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

Author:

Ávila Pablo1ORCID,Berruezo Antonio2ORCID,Jiménez-Candil Javier3ORCID,Tercedor Luis4ORCID,Calvo David56ORCID,Arribas Fernando7ORCID,Fernández-Portales Javier8ORCID,Merino José Luis9ORCID,Hernández-Madrid Antonio10,Fernández-Avilés Francisco1ORCID,Arenal Ángel1ORCID

Affiliation:

1. Cardiology Department, Hospital General Universitario Gregorio Marañón, IiSGM, Universidad Complutense, CIBERCV , Dr Esquerdo 46, 28007, Madrid , Spain

2. Arrhythmia Unit, Cardiology Department, Hospital Clinic and Teknon Medical Centre , c/Villarroel 170, 08036, Barcelona , Spain

3. Arrhythmia Unit, Cardiology Department, IBSAL-Hospital Universitario, Universidad de Salamanca, CIBERCV , Paseo San Vicente 58-182, 37007, Salamanca , Spain

4. Arrhythmia Unit, Cardiology Department, Hospital Universitario Virgen de las Nieves , Avd. Fuerzas Armadas 2, 18014, Granada , Spain

5. Arrhythmia Unit, Cardiology Department, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA) , Avd Roma, s/n, 33011, Oviedo , Spain

6. Arrhythmia Unit, Cardiology Department, Hospital Clínico San Carlos , Prof Martín Lagos, S/N, Madrid, 28040 , Spain

7. Cardiology Department, Hospital Doce de Octubre , Av. de Córdoba, s/n, 28041, Madrid , Spain

8. Cardiology Department, Complejo Hospitalario Universitario de Cáceres , Av. de la Universidad 75, 10004, Cáceres , Spain

9. Arrhythmia Unit, Cardiology Department, Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma , P.º de la Castellana 261, 28046, Madrid , Spain

10. Arrhythmia Unit, Hospital Ramón y Cajal, Universidad de Alcalá de Henares , M-607, 9, 100, 28034, Madrid , Spain

Abstract

Abstract 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

Funder

Instituto de Salud Carlos III

Ministerio de Ciencia e Innovación

European Regional Development Fund

Biosense Webster

Publisher

Oxford University Press (OUP)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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