贝叶斯分析 Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia 试验。
Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial.
机构信息
Cardiology Department, Hospital General Universitario Gregorio Marañón, IiSGM, Universidad Complutense, CIBERCV, Dr Esquerdo 46, 28007, Madrid, Spain.
Arrhythmia Unit, Cardiology Department, Hospital Clinic and Teknon Medical Centre, c/Villarroel 170, 08036, Barcelona, Spain.
出版信息
Europace. 2023 Jul 4;25(7). doi: 10.1093/europace/euad181.
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.
背景和目的
贝叶斯分析可以为临床试验结果提供额外的见解，有助于决策过程。我们使用贝叶斯生存模型分析了基质消融与抗心律失常药物治疗有症状室性心动过速（SURVIVE-VT）试验。
方法和结果
SURVIVE-VT 试验将缺血性心肌病和单形性室性心动过速（VT）患者随机分配至导管消融或抗心律失常药物（AAD）作为一线策略。主要结局是心血管死亡、适当的植入式心脏复律除颤器电击、计划外心力衰竭住院或严重治疗相关并发症的复合结局。我们使用了具有不同大效应可能性的信息性、怀疑性和非信息性先验来计算马尔可夫链蒙特卡罗方法的后验分布。我们计算了危险比（HR）<1、<0.9 和<0.75 的概率，以及 2 年生存率估计值。在 144 名随机患者中，71 名接受了导管消融，73 名接受了 AAD。无论先验如何，导管消融有超过 98%的可能性降低主要结局（HR<1），有超过 96%的可能性降低>10%（HR<0.9）。治疗相关并发症>25%（HR<0.75）的降低概率>90%。导管消融有很高的可能性（>93%）降低无休止/缓慢未检测到的 VT/电风暴、计划外因室性心律失常住院以及总体心血管入院>25%，绝对差异分别为 15.2%、21.2%和 20.2%。
结论
在缺血性心肌病和 VT 患者中，导管消融作为一线治疗方法，与 AAD 相比，降低几种临床结局的可能性很大。我们的研究强调了贝叶斯分析在临床试验中的价值及其在指导治疗决策方面的潜力。
试验注册
ClinicalTrials.gov 标识符：NCT03734562。
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