| Autor: |
Yale Wang, Matthaios Didangelos, John Kotter, Christopher Bell, Perwaiz Meraj, Naing Moore, Shaun Selcer, Samer Kazziha, Fidel Garcia, Neha J. Pagidipati, Ashley Meade, Benjamin Blossom, Kota Komiyama, Walter H. Haught, Marat Fudim, Markus Suppan, A.M. Gutiérrez, Chandan Devireddy, Karl Philipp Rommel, Thomas C. Wright, Ronan Cusack, Daniel Keene, Richard D'Souza, Jayant Khitha, Fued Jan, Joshua Krasnow, Magdi Ghali, James W. Choi, Kiritkumar Patel, Santiago Garcia, Fumiko Mori, Joachim Weil, Peggy Hardesty, Kai Ninomiya, Michael Böhm, Kengo Tanabe, Christian Binner, Thomas Dienemann, Kristina Striepe, Somjot S Brar, Michael Remetz, Shi Chi Cheng, Robert E. Burke, Valentin Fuster, Shannon Lynch, Vanessa DeBruin, Tim O'Connor, Aravinda Nanjundappa, Kazuyuki Yahagi, Alex Garton, Rajiv Jauhar, David Rizik, Monique Robison, Wendy Porr, Craig Chasen, Sayan Sen, Stuart J. Pocock, Sreekanth Vemulapalli, Philipp Lurz, Phillip Hartung, Udo Desch, Nishit Choksi, Neil Chapman, Adrian Ma, Anjani Rao, Marc A. Lavoie, Janice P. Lea, Shukri David, Taisei Kobayashi, Robert S. Schwartz, William J. Calhoun, Tony Walton, John Estess, Theodoros Kalos, Avneet Singh, Tetsu Tanaka, Robert L. Wilensky, Cara East, Sandeep Brar, Katie McDuffie, Jasvindar Singh, James R. Murphy, Robert Wilkins, Antonios Ziakas, Beth Chia, Jordana B. Cohen, Samit Shah, Debbie L. Cohen, Wolfgang Helmreich, Jason Stuck, Masahiko Asami, Satoshi Hoshide, Sarah Statton, Yusuke Oba, Sarwan Kumar, Lucas Lauder, Yukiyo Ogata, Thomas Zeller, Alejandro Arias Vasquez, Yu Horiuchi, Susanne Jung, Tolga Agdirlioglu, Matthew G. Denker, David Reyes, Denise Reedus, Jay H. Traverse, Sidney Cohen, George Soliman, Mehdi H. Shishehbor, Douglas Hill, Yukako Ogoyama, Faisal Sharif, Matthew J. Shun-Shin, Martin N. Burke, Yassir Sirajeldin, Saarraangan Kulenthiran, Elena Linesky, Hirotaka Waki, Niall Connolly, Dominic Millenaar, Yvonne Bewarder, Sabino Torre, David E. Kandzari, Carl Lomboy, Desmond Jay, Rabia Razi, Christian Ott, William Bachinsky, Roland E. Schmieder, Thomas Weber, Bryan Wells, Konstantinos Tsioufis, John H. Barton, George Dangas, Philippe L. L’Allier, Bimal Padaliya, Bharat Gummadi, Jacqueline Sennott, Antonios Kouparanis, Johanna Contreras, Bryan Batson, Jason Bloom, James P. Howard, Douglas Shemin, Sara Hays, Kyle Bass, Mihar Kanitkar, Liesbeth Rosseel, Nedaa Skeik, James Campbell, Juliane Dederer, Brent T. McLaurin, Steve Carroll, Marcos Rothstein, Emanouela Petteinidou, Jean François Dorval, Souhell Saba, David A. Zidar, Thomas Johnston, Axel Schmid, Randolph Rough, Phillip Munch, Masahisa Shimpo, Hayato Shimizu, James R. Johnson, Alan C. Yeung, Brian K. Jefferson, Karl Bihlmaier, Dimitris Konstantinidis, Felix Mahfoud, Francisco Sierra, Raymond R. Townsend, Kazuomi Kario, Jose M. Saavedra, Suhail Allaqaband, Carl Gessler, Jennifer M. Murray, Ingrid Hopper, Wanda Ikeda, Crystal C. Tyson, Ertan Akarca, Ray Zadegan, Jelena Lucic, Ahran D. Arnold, Laura P. Svetkey, Matthias Lerche, Ganpat Takker, Christopher Regan, Dennis Kannenkeril, Enrique Velasquez, Martin Fahy, Kyriakos Dimitriadis, Justin E. Davies, Yonghong Haun, Takahiro Komori, David P. Lee, Hosei Kikushima, Rachel Onsrud, Jiro Aoki, Eirini Andrikou, Sebastian Ewen, Susan Steigerwalt, Khaled M. Ziada, Amit Gupta, Herbert D. Aronow, Michael Butler, Phillip Laney, Michael A. Weber, Andrew S.P. Sharp, Schuyler Jones, Manesh R. Patel, Prakash Mansukhani, Daijiro Tomii, Lee Ferguson, Karl Fengler, Julia Stehli, Brian McGrath, Nelson Little, Ramin Shadman, Barry Bertolet, Sarah Fan, Alexandros Kasiakogias, Angela L. Brown |
| Rok vydání: |
2020 |
| Předmět: |
|
| Zdroj: |
Lancet (London, England). 395(10234) |
| ISSN: |
1474-547X |
| Popis: |
Summary 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
