Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial

Michael Böhm, Kazuomi Kario, David E. Kandzari, Felix Mahfoud, Michael A. Weber, Roland E. Schmieder, Konstantinos Tsioufis, Stuart Pocock, Dimitris Konstantinidis, James W. Choi, Cara East, David P. Lee, Adrian Ma, Sebastian Ewen, Debbie L. Cohen, Robert Wilensky, Chandan M. Devireddy, Janice Lea, Axel Schmid, Joachim WeilTolga Agdirlioglu, Denise Reedus, Brian K. Jefferson, David Reyes, Richard D'Souza, Andrew S.P. Sharp, Faisal Sharif, Martin Fahy, Vanessa DeBruin, Sidney A. Cohen, Sandeep Brar, Raymond R. Townsend, Ertan Akarca, Suhail Allaqaband, Eirini Andrikou, Jiro Aoki, Ahran Arnold, Herbert Aronow, Masahiko Asami, William Bachinsky, John Barton, Kyle Bass, Bryan Batson, Chris Bell, Barry Bertolet, Yvonne Bewarder, Karl Bihlmaier, Christian Binner, Jason Bloom, Benjamin Blossom, Somjot Brar, Angela Brown, Robert Burke, Martin N. Burke, Michael Butler, William Calhoun, James Campbell, Steve Carroll, Neil Chapman, Craig Chasen, Shi Chi Cheng, Beth Chia, Nishit Choksi, Jordana Cohen, Niall Connolly, Johanna Contreras, Ronan Cusack, George Dangas, Shukri David, Justin Davies, Juliane Dederer, Matthew Denker, Udo Desch, Matthaios Didangelos, Thomas Dienemann, Kyriakos Dimitriadis, Jean François Dorval, John Estess, Sarah Fan, Karl Fengler, Lee Ferguson, Marat Fudim, Valentin Fuster, Fidel Garcia, Santiago Garcia, Alex Garton, Carl Gessler, Magdi Ghali, Bharat Gummadi, Amit Gupta, Antonio Gutierrez, Peggy Hardesty, Phillip Hartung, Walter H. Haught, Yonghong Haun, Sara Hays, Wolfgang Helmreich, Douglas Hill, Ingrid Hopper, Yu Horiuchi, Satoshi Hoshide, James Howard, Wanda Ikeda, Fued Jan, Rajiv Jauhar, Desmond Jay, James Johnson, Thomas Johnston, Schuyler Jones, Susanne Jung, Theodoros Kalos, Mihar Kanitkar, Dennis Kannenkeril, Alexandros Kasiakogias, Samer Kazziha, Daniel Keene, Jayant Khitha, Hosei Kikushima, Taisei Kobayashi, Kota Komiyama, Takahiro Komori, John Kotter, Antonios Kouparanis, Joshua Krasnow, Saarraangan Kulenthiran, Sarwan Kumar, Philippe L'Allier, Phillip Laney, Lucas Lauder, Marc A. Lavoie, Matthias Lerche, Elena Linesky, Nelson Little, Carl Lomboy, Jelena Lucic, Philipp Lurz, Shannon Lynch, Prakash Mansukhani, Katie McDuffie, Brian McGrath, Brent McLaurin, Ashley Meade, Perwaiz Meraj, Dominic Millenaar, Naing Moore, Fumiko Mori, Phillip Munch, James Murphy, Jennifer Murray, Aravinda Nanjundappa, Kai Ninomiya, Yusuke Oba, Tim O'Connor, Yukiyo Ogata, Yukako Ogoyama, Rachel Onsrud, Christian Ott, Bimal Padaliya, Neha Pagidipati, Manesh Patel, Kiritkumar Patel, Emanouela Petteinidou, Wendy Porr, Anjani Rao, Rabia Razi, Christopher Regan, Michael Remetz, David Rizik, Monique Robison, Karl Philipp Rommel, Liesbeth Rosseel, Marcos Rothstein, Randolph Rough, Jose Saavedra, Souhell Saba, Robert Schwartz, Shaun Selcer, Sayan Sen, Jacqueline Sennott, Ramin Shadman, Samit Shah, Douglas Shemin, Hayato Shimizu, Masahisa Shimpo, Mehdi Shishehbor, Matthew Shun-Shin, Francisco Sierra, Jasvindar Singh, Avneet Singh, Yassir Sirajeldin, Nedaa Skeik, George Soliman, Sarah Statton, Julia Stehli, Susan Steigerwalt, Kristina Striepe, Jason Stuck, Markus Suppan, Laura Svetkey, Ganpat Takker, Kengo Tanabe, Tetsu Tanaka, Daijiro Tomii, Sabino Torre, Jay Traverse, Crystal Tyson, Alejandro Vasquez, Enrique Velasquez, Sreekanth Vemulapalli, Hirotaka Waki, Tony Walton, Yale Wang, Thomas Weber, Bryan Wells, Robert Wilkins, Thomas Wright, Kazuyuki Yahagi, Alan Yeung, Ray Zadegan, Thomas Zeller, Khaled Ziada, Antonios Ziakas, David Zidar

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Abstract

Background: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. Methods: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. Findings: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was −3·9 mm Hg (Bayesian 95% credible interval −6·2 to −1·6) and for office systolic blood pressure the difference was −6·5 mm Hg (−9·6 to −3·5). No major device-related or procedural-related safety events occurred up to 3 months. Interpretation: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. Funding: Medtronic.

Original languageEnglish
Pages (from-to)1444-1451
Number of pages8
JournalThe Lancet
Volume395
Issue number10234
DOIs
StatePublished - May 2 2020

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