Dataset Information

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

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.

SUBMITTER: Avila P

PROVIDER: S-EPMC10326301 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Ávila Pablo P Berruezo Antonio A Jiménez-Candil Javier J Tercedor Luis L Calvo David D Arribas Fernando F Fernández-Portales Javier J Merino José Luis JL Hernández-Madrid Antonio A Fernández-Avilés Francisco F Arenal Ángel Á

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20230701 7

<h4>Background and aims</h4>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.<h4>Methods and results</h4>The SURVIVE-VT trial randomized patients with ischaemic cardiomyopathy and monomorphic ventricular tachycardia (VT) to catheter ablation or antiarrhythmic drugs ...[more]

PMID: 37366571

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Project description:AimsAlthough several studies have proved that repeat catheter ablation is beneficial to recurrent atrial tachycardia (AT)/atrial fibrillation (AF) after AF catheter ablation, the hard endpoints of the effect of catheter ablation on recurrent AT/AF patients after AF catheter ablation remains unclear. Our study aims to compare the effect of catheter ablation and drug therapy on recurrent AT/AF patients after AF catheter ablation.Methods and resultsFour thousand nine hundred and thirteen consecutive patients with recurrent AT/AF after catheter ablation from the China-AF registry were enrolled. The patients were divided into two study groups: the repeat catheter ablation group and the medical therapy group. The primary endpoint is a composite of cardiovascular mortality or ischaemic stroke or major bleeding events. Secondary endpoints were each component of the primary endpoints and AF recurrence rate. Landmark analysis and Cox regression were used in the statistical analysis. We chose landmark 36 months as the primary landmark date. Over a median follow-up period of 40 ± 24 months, 4913 patients were divided into either the repeat ablation group or the medical therapy group. The cumulative incidence of the composite primary outcome was significantly lower in the repeat ablation group than the medical therapy group (adjusted hazard ratio = 0.56; 95% confidence interval: 0.35-0.89; P = 0.015) of landmark 36 months (2359 patients were included in medical therapy group and 704 patients were included in repeat ablation group at landmark 36 months). However, all secondary endpoints were not statistically different in the two groups, including cardiovascular mortality, ischaemic stroke, major bleeding events, and AF recurrence rate.ConclusionBased on this research, in recurrent AT/AF patients after a catheter ablation procedure, compared with medical therapy, repeat catheter ablation may significantly reduce the risk of the endpoint of composite cardiovascular mortality, ischaemic stroke, and major bleeding events.

Project description:BackgroundDynamic functional substrate mapping of scar-related ventricular tachycardia offers better identification of ablation targets with limited ablation lesions. Several functional substrate mapping approaches have been proposed, including decrement-evoked potential (DEEP) mapping. The aim of our study was to compare the short- and long-term efficacy of a DEEP-guided versus a fixed-substrate-guided strategy for the ablation of scar-related ventricular tachycardia (VT).ResultsForty consecutive patients presenting for ablation of scar-related VT were randomized to either DEEP-guided or substrate-guided ablation. Late potentials were tagged and ablated in the non-DEEP group, while those in the DEEP group were subjected to RV extrastimulation after a drive train. Only potentials showing significant delay were ablated. Patients were followed for a median duration of 12 months. Twenty patients were allocated to the DEEP group, while the other 20 were allocated to the non-DEEP group. Twelve patients (60%) in the DEEP group had ischemic cardiomyopathy versus 10 patients (50%) in the non-DEEP group (P-value 0.525). Intraoperatively, the median percentage of points with LPs was 19% in the DEEP group and 20.6% in the non-DEEP group. The procedural time was longer in the DEEP group, approaching but missing statistical significance (P-value 0.059). VT non-inducibility was successfully accomplished in 16 patients (80%) in the DEEP group versus 17 patients (85%) in the non-DEEP group (P value 0.597). After a median follow-up duration of 12 months, the VT recurrence rate was 65% in both groups (P value 0.311), with a dropout rate of 10% in the DEEP group. As for the secondary endpoints, all-cause mortality rates were 20% and 25% in the DEEP and non-DEEP groups, respectively (P-value 0.342).ConclusionsDEEP-assisted ablation of scar-related ventricular tachycardia is a feasible strategy with comparable short- and long-term outcomes to a fixed-substrate-based strategy with more specific ablation targets, albeit relatively longer but non-significant procedural times and higher procedural deaths. The imbalance between the study groups in terms of epicardial versus endocardial mapping, although non-significant, warrants the prudent interpretation of our results. Further large-scale randomized trials are recommended.Trial registrationclinicaltrials.gov, registration number: NCT05086510, registered on 28th September 2021, record https://classic.Clinicaltrialsgov/ct2/show/NCT05086510.

Dataset Information

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

Background and aims

Methods and results

Conclusion

Trial registration

Publications

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

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