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 Weil; Tolga 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

doi:10.1016/S0140-6736(20)30554-7

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

Internal Medicine

Research output: Contribution to journal › Article › peer-review

376 Scopus citations

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 language	English (US)
Pages (from-to)	1444-1451
Number of pages	8
Journal	The Lancet
Volume	395
Issue number	10234
DOIs	https://doi.org/10.1016/S0140-6736(20)30554-7
State	Published - May 2 2020

ASJC Scopus subject areas

General Medicine

Access to Document

10.1016/S0140-6736(20)30554-7

Cite this

Böhm, M., Kario, K., Kandzari, D. E., Mahfoud, F., Weber, M. A., Schmieder, R. E., Tsioufis, K., Pocock, S., Konstantinidis, D., Choi, J. W., East, C., Lee, D. P., Ma, A., Ewen, S., Cohen, D. L., Wilensky, R., Devireddy, C. M., Lea, J., Schmid, A., ... Zidar, D. (2020). Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. The Lancet, 395(10234), 1444-1451. https://doi.org/10.1016/S0140-6736(20)30554-7

Böhm, M, Kario, K, Kandzari, DE, Mahfoud, F, Weber, MA, Schmieder, RE, Tsioufis, K, Pocock, S, Konstantinidis, D, Choi, JW, East, C, Lee, DP, Ma, A, Ewen, S, Cohen, DL, Wilensky, R, Devireddy, CM, Lea, J, Schmid, A, Weil, J, Agdirlioglu, T, Reedus, D, Jefferson, BK, Reyes, D, D'Souza, R, Sharp, ASP, Sharif, F, Fahy, M, DeBruin, V, Cohen, SA, Brar, S, Townsend, RR, Akarca, E, Allaqaband, S, Andrikou, E, Aoki, J, Arnold, A, Aronow, H, Asami, M, Bachinsky, W, Barton, J, Bass, K, Batson, B, Bell, C, Bertolet, B, Bewarder, Y, Bihlmaier, K, Binner, C, Bloom, J, Blossom, B, Brar, S, Brown, A, Burke, R, Burke, MN, Butler, M, Calhoun, W, Campbell, J, Carroll, S, Chapman, N, Chasen, C, Cheng, SC, Chia, B, Choksi, N, Cohen, J, Connolly, N, Contreras, J, Cusack, R, Dangas, G, David, S, Davies, J, Dederer, J, Denker, M, Desch, U, Didangelos, M, Dienemann, T, Dimitriadis, K, Dorval, JF, Estess, J, Fan, S, Fengler, K, Ferguson, L, Fudim, M, Fuster, V, Garcia, F, Garcia, S, Garton, A, Gessler, C, Ghali, M, Gummadi, B, Gupta, A, Gutierrez, A, Hardesty, P, Hartung, P, Haught, WH, Haun, Y, Hays, S, Helmreich, W, Hill, D, Hopper, I, Horiuchi, Y, Hoshide, S, Howard, J, Ikeda, W, Jan, F, Jauhar, R, Jay, D, Johnson, J, Johnston, T, Jones, S, Jung, S, Kalos, T, Kanitkar, M, Kannenkeril, D, Kasiakogias, A, Kazziha, S, Keene, D, Khitha, J, Kikushima, H, Kobayashi, T, Komiyama, K, Komori, T, Kotter, J, Kouparanis, A, Krasnow, J, Kulenthiran, S, Kumar, S, L'Allier, P, Laney, P, Lauder, L, Lavoie, MA, Lerche, M, Linesky, E, Little, N, Lomboy, C, Lucic, J, Lurz, P, Lynch, S, Mansukhani, P, McDuffie, K, McGrath, B, McLaurin, B, Meade, A, Meraj, P, Millenaar, D, Moore, N, Mori, F, Munch, P, Murphy, J, Murray, J, Nanjundappa, A, Ninomiya, K, Oba, Y, O'Connor, T, Ogata, Y, Ogoyama, Y, Onsrud, R, Ott, C, Padaliya, B, Pagidipati, N, Patel, M, Patel, K, Petteinidou, E, Porr, W, Rao, A, Razi, R, Regan, C, Remetz, M, Rizik, D, Robison, M, Rommel, KP, Rosseel, L, Rothstein, M, Rough, R, Saavedra, J, Saba, S, Schwartz, R, Selcer, S, Sen, S, Sennott, J, Shadman, R, Shah, S, Shemin, D, Shimizu, H, Shimpo, M, Shishehbor, M, Shun-Shin, M, Sierra, F, Singh, J, Singh, A, Sirajeldin, Y, Skeik, N, Soliman, G, Statton, S, Stehli, J, Steigerwalt, S, Striepe, K, Stuck, J, Suppan, M, Svetkey, L, Takker, G, Tanabe, K, Tanaka, T, Tomii, D, Torre, S, Traverse, J, Tyson, C, Vasquez, A, Velasquez, E, Vemulapalli, S, Waki, H, Walton, T, Wang, Y, Weber, T, Wells, B, Wilkins, R, Wright, T, Yahagi, K, Yeung, A, Zadegan, R, Zeller, T, Ziada, K, Ziakas, A & Zidar, D 2020, 'Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial', The Lancet, vol. 395, no. 10234, pp. 1444-1451. https://doi.org/10.1016/S0140-6736(20)30554-7

@article{a495893eb61545dbbca54cfb0e101286,

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

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.",

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

note = "Publisher Copyright: {\textcopyright} 2020 Elsevier Ltd",

year = "2020",

month = may,

day = "2",

doi = "10.1016/S0140-6736(20)30554-7",

language = "English (US)",

volume = "395",

pages = "1444--1451",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier Limited",

number = "10234",

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TY - JOUR

T1 - Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal)

T2 - a multicentre, randomised, sham-controlled trial

AU - Böhm, Michael

AU - Kario, Kazuomi

AU - Kandzari, David E.

AU - Mahfoud, Felix

AU - Weber, Michael A.

AU - Schmieder, Roland E.

AU - Tsioufis, Konstantinos

AU - Pocock, Stuart

AU - Konstantinidis, Dimitris

AU - Choi, James W.

AU - East, Cara

AU - Lee, David P.

AU - Ma, Adrian

AU - Ewen, Sebastian

AU - Cohen, Debbie L.

AU - Wilensky, Robert

AU - Devireddy, Chandan M.

AU - Lea, Janice

AU - Schmid, Axel

AU - Weil, Joachim

AU - Agdirlioglu, Tolga

AU - Reedus, Denise

AU - Jefferson, Brian K.

AU - Reyes, David

AU - D'Souza, Richard

AU - Sharp, Andrew S.P.

AU - Sharif, Faisal

AU - Fahy, Martin

AU - DeBruin, Vanessa

AU - Cohen, Sidney A.

AU - Brar, Sandeep

AU - Townsend, Raymond R.

AU - Akarca, Ertan

AU - Allaqaband, Suhail

AU - Andrikou, Eirini

AU - Aoki, Jiro

AU - Arnold, Ahran

AU - Aronow, Herbert

AU - Asami, Masahiko

AU - Bachinsky, William

AU - Barton, John

AU - Bass, Kyle

AU - Batson, Bryan

AU - Bell, Chris

AU - Bertolet, Barry

AU - Bewarder, Yvonne

AU - Bihlmaier, Karl

AU - Binner, Christian

AU - Bloom, Jason

AU - Blossom, Benjamin

AU - Brar, Somjot

AU - Brown, Angela

AU - Burke, Robert

AU - Burke, Martin N.

AU - Butler, Michael

AU - Calhoun, William

AU - Campbell, James

AU - Carroll, Steve

AU - Chapman, Neil

AU - Chasen, Craig

AU - Cheng, Shi Chi

AU - Chia, Beth

AU - Choksi, Nishit

AU - Cohen, Jordana

AU - Connolly, Niall

AU - Contreras, Johanna

AU - Cusack, Ronan

AU - Dangas, George

AU - David, Shukri

AU - Davies, Justin

AU - Dederer, Juliane

AU - Denker, Matthew

AU - Desch, Udo

AU - Didangelos, Matthaios

AU - Dienemann, Thomas

AU - Dimitriadis, Kyriakos

AU - Dorval, Jean François

AU - Estess, John

AU - Fan, Sarah

AU - Fengler, Karl

AU - Ferguson, Lee

AU - Fudim, Marat

AU - Fuster, Valentin

AU - Garcia, Fidel

AU - Garcia, Santiago

AU - Garton, Alex

AU - Gessler, Carl

AU - Ghali, Magdi

AU - Gummadi, Bharat

AU - Gupta, Amit

AU - Gutierrez, Antonio

AU - Hardesty, Peggy

AU - Hartung, Phillip

AU - Haught, Walter H.

AU - Haun, Yonghong

AU - Hays, Sara

AU - Helmreich, Wolfgang

AU - Hill, Douglas

AU - Hopper, Ingrid

AU - Horiuchi, Yu

AU - Hoshide, Satoshi

AU - Howard, James

AU - Ikeda, Wanda

AU - Jan, Fued

AU - Jauhar, Rajiv

AU - Jay, Desmond

AU - Johnson, James

AU - Johnston, Thomas

AU - Jones, Schuyler

AU - Jung, Susanne

AU - Kalos, Theodoros

AU - Kanitkar, Mihar

AU - Kannenkeril, Dennis

AU - Kasiakogias, Alexandros

AU - Kazziha, Samer

AU - Keene, Daniel

AU - Khitha, Jayant

AU - Kikushima, Hosei

AU - Kobayashi, Taisei

AU - Komiyama, Kota

AU - Komori, Takahiro

AU - Kotter, John

AU - Kouparanis, Antonios

AU - Krasnow, Joshua

AU - Kulenthiran, Saarraangan

AU - Kumar, Sarwan

AU - L'Allier, Philippe

AU - Laney, Phillip

AU - Lauder, Lucas

AU - Lavoie, Marc A.

AU - Lerche, Matthias

AU - Linesky, Elena

AU - Little, Nelson

AU - Lomboy, Carl

AU - Lucic, Jelena

AU - Lurz, Philipp

AU - Lynch, Shannon

AU - Mansukhani, Prakash

AU - McDuffie, Katie

AU - McGrath, Brian

AU - McLaurin, Brent

AU - Meade, Ashley

AU - Meraj, Perwaiz

AU - Millenaar, Dominic

AU - Moore, Naing

AU - Mori, Fumiko

AU - Munch, Phillip

AU - Murphy, James

AU - Murray, Jennifer

AU - Nanjundappa, Aravinda

AU - Ninomiya, Kai

AU - Oba, Yusuke

AU - O'Connor, Tim

AU - Ogata, Yukiyo

AU - Ogoyama, Yukako

AU - Onsrud, Rachel

AU - Ott, Christian

AU - Padaliya, Bimal

AU - Pagidipati, Neha

AU - Patel, Manesh

AU - Patel, Kiritkumar

AU - Petteinidou, Emanouela

AU - Porr, Wendy

AU - Rao, Anjani

AU - Razi, Rabia

AU - Regan, Christopher

AU - Remetz, Michael

AU - Rizik, David

AU - Robison, Monique

AU - Rommel, Karl Philipp

AU - Rosseel, Liesbeth

AU - Rothstein, Marcos

AU - Rough, Randolph

AU - Saavedra, Jose

AU - Saba, Souhell

AU - Schwartz, Robert

AU - Selcer, Shaun

AU - Sen, Sayan

AU - Sennott, Jacqueline

AU - Shadman, Ramin

AU - Shah, Samit

AU - Shemin, Douglas

AU - Shimizu, Hayato

AU - Shimpo, Masahisa

AU - Shishehbor, Mehdi

AU - Shun-Shin, Matthew

AU - Sierra, Francisco

AU - Singh, Jasvindar

AU - Singh, Avneet

AU - Sirajeldin, Yassir

AU - Skeik, Nedaa

AU - Soliman, George

AU - Statton, Sarah

AU - Stehli, Julia

AU - Steigerwalt, Susan

AU - Striepe, Kristina

AU - Stuck, Jason

AU - Suppan, Markus

AU - Svetkey, Laura

AU - Takker, Ganpat

AU - Tanabe, Kengo

AU - Tanaka, Tetsu

AU - Tomii, Daijiro

AU - Torre, Sabino

AU - Traverse, Jay

AU - Tyson, Crystal

AU - Vasquez, Alejandro

AU - Velasquez, Enrique

AU - Vemulapalli, Sreekanth

AU - Waki, Hirotaka

AU - Walton, Tony

AU - Wang, Yale

AU - Weber, Thomas

AU - Wells, Bryan

AU - Wilkins, Robert

AU - Wright, Thomas

AU - Yahagi, Kazuyuki

AU - Yeung, Alan

AU - Zadegan, Ray

AU - Zeller, Thomas

AU - Ziada, Khaled

AU - Ziakas, Antonios

AU - Zidar, David

PY - 2020/5/2

Y1 - 2020/5/2

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85083822944&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85083822944&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(20)30554-7

DO - 10.1016/S0140-6736(20)30554-7

M3 - Article

C2 - 32234534

AN - SCOPUS:85083822944

SN - 0140-6736

VL - 395

SP - 1444

EP - 1451

JO - The Lancet

JF - The Lancet

IS - 10234

ER -

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

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