Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial

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SURTAVI Trial Investigators, 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 Kleiman, Susheel Kodali, Isaac George, Patrick Teefy, Bob Kiaii, Jae K. Oh, Arie Pieter Kappetein, Yanping Chang, Andrew S. Mugglin & 31 others Michael J. Reardon, 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, Robert Stoler, Robert Hebeler, Kamal Khabbaz, David Scott Lim, Mark Bladergroen, Peter Fail, Edgar Feinberg, Michael Rinaldi, Eric Skipper, Atul Chawla, David Hockmuth, Raj Makkar, Wen Cheng, Janah Aji, Frank Bowen, Theodore Schreiber, Scott Henry, Christian Hengstenberg

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.

Original languageEnglish (US)
Pages (from-to)323-331
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume13
Issue number3
DOIs
StatePublished - Feb 10 2020

PMID: 32029248

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Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial. / SURTAVI Trial Investigators.

In: JACC: Cardiovascular Interventions, Vol. 13, No. 3, 10.02.2020, p. 323-331.

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Harvard

SURTAVI Trial Investigators 2020, 'Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial' JACC: Cardiovascular Interventions, vol. 13, no. 3, pp. 323-331. https://doi.org/10.1016/j.jcin.2019.10.043

APA

SURTAVI Trial Investigators (2020). Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial. JACC: Cardiovascular Interventions, 13(3), 323-331. https://doi.org/10.1016/j.jcin.2019.10.043

Vancouver

SURTAVI Trial Investigators. Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial. JACC: Cardiovascular Interventions. 2020 Feb 10;13(3):323-331. https://doi.org/10.1016/j.jcin.2019.10.043

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SURTAVI Trial Investigators. / Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial. In: JACC: Cardiovascular Interventions. 2020 ; Vol. 13, No. 3. pp. 323-331.

BibTeX

@article{c0673382fb124a5084cb6c24a186237b,
title = "Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial",
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",
author = "{SURTAVI Trial Investigators} and {Van Mieghem}, {Nicolas M.} and Popma, {Jeffrey J.} and Deeb, {G. Michael} and Yakubov, {Steven J.} and Serruys, {Patrick W.} and Stephan Windecker and Lars S{\o}ndergaard and Mubashir Mumtaz and Hemal Gada and Stanley Chetcuti and Neal Kleiman and Susheel Kodali and Isaac George and Patrick Teefy and Bob Kiaii and Oh, {Jae K.} and Kappetein, {Arie Pieter} and Yanping Chang and Mugglin, {Andrew S.} and Reardon, {Michael J.} and Paul Sorajja and Benjamin Sun and Himanshu Agarwal and Thomas Langdon and {den Heijer}, Peter and Mohamed Bentala and Daniel O'Hair and Tanvir Bajwa and Timothy Byrne and Michael Caskey and Basil Paulus and Edward Garrett and Robert Stoler and Robert Hebeler and Kamal Khabbaz and Lim, {David Scott} and Mark Bladergroen and Peter Fail and Edgar Feinberg and Michael Rinaldi and Eric Skipper and Atul Chawla and David Hockmuth and Raj Makkar and Wen Cheng and Janah Aji and Frank Bowen and Theodore Schreiber and Scott Henry and Christian Hengstenberg",
year = "2020",
month = "2",
day = "10",
doi = "10.1016/j.jcin.2019.10.043",
language = "English (US)",
volume = "13",
pages = "323--331",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier",
number = "3",

}

RIS

TY - JOUR

T1 - Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial

AU - SURTAVI Trial Investigators

AU - Van Mieghem, Nicolas M.

AU - Popma, Jeffrey J.

AU - Deeb, G. Michael

AU - Yakubov, Steven J.

AU - Serruys, Patrick W.

AU - Windecker, Stephan

AU - Søndergaard, Lars

AU - Mumtaz, Mubashir

AU - Gada, Hemal

AU - Chetcuti, Stanley

AU - Kleiman, Neal

AU - Kodali, Susheel

AU - George, Isaac

AU - Teefy, Patrick

AU - Kiaii, Bob

AU - Oh, Jae K.

AU - Kappetein, Arie Pieter

AU - Chang, Yanping

AU - Mugglin, Andrew S.

AU - Reardon, Michael J.

AU - Sorajja, Paul

AU - Sun, Benjamin

AU - Agarwal, Himanshu

AU - Langdon, Thomas

AU - den Heijer, Peter

AU - Bentala, Mohamed

AU - O'Hair, Daniel

AU - Bajwa, Tanvir

AU - Byrne, Timothy

AU - Caskey, Michael

AU - Paulus, Basil

AU - Garrett, Edward

AU - Stoler, Robert

AU - Hebeler, Robert

AU - Khabbaz, Kamal

AU - Lim, David Scott

AU - Bladergroen, Mark

AU - Fail, Peter

AU - Feinberg, Edgar

AU - Rinaldi, Michael

AU - Skipper, Eric

AU - Chawla, Atul

AU - Hockmuth, David

AU - Makkar, Raj

AU - Cheng, Wen

AU - Aji, Janah

AU - Bowen, Frank

AU - Schreiber, Theodore

AU - Henry, Scott

AU - Hengstenberg, Christian

PY - 2020/2/10

Y1 - 2020/2/10

N2 - 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.

AB - 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.

KW - aortic stenosis

KW - randomized clinical trial

KW - surgical aortic valve replacement

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85078498995&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85078498995&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2019.10.043

DO - 10.1016/j.jcin.2019.10.043

M3 - Article

VL - 13

SP - 323

EP - 331

JO - JACC: Cardiovascular Interventions

T2 - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 3

ER -

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    Research output: Contribution to journalArticle

ID: 60068618