Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications Journal Articles uri icon

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abstract

  • 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).

authors

  • Kandzari, David E
  • Townsend, Raymond R
  • Kario, Kazuomi
  • Mahfoud, Felix
  • Weber, Michael A
  • Schmieder, Roland E
  • Pocock, Stuart
  • Tsioufis, Konstantinos
  • Konstantinidis, Dimitrios
  • Choi, James
  • East, Cara
  • Lauder, Lucas
  • Cohen, Debbie L
  • Kobayashi, Taisei
  • Schmid, Axel
  • Lee, David P
  • Ma, Adrian
  • Weil, Joachim
  • Agdirlioglu, Tolga
  • Schlaich, Markus P
  • Shetty, Sharad
  • Devireddy, Chandan M
  • Lea, Janice
  • Aoki, Jiro
  • Sharp, Andrew SP
  • Anderson, Richard
  • Fahy, Martin
  • DeBruin, Vanessa
  • Brar, Sandeep
  • Böhm, Michael
  • Wang, Yale
  • Jay, Desmond
  • McLaurin, Brent
  • Lomboy, Carl
  • Allaqaband, Suhail
  • Jan, Fuad
  • Gummadi, Bharat
  • Litt, Marc
  • Garcia, Fidel
  • Singh, Jasvindar
  • Brown, Angela
  • Choi, James
  • Paul, Ashley
  • Sharp, Andrew
  • Coulson, James
  • Nanjundappa, Aravinda
  • Thakker, Ganpat
  • Campbell, James
  • Honton, Benjamin
  • Farah, Bruno
  • Patel, Manesh
  • Gutierrez, Antonio
  • Tyson, Crystal
  • Svetkey, Laura
  • Fudim, Marat
  • Pagidipati, Neha
  • Jones, Schuyler
  • Vemulapalli, Sreekanth
  • Devireddy, Chandan
  • Kulshreshtha, Ambar
  • Wells, Bryan
  • Lea, Janice
  • Batson, Bryan
  • Wilkins, Robert
  • Sharif, Faisal
  • Khair, Abdullahi Mohamed
  • Pallippattu, Abhishek Wilson
  • Alhmoudi, Aishah Matar
  • Gaffney, Brian
  • Cawley, Christian
  • Gorry, Colin
  • Hamed, Hanan
  • Carron, Jennifer
  • Birrane, John
  • Rosseel, Liesbeth
  • Lunardi, Mattia
  • Cronin, Michael
  • McKittrick, Myles
  • Almagal, Naeif
  • Khalid, Noman
  • Shehahd, Qussai
  • Shahzad, Shirjeel
  • Fezzi, Simone
  • Tyulkin, Stanislav
  • Bel, Xavier Armario
  • Jolly, Sanjit
  • Yip, Gordon
  • Schwalm, Jon-david
  • Tsang, Michael
  • Mehta, Shamir
  • Lurz, Philipp C
  • Binner, Christian
  • Obradovic, Danilo
  • Fahr, Florian
  • Richter, Ines
  • Rotta detto Loria, Johannes
  • Fengler, Karl
  • Rommel, Karl-Philipp
  • Cuartas, Mateo Marin
  • Lerche, Matthias
  • Hartung, Philipp
  • Münch, Phillip
  • Höllriegel, Robert
  • John, Silke
  • Otsuji, Satoru
  • Kusumoto, Hirofumi
  • Tamaru, Hiroto
  • Ishibuchi, Kasumi
  • Hasegawa, Katsuyuki
  • Sugimoto, Ken
  • Kakishita, Mikio
  • Ishii, Rui
  • Takiuchi, Shin
  • Yasuda, Shingo
  • Nakabayashi, Sho
  • Yamamoto, Wataru
  • Higashino, Yorihiko
  • Shimatani, Yuji
  • Taniguchi, Yusuke
  • Tsioufis, Konstantinos
  • Kasiakogias, Alexandros
  • Konstantinidis, Dimitris
  • Andrikou, Eirini
  • Konstantinou, Konstantinos
  • Dimitriadis, Kyriakos
  • Kalos, Theodoros
  • Cohen, Debbie
  • Rene, Garvey
  • Cohen, Jordana
  • Bonanni, Maria
  • Denker, Matthew
  • Wickramisinghe, Rasi
  • Wilensky, Robert
  • Kobayashi, Tai
  • Anjan, Venkatesh
  • Huan, Yonghong
  • Haught, Walter Herbert
  • Krasnow, Joshua
  • Vasquez, Alejandro
  • Gessler, Carl
  • Roth, Christopher
  • Drenning, David
  • Velasquez, Enrique
  • Soliman, George
  • Murphy, James
  • Jain, Kaushik
  • Butler, Michael
  • Kanitkar, Mihir
  • Laney, Phillip
  • Hunter, Ross
  • Cheng, Shi-Chi
  • Wright, Thomas
  • Haught, Walter Herbert
  • Chapman, Neil
  • Arnold, Ahran
  • Nowbar, Alexandra
  • Janmohamed, Azara
  • Corden, Ben
  • Cook, Christopher
  • Rajkumar, Christopher
  • Keene, Daniel
  • Thompson, David
  • Seligman, Henry
  • Howard, James
  • Davies, Justin
  • Sweeney, Mark
  • Shun-Shin, Matthew
  • Foley, Michael
  • Quaife, Nicholas
  • Al-Lamee, Rasha
  • Hadjiphilippou, Savvas
  • Sen, Sayan
  • Ahmad, Yousif
  • Kario, Kazuomi
  • Shimizu, Hayato
  • Waki, Hirotaka
  • Narita, Keisuke
  • Shimpo, Masahisa
  • Hoshide, Satoshi
  • Komori, Takahiro
  • Ogoyama, Yukako
  • Ogata, Yukiyo
  • Oba, Yusuke
  • Bisharat, Mohanned
  • Lishmanov, Anton
  • Bisharat, Mohanned
  • Jeffords, Travis
  • Ghali, Magdi
  • Chia, Beth
  • Onsrud, Rachel
  • Rough, Randolph
  • Aoki, Jiro
  • Tomii, Daijiro
  • Mori, Fumiko
  • Kikushima, Hosei
  • Ninomiya, Kai
  • Yahagi, Kazuyuki
  • Tanabe, Kengo
  • Nakamura, Kosuke
  • Komiyama, Kota
  • Nakase, Masaaki
  • Asami, Masahiko
  • Setoguchi, Naoto
  • Tanaka, Tetsu
  • Horiuchi, Yu
  • Watanabe, Yusuke
  • Feldman, Dmitriy
  • Bergman, Geoffrey
  • Sherifi, Ines
  • Kim, Luke
  • Amin, Nivee
  • Minutello, Robert
  • Wong, S Chiu
  • McCullough, Stephen
  • D'Souza, Richard
  • Sharp, Andrew
  • Kurdi, Hibba
  • D'Souza, Richard
  • Statton, Sarah
  • Watkinson, Tony
  • Bertolet, Barry
  • Gupta, Amit
  • Blossom, Benjamin
  • Bell, Chris
  • Hill, Douglas
  • Sierra, Francisco
  • Johnson, James
  • Estess, John
  • Adams, Joseph
  • McDuffie, Katie
  • Ferguson, Lee
  • Little, Nelson
  • Ballard, Richard Dane
  • Williams, Roger
  • Ikeda, Wanda
  • Calhoun, William
  • Carroll, William
  • Singh, Avneet
  • Hirsh, Benjamin
  • Meraj, Perwaiz
  • Jauhar, Rajiv
  • Golwala, Harsh
  • Rueda, Jose
  • Graham, Kellie
  • Al-Hakim, Ramsey
  • Rope, Robert
  • Kandzari, David
  • Bahrami, Dariush
  • Reedus, Denise
  • David, Shukri
  • Rehman, Iram
  • Zakaria, Khalid
  • Choksi, Nishit
  • Kazziha, Samer
  • Kumar, Sarwan
  • Saba, Souheil
  • Steigerwalt, Susan
  • Sirajeldin, Yassir
  • Hyder, Omar
  • Aronow, Herbert
  • Connors, Andrea
  • Shemin, Douglas
  • Bent, Clare
  • Levy, Terry
  • Kodoth, Vivek
  • Schlaich, Markus
  • Kiuchi, Marcio
  • Carnagarin, Revathy
  • Shetty, Sharad
  • Torre, Sabino
  • Levitt, Howard
  • Chen, Lin
  • Fan, Sarah
  • Waxman, Sergio
  • Porr, Wendy
  • Mangos, George
  • Smyth, Brendan
  • Lane, Cathie
  • Sader, Mark
  • Patel, Kirit Kumar
  • Rao, Anjani
  • Milford, Brett
  • Ahluwalia, Guneet
  • Sennott, Jaqueline
  • Field, Justin
  • Jena, Nihar
  • Loree, Stacy
  • Graham, John
  • Al-Hesayen, Abdul
  • Bagai, Akshay
  • Shite, Junya
  • Kozuki, Amane
  • Suzuki, Atsushi
  • Masuko, Eri
  • Soga, Fumitaka
  • Asada, Hiroyuki
  • Shibata, Hiroyuki
  • Nagoshi, Ryoji
  • Fujiwara, Ryudo
  • Kyo, Shokan
  • Miyata, Tomohiro
  • Kijima, Yoichi
  • Weil, Joachim
  • Griesinger, Lena
  • Hafer, Lukas
  • Starick, Rene-Alexander
  • Keil, Sebastian
  • Agdirlioglu, Tolga
  • Desch, Udo
  • Saito, Shigeru
  • Koyama, Eiji
  • Yamanaka, Futoshi
  • Yokoyama, Hiroaki
  • Tobita, Kazuki
  • Shishido, Koki
  • Yamaguchi, Masashi
  • Murakami, Masato
  • Moriyama, Noriaki
  • Takahashi, Saeko
  • Mizuno, Shingo
  • Yokota, Shohei
  • Hayashi, Takahiro
  • Yamada, Takashi
  • Yamagishi, Tamiharu
  • Sugiyama, Yoichi
  • Mashimo, Yuka
  • Tamaki, Yusuke
  • Tanaka, Yutaka
  • Lee, David
  • Ma, Adrian
  • Yeung, Alan
  • Noel, Thomas
  • Umana, Ernesto
  • Katopodis, John
  • Dixon, William
  • Walton, Tony
  • Rischin, Adam
  • Chee, Adrian
  • Leaney, Alexandra
  • Fernando, Himavan
  • Hopper, Ingrid
  • Bloom, Jason
  • Fairley, Jessica
  • Stehli, Julia
  • Segan, Julian
  • Sharma, Meenal
  • Fitzgerald, Melissa
  • Papandony, Michelle
  • Whyler, Naomi
  • Noaman, Samer
  • Ali, Shazeea
  • Jefferson, Brian
  • Reyes, David
  • Johnston, Thomas
  • Böhm, Michael
  • Höfling, Alexander
  • Berger, Ann-Kathrin
  • Cremers, Bodo
  • Millenaar, Dominic
  • Mahfoud, Felix
  • Zivanovic, Ina
  • Lucic, Jelena
  • Dederer, Juliane
  • Lauder, Lucas
  • Fischer, Patrick
  • Kulenthiran, Saarraangan
  • Ewen, Sebastian
  • Bewarder, Yvonne
  • Schmieder, Roland
  • Bosch, Agnes
  • Schmid, Axel
  • Ott, Christian
  • Kannenkeril, Dennis
  • Akarca, Ertan
  • Kistner, Iris
  • Kolwelter, Julie
  • Bihlmaier, Karl
  • Striepe, Kristina
  • Karg, Marina
  • Günes-Altan, Merve
  • Anna Friedrich, Stefanie Sofia
  • Jung, Susanne
  • Dienemann, Thomas
  • Ziakas, Antonios
  • Kouparanis, Antonios
  • Pagiantza, Areti
  • Peteinidou, Emmanouela
  • Didagelos, Matthaios
  • Psochias, Polykarpos Akis
  • Shishehbor, Mehdi
  • Meade, Ashley
  • Linetsky, Elena
  • Robinson, Monique
  • Kotter, John
  • Ziada, Khaled
  • Kotter, John
  • Bachinsky, William
  • Garton, Alex
  • Stuck, Jason
  • Papademetriou, Vasilios
  • Chung, Annise
  • Li, Ping
  • Nagpal, Sameer
  • Remetz, Michael
  • Shah, Samit
  • Lynch, Shannon

publication date

  • November 2023