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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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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. |
format | Online Article Text |
id | pubmed-9615434 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
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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