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Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial

BACKGROUND AND AIMS: Bayesian analyses can provide additional insights into the results of clinical trials, aiding in the decision-making process. We analysed the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia (SURVIVE-VT) trial using Bayesian survival mod...

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Autores principales: Ávila, Pablo, Berruezo, Antonio, Jiménez-Candil, Javier, Tercedor, Luis, Calvo, David, Arribas, Fernando, Fernández-Portales, Javier, Merino, José Luis, Hernández-Madrid, Antonio, Fernández-Avilés, Francisco, Arenal, Ángel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10326301/
https://www.ncbi.nlm.nih.gov/pubmed/37366571
http://dx.doi.org/10.1093/europace/euad181
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author Ávila, Pablo
Berruezo, Antonio
Jiménez-Candil, Javier
Tercedor, Luis
Calvo, David
Arribas, Fernando
Fernández-Portales, Javier
Merino, José Luis
Hernández-Madrid, Antonio
Fernández-Avilés, Francisco
Arenal, Ángel
author_facet Ávila, Pablo
Berruezo, Antonio
Jiménez-Candil, Javier
Tercedor, Luis
Calvo, David
Arribas, Fernando
Fernández-Portales, Javier
Merino, José Luis
Hernández-Madrid, Antonio
Fernández-Avilés, Francisco
Arenal, Ángel
author_sort Ávila, Pablo
collection PubMed
description BACKGROUND AND AIMS: Bayesian analyses can provide additional insights into the results of clinical trials, aiding in the decision-making process. We analysed the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia (SURVIVE-VT) trial using Bayesian survival models. METHODS AND RESULTS: The SURVIVE-VT trial randomized patients with ischaemic cardiomyopathy and monomorphic ventricular tachycardia (VT) to catheter ablation or antiarrhythmic drugs (AAD) as a first-line strategy. The primary outcome was a composite of cardiovascular death, appropriate implantable cardioverter–defibrillator shocks, unplanned heart failure hospitalizations, or severe treatment-related complications. We used informative, skeptical, and non-informative priors with different probabilities of large effects to compute the posterior distributions using Markov Chain Monte Carlo methods. We calculated the probabilities of hazard ratios (HR) being <1, <0.9, and <0.75, as well as 2-year survival estimates. Of the 144 randomized patients, 71 underwent catheter ablation and 73 received AAD. Regardless of the prior, catheter ablation had a >98% probability of reducing the primary outcome (HR < 1) and a >96% probability of achieving a reduction of >10% (HR < 0.9). The probability of a >25% (HR < 0.75) reduction of treatment-related complications was >90%. Catheter ablation had a high probability (>93%) of reducing incessant/slow undetected VT/electric storm, unplanned hospitalizations for ventricular arrhythmias, and overall cardiovascular admissions > 25%, with absolute differences of 15.2%, 21.2%, and 20.2%, respectively. CONCLUSION: In patients with ischaemic cardiomyopathy and VT, catheter ablation as a first-line therapy resulted in a high probability of reducing several clinical outcomes compared to AAD. Our study highlights the value of Bayesian analysis in clinical trials and its potential for guiding treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03734562
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spelling pubmed-103263012023-07-08 Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial Ávila, Pablo Berruezo, Antonio Jiménez-Candil, Javier Tercedor, Luis Calvo, David Arribas, Fernando Fernández-Portales, Javier Merino, José Luis Hernández-Madrid, Antonio Fernández-Avilés, Francisco Arenal, Ángel Europace Clinical Research BACKGROUND AND AIMS: Bayesian analyses can provide additional insights into the results of clinical trials, aiding in the decision-making process. We analysed the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia (SURVIVE-VT) trial using Bayesian survival models. METHODS AND RESULTS: The SURVIVE-VT trial randomized patients with ischaemic cardiomyopathy and monomorphic ventricular tachycardia (VT) to catheter ablation or antiarrhythmic drugs (AAD) as a first-line strategy. The primary outcome was a composite of cardiovascular death, appropriate implantable cardioverter–defibrillator shocks, unplanned heart failure hospitalizations, or severe treatment-related complications. We used informative, skeptical, and non-informative priors with different probabilities of large effects to compute the posterior distributions using Markov Chain Monte Carlo methods. We calculated the probabilities of hazard ratios (HR) being <1, <0.9, and <0.75, as well as 2-year survival estimates. Of the 144 randomized patients, 71 underwent catheter ablation and 73 received AAD. Regardless of the prior, catheter ablation had a >98% probability of reducing the primary outcome (HR < 1) and a >96% probability of achieving a reduction of >10% (HR < 0.9). The probability of a >25% (HR < 0.75) reduction of treatment-related complications was >90%. Catheter ablation had a high probability (>93%) of reducing incessant/slow undetected VT/electric storm, unplanned hospitalizations for ventricular arrhythmias, and overall cardiovascular admissions > 25%, with absolute differences of 15.2%, 21.2%, and 20.2%, respectively. CONCLUSION: In patients with ischaemic cardiomyopathy and VT, catheter ablation as a first-line therapy resulted in a high probability of reducing several clinical outcomes compared to AAD. Our study highlights the value of Bayesian analysis in clinical trials and its potential for guiding treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03734562 Oxford University Press 2023-06-27 /pmc/articles/PMC10326301/ /pubmed/37366571 http://dx.doi.org/10.1093/europace/euad181 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. 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 Clinical Research
Ávila, Pablo
Berruezo, Antonio
Jiménez-Candil, Javier
Tercedor, Luis
Calvo, David
Arribas, Fernando
Fernández-Portales, Javier
Merino, José Luis
Hernández-Madrid, Antonio
Fernández-Avilés, Francisco
Arenal, Ángel
Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title_full Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title_fullStr Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title_full_unstemmed Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title_short Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial
title_sort bayesian analysis of the substrate ablation vs. antiarrhythmic drug therapy for symptomatic ventricular tachycardia trial
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10326301/
https://www.ncbi.nlm.nih.gov/pubmed/37366571
http://dx.doi.org/10.1093/europace/euad181
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