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Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation

OBJECTIVES: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years. METHODS: In a multicentre, phase III, pragmatic, double-blind, randomiz...

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Autores principales: Sharples, Linda D, Mills, Christine, Chiu, Yi-Da, Fynn, Simon, Holcombe, Helen M, Nashef, Samer A M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9615434/
https://www.ncbi.nlm.nih.gov/pubmed/35348642
http://dx.doi.org/10.1093/ejcts/ezac181
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author Sharples, Linda D
Mills, Christine
Chiu, Yi-Da
Fynn, Simon
Holcombe, Helen M
Nashef, Samer A M
author_facet Sharples, Linda D
Mills, Christine
Chiu, Yi-Da
Fynn, Simon
Holcombe, Helen M
Nashef, Samer A M
author_sort Sharples, Linda D
collection PubMed
description OBJECTIVES: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years. METHODS: In a multicentre, phase III, pragmatic, double-blind, randomized controlled superiority trial, cardiac surgery patients with >3 months of AF were randomized 1:1 to adjunct AF surgery or control. Primary outcomes of 1-year SR restoration and 2-year quality-adjusted survival were already reported. This study reports on rhythm, survival, quality-adjusted survival, stroke, medication and safety to 5 years. RESULTS: Between 2009 and 2014, 352 patients were randomized. By 5 years 79 died, 58 withdrew, 34 were lost to follow-up and the remaining 182 provided data. AF surgery significantly increased the odds of remaining in SR at 5 years {odds ratio = 2.98 [95% confidence interval (CI) 1.23, 7.17], P = 0.015}. There was a non-significant decrease in stroke incidence [odds ratio = 0.605 (95% CI 0.284, 1.287), P = 0.19], but no improved survival [5-year survival: AF surgery 77.3% (95% CI 71.1%, 83.5%), controls 77.8% (95% CI 71.7%, 84.0%), P = 0.85]. Quality-adjusted survival difference was negligible (−0.03; 95% CI −0.33, 0.27, P = 0.85). The composite of survival free of stroke and AF was better in the AF surgery group [odds ratio = 2.34 (95% CI 1.03, 5.31)]. There were no other differences. CONCLUSIONS: Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN82731440.
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spelling pubmed-96154342022-11-01 Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation Sharples, Linda D Mills, Christine Chiu, Yi-Da Fynn, Simon Holcombe, Helen M Nashef, Samer A M Eur J Cardiothorac Surg General Adult Cardiac OBJECTIVES: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years. METHODS: In a multicentre, phase III, pragmatic, double-blind, randomized controlled superiority trial, cardiac surgery patients with >3 months of AF were randomized 1:1 to adjunct AF surgery or control. Primary outcomes of 1-year SR restoration and 2-year quality-adjusted survival were already reported. This study reports on rhythm, survival, quality-adjusted survival, stroke, medication and safety to 5 years. RESULTS: Between 2009 and 2014, 352 patients were randomized. By 5 years 79 died, 58 withdrew, 34 were lost to follow-up and the remaining 182 provided data. AF surgery significantly increased the odds of remaining in SR at 5 years {odds ratio = 2.98 [95% confidence interval (CI) 1.23, 7.17], P = 0.015}. There was a non-significant decrease in stroke incidence [odds ratio = 0.605 (95% CI 0.284, 1.287), P = 0.19], but no improved survival [5-year survival: AF surgery 77.3% (95% CI 71.1%, 83.5%), controls 77.8% (95% CI 71.7%, 84.0%), P = 0.85]. Quality-adjusted survival difference was negligible (−0.03; 95% CI −0.33, 0.27, P = 0.85). The composite of survival free of stroke and AF was better in the AF surgery group [odds ratio = 2.34 (95% CI 1.03, 5.31)]. There were no other differences. CONCLUSIONS: Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN82731440. Oxford University Press 2022-03-26 /pmc/articles/PMC9615434/ /pubmed/35348642 http://dx.doi.org/10.1093/ejcts/ezac181 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle General Adult Cardiac
Sharples, Linda D
Mills, Christine
Chiu, Yi-Da
Fynn, Simon
Holcombe, Helen M
Nashef, Samer A M
Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title_full Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title_fullStr Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title_full_unstemmed Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title_short Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
title_sort five-year results of amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation
topic General Adult Cardiac
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9615434/
https://www.ncbi.nlm.nih.gov/pubmed/35348642
http://dx.doi.org/10.1093/ejcts/ezac181
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