wells, Janice P. Lea, 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 P. Birrane, Liesbeth Rosseel, Mattia Lunardi, Michael John Cronin, Myles McKittrick, Naeif Almagal, Noman Khalid, Qussai Shehahd, Shirjeel Shahzad, Simone Fezzi, Stanislav Tyulkin, Xavier Armario Bel, Sanjit S. Jolly, Gordon Yip, Jon-David Schwalm, Michael Tsang, Shamir R. Mehta, Philipp C. Lurz, Christian Binner, Danilo D. 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, Konstantinos P Tsioufis, Alexandros Kasiakogias, Dimitris Konstantinidis, Eirini Andrikou, Konstantinos Konstantinou, Kyriakos S. Dimitriadis, Theodoros Kalos, Debbie L. Cohen, Garvey Rene, Jordana B. Cohen, Maria Bonanni, Matthew G. Denker, Rasi Wickramisinghe, Robert Wilensky, Tai Kobayashi, Venkatesh Y. Anjan, Yonghong Huan, Walter Herbert Haught, Joshua M. Krasnow, Alejandro Arias Vásquez, C. Gessler, Christopher Roth, David Drenning, Enrique M. Velasquez, George Soliman, James E. J. Murphy, Kaushik K. Jain, Michael D. Butler, Mihir Kanitkar, Phillip Laney, Ross Jacob Hunter, Shi-Chi Cheng, Thomas C. Wright, Walter Herbert Haught, Neil Chapman, Ahran D. Arnold, Alexandra N. Nowbar, Azara Janmohamed, Ben Corden, Christopher Cook, Christopher Rajkumar, Daniel Keene, David M Thompson, Henry Seligman, James P. Howard, Justin E. Davies, Mark D. Sweeney, Matthew James Shun-Shin, Michael J. Foley, Nicholas M. Quaife, Rasha Kadem Al-Lamee, Savvas Hadjiphilippou, Sayan Sen, Yousif Ahmad, Kazuomi Kario, Hayato Shimizu, Hirotaka Waki, Keisuke Narita, Masahisa Shimpo, Satoshi Hoshide, Takahiro Komori, Yukako Ogoyama, Yukiyo Ogata, Yusuke Oba, Mohanned Bisharat, Anton Lishmanov, Mohanned Bisharat, Travis Jeffords, Magdi G.H. Ghali, Beth Chia, Rachel Onsrud, Randolph Rough, Jiro Aoki, 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 W. Bergman, Ines Sherifi, Luke Kim, Nivee P. Amin, Robert M. Minutello, S. Chiu Wong, Stephen McCullough, Richard J D'Souza, Andrew S.P. Sharp, Hibba Kurdi, Richard J D'Souza, Sarah A. Statton, Tony Watkinson, Barry D. Bertolet, Amit Gupta, Benjamin Blossom, Chris Bell, Douglas C. Hill, Francisco Sierra, James Gibb 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 B. Golwala, Jose F. Rueda, Kellie Graham, Ramsey A. Al-Hakim, Robert W. Rope, David E. Kandzari, Dariush Bahrami, Denise Reedus, Shukri W. David, Iram Rehman, Khalid Zakaria, Nishit Choksi, Samer Kazziha, Sarwan Kumar, Souheil E. Saba, Susan Patricia Steigerwalt, Yassir Sirajeldin, Omar N. Hyder, Herbert D. Aronow, Andrea Connors, Douglas G. Shemin, Clare Louise Bent, Terry Levy, VIVEK N. KODOTH, Markus Peter Schlaich, Márcio Galindo Kiuchi, Revathy Carnagarin, Sharad V. Shetty, Sabino R. Torre, Howard L. Levitt, Lin Chen, Sarah Fan, Sergio Waxman, Wendy Porr, George Mangos, Brendan J Smyth, Cathie Lane, Mark A. Sader, Kirit Patel, Anjani Rao, Brett Milford, Guneet Ahluwalia, Jaqueline Sennott, Justin S. Field, Nihar Kanta Jena, Stacy Loree, John Joseph 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, Joachim Weil, Lena Griesinger, Lukas Hafer, Rene-Alexander Starick, Sebastian Keil, Tolga Agdirlioglu, 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, Adrian Ma, Alan C. Yeung, Thomas E. Noel, Ernesto Umaña, John Katopodis, William C. Dixon, Tony Walton, Adam Rischin, Adrian J. Y. Chee, Alexandra Leaney, Himavan Fernando, Ingrid Hopper, Jason E. Bloom, Jessica L. Fairley, Julia Stehli, Julian Segan, Meenal Sharma, Melissa Fitzgerald, Michelle Papandony, Naomi Whyler, Samer Q. Noaman, S. K. Noushad Ali, Brian Keith Jefferson, David Reyes‐Leiva, Thomas Johnston, Michael C Böhm, Alexander Höfling, Ann-Kathrin Berger, Bodo Cremers, Dominic Millenaar, Felix Mahfoud, Ina Živanović, Jelena Lučić, Juliane Dederer, Lucas Lauder, Patrick Fischer, Saarraangan Kulenthiran, Sebastian Ewen, Yvonne Bewarder, Roland Erich Schmieder, Agnes Bosch, Axel Schmid, 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, Polykarpos Akis Psochias, Mehdi H. Shishehbor, Ashley M. Meade, Elena Linetsky, Monique R. Robinson, John R. Kotter, Khaled M. Ziada, John R. Kotter, William Bachinsky, Alex Garton, Jason Stuck, Vasilios Papademetriou, Annise Chung, Ping Li, Sameer Nagpal, Michael S. Remetz, Samit Shah, Shannon E. Lynch · 发表于：Journal of the American College of Cardiology · 年份：2023 · DOI：10.1016/j.jacc.2023.08.045 · 被引用次数：121 · 研究领域：Blood Pressure and Hypertension Studies、Chronic Kidney Disease and Diabetes、Sodium Intake and Health

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...