Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial
Nicolas M Van Mieghem, Jeffrey J Popma, G Michael Deeb, Steven J Yakubov, Patrick W Serruys, Stephan Windecker, Lars Søndergaard, Mubashir Mumtaz, Hemal Gada, Stanley Chetcuti, Neal S Kleiman, Susheel Kodali, Isaac George, Patrick Teefy, Bob Kiaii, Jae K Oh, Arie Pieter Kappetein, Yanping Chang, Andrew S Mugglin, Michael J Reardon, SURTAVI Trial Investigators, Paul Sorajja, Benjamin Sun, Himanshu Agarwal, Thomas Langdon, Peter den Heijer, Mohamed Bentala, Daniel O'Hair, Tanvir Bajwa, Timothy Byrne, Michael Caskey, Basil Paulus, Edward Garrett Jr, Robert Stoler, Robert Hebeler, Jeffrey J Popma, Kamal Khabbaz, David Scott Lim, Mark Bladergroen, Peter Fail, Edgar Feinberg 2nd, Michael Rinaldi, Eric Skipper, Atul Chawla, David Hockmuth, Raj Makkar, Wen Cheng, Susheel Kodali, Isaac George, Janah Aji, Frank Bowen, Theodore Schreiber, Scott Henry, Christian Hengstenberg, Sabine Bleiziffer, J Kevin Harrison, Chad Hughes, James Joye, Vincent Gaudiani, Vasilis Babaliaros, Vinod Thourani, Nicolas van Mieghem, A Pieter Kappetein, Harold Dauerman, Joseph Schmoker, Kimberly Skelding, Alfred Casale, Jan Kovac, Tomasz Spyt, Puvi Seshiah, J Michael Smith, Raymond McKay, Robert Hagberg, Ray Matthews, Vaughn Starnes, William O'Neill, Gaetano Paone, Jose Maria Hernandez García, Miguel Such, Cesar Morís de la Tassa, Juan Carlos Llosa Cortina, Stephan Windecker, Thierry Carrel, Brian Whisenant, John Doty, Jon Resar, John Conte, Vicken Aharonian, Thomas Pfeffer, Andreas Rück, Matthias Corbascio, Daniel Blackman, Pankaj Kaul, Chad Kliger, Derek Brinster, Patrick Teefy, Bob Kiaii, Ferdinand Leya, Mamdouh Bakhos, Gurpreet Sandhu, Alberto Pochettino, Nicolo Piazza, Benoit de Varennes, Ad van Boven, Piet Boonstra, Ron Waksman, Ammar Bafi, Anita Asgar, Raymond Cartier, Robert Kipperman, John Brown, Lang Lin, Joshua Rovin, Samin Sharma, David Adams, Stanley Katz, Alan Hartman, Hasanian Al-Jilaihawi, Mathew Williams, Juan Crestanello, Scott Lilly, Mohammad Ghani, Robert Mark Bodenhamer, Vivek Rajagopal, James Kauten, Mumbashir Mumtaz, Williams Bachinsky, Georg Nickenig, Armin Welz, Lars Søndergaard, Peter Skov Olsen, Steven Yakubov, Daniel Watson, Adnan Chhatriwalla, Keith Allen, Paul Teirstein, Jeffrey Tyner, Paul Mahoney, Joseph Newton, William Merhi, John Keiser, Alan Yeung, Craig Miller, Jurriën Ten Berg, Robin Heijmen, George Petrossian, Newell Robinson, Stephen Brecker, Marjan Jahangiri, Thomas Davis, Sanjay Batra, James Hermiller, David Heimansohn, Sam Radhakrishnan, Stephen Fremes, Brijeshwar Maini, Brian Bethea, David Brown, William Ryan, Michael Reardon, Neal Kleiman, Christian Spies, Jeffrey Lau, Howard Herrmann, Joseph Bavaria, Eric Horlick, Chris Feindel, Franz-Josef Neumann, Friedhelm Beyersdorf, Roland Binder, Francesco Maisano, Marco Costa, Alan Markowitz, Peter Tadros, George Zorn 3rd, Eduardo de Marchena, Tomas Salerno, Stanley Chetcuti, G Michael Deeb, Marino Labinz, Marc Ruel, Joon Sup Lee, Thomas Gleason, Frederick Ling, Peter Knight, Mark Robbins, Stephen Ball, John Giacomini, Thomas Burdon, Robert Applegate, Neal Kon, Richard Schwartz, Scott Schubach, John Forrest, Abeel Mangi, Nicolas M Van Mieghem, Jeffrey J Popma, G Michael Deeb, Steven J Yakubov, Patrick W Serruys, Stephan Windecker, Lars Søndergaard, Mubashir Mumtaz, Hemal Gada, Stanley Chetcuti, Neal S Kleiman, Susheel Kodali, Isaac George, Patrick Teefy, Bob Kiaii, Jae K Oh, Arie Pieter Kappetein, Yanping Chang, Andrew S Mugglin, Michael J Reardon, SURTAVI Trial Investigators, Paul Sorajja, Benjamin Sun, Himanshu Agarwal, Thomas Langdon, Peter den Heijer, Mohamed Bentala, Daniel O'Hair, Tanvir Bajwa, Timothy Byrne, Michael Caskey, Basil Paulus, Edward Garrett Jr, Robert Stoler, Robert Hebeler, Jeffrey J Popma, Kamal Khabbaz, David Scott Lim, Mark Bladergroen, Peter Fail, Edgar Feinberg 2nd, Michael Rinaldi, Eric Skipper, Atul Chawla, David Hockmuth, Raj Makkar, Wen Cheng, Susheel Kodali, Isaac George, Janah Aji, Frank Bowen, Theodore Schreiber, Scott Henry, Christian Hengstenberg, Sabine Bleiziffer, J Kevin Harrison, Chad Hughes, James Joye, Vincent Gaudiani, Vasilis Babaliaros, Vinod Thourani, Nicolas van Mieghem, A Pieter Kappetein, Harold Dauerman, Joseph Schmoker, Kimberly Skelding, Alfred Casale, Jan Kovac, Tomasz Spyt, Puvi Seshiah, J Michael Smith, Raymond McKay, Robert Hagberg, Ray Matthews, Vaughn Starnes, William O'Neill, Gaetano Paone, Jose Maria Hernandez García, Miguel Such, Cesar Morís de la Tassa, Juan Carlos Llosa Cortina, Stephan Windecker, Thierry Carrel, Brian Whisenant, John Doty, Jon Resar, John Conte, Vicken Aharonian, Thomas Pfeffer, Andreas Rück, Matthias Corbascio, Daniel Blackman, Pankaj Kaul, Chad Kliger, Derek Brinster, Patrick Teefy, Bob Kiaii, Ferdinand Leya, Mamdouh Bakhos, Gurpreet Sandhu, Alberto Pochettino, Nicolo Piazza, Benoit de Varennes, Ad van Boven, Piet Boonstra, Ron Waksman, Ammar Bafi, Anita Asgar, Raymond Cartier, Robert Kipperman, John Brown, Lang Lin, Joshua Rovin, Samin Sharma, David Adams, Stanley Katz, Alan Hartman, Hasanian Al-Jilaihawi, Mathew Williams, Juan Crestanello, Scott Lilly, Mohammad Ghani, Robert Mark Bodenhamer, Vivek Rajagopal, James Kauten, Mumbashir Mumtaz, Williams Bachinsky, Georg Nickenig, Armin Welz, Lars Søndergaard, Peter Skov Olsen, Steven Yakubov, Daniel Watson, Adnan Chhatriwalla, Keith Allen, Paul Teirstein, Jeffrey Tyner, Paul Mahoney, Joseph Newton, William Merhi, John Keiser, Alan Yeung, Craig Miller, Jurriën Ten Berg, Robin Heijmen, George Petrossian, Newell Robinson, Stephen Brecker, Marjan Jahangiri, Thomas Davis, Sanjay Batra, James Hermiller, David Heimansohn, Sam Radhakrishnan, Stephen Fremes, Brijeshwar Maini, Brian Bethea, David Brown, William Ryan, Michael Reardon, Neal Kleiman, Christian Spies, Jeffrey Lau, Howard Herrmann, Joseph Bavaria, Eric Horlick, Chris Feindel, Franz-Josef Neumann, Friedhelm Beyersdorf, Roland Binder, Francesco Maisano, Marco Costa, Alan Markowitz, Peter Tadros, George Zorn 3rd, Eduardo de Marchena, Tomas Salerno, Stanley Chetcuti, G Michael Deeb, Marino Labinz, Marc Ruel, Joon Sup Lee, Thomas Gleason, Frederick Ling, Peter Knight, Mark Robbins, Stephen Ball, John Giacomini, Thomas Burdon, Robert Applegate, Neal Kon, Richard Schwartz, Scott Schubach, John Forrest, Abeel Mangi
Abstract
Objectives: The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis.
Background: Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated.
Methods: The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients.
Results: The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference; Bayesian credible interval: -5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences.
Conclusions: The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.
Keywords: aortic stenosis; randomized clinical trial; surgical aortic valve replacement; transcatheter aortic valve replacement.
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed