Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial
2020; Elsevier BV; Volume: 395; Issue: 10234 Linguagem: Inglês
10.1016/s0140-6736(20)30554-7
ISSN1474-547X
AutoresMichael Böhm, Kazuomi Kario, David E. Kandzari, Felix Mahfoud, Michael A. Weber, Roland E. Schmieder, Konstantinos Tsioufis, Stuart J. Pocock, D. Konstantinidis, James W. Choi, Cara East, David P. Lee, Adrian Ma, Sebastian Ewen, Debbie L. Cohen, Robert Wilensky, Chandan Devireddy, Janice P. Lea, Axel Schmid, Joachim Weil, Tolga Agdirlioglu, Denise Reedus, Brian Jefferson, David Reyes‐Leiva, 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, E. Andrikou, Jiro Aoki, Ahran Arnold, Herbert D. 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 L. Brown, Robert E. Burke, Martin Burke, Michael Butler, William J. Calhoun, James Campbell, Steve Carroll, Neil Chapman, Craig A. Chasen, Shi-Chi Cheng, Beth Chia, Nishit Choksi, Jordana B. Cohen, Niall Connolly, Johanna Contreras, Ronan Cusack, George Dangas, Shukri David, Justin E. Davies, Juliane Dederer, Matthew G. Denker, Udo Desch, Matthaios Didangelos, Thomas Dienemann, Kyriakos Dimitriadis, Jean-François Dorval, John Estess, Sarah Fan, Karl Fengler, Lee Ferguson, Marat Fudim, Valentı́n Fuster, Fidel Garcia, Santiago Garcia, Alex Garton, C. Gessler, Magdi Ghali, Bharat Gummadi, Amit Gupta, Antonio Gutiérrez, Peggy Hardesty, Phillip Hartung, Walter Herbert Haught, Yonghong Haun, Sara Hays, Wolfgang Helmreich, D.C. Hill, Ingrid Hopper, Yu Horiuchi, Satoshi Hoshide, James P. Howard, Wanda Ikeda, Fued Jan, Rajiv Jauhar, Desmond Jay, James G. 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 Κouparanis, Joshua Krasnow, Saarraangan Kulenthiran, Sarwan Kumar, Philippe L. L’Allier, Phillip Laney, Lucas Lauder, Marc Andre Lavoie, Matthias Lerche, Elena Linesky, Nelson Little, Carl Lomboy, Jelena Lučić, Philipp Lurz, Shannon E. Lynch, Prakash Mansukhani, Katie McDuffie, Brian McGrath, Brent McLaurin, Ashley Meade, Perwaiz Meraj, Dominic Millenaar, Naing Moore, Fumiko Mori, Phillip Münch, James E. Murphy, Jennifer Murray, Aravinda Nanjundappa, Kai Ninomiya, Yusuke Oba, Tim O'Connor, Yukiyo Ogata, Yukako Ogoyama, Rachel Onsrud, Christian Ott, Bimal Padaliya, Neha J. Pagidipati, Manesh R. Patel, Kiritkumar Patel, Emanouela Petteinidou, Wendy Porr, Anjani Rao, Rabia Razi, Christopher Regan, Michael S. Remetz, David G. Rizik, Monique Robison, Karl‐Philipp Rommel, Liesbeth Rosseel, Marcos Rothstein, Randolph Rough, José M. Saavedra, Souhell Saba, Robert S. Schwartz, Shaun Selcer, Sayan Sen, Jacqueline Sennott, Ramin Shadman, Samit Shah, Douglas Shemin, Hayato Shimizu, Masahisa Shimpo, Mehdi H. 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 P. Svetkey, Ganpat Takker, Kengo Tanabe, Tetsu Tanaka, Daijiro Tomii, Sabino R. Torre, Jay H. Traverse, Crystal C. Tyson, Alejandro Arias Väsquez, Enrique M. Velasquez, Sreekanth Vemulapalli, Hirotaka Waki, Tony Walton, Yale Wang, Thomas Weber, Bryan Wells, Robert B. Wilkins, Thomas Wright, Kazuyuki Yahagi, Alan C. Yeung, Ray Zadegan, Thomas Zeller, Khaled M. Ziada, Antonios Ziakas, David Zidar,
Tópico(s)Hemodynamic Monitoring and Therapy
ResumoCatheter-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.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.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.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.Medtronic.
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