Jagmeet P Singh, Mattias Wieloch, Shannon L Reynolds, Carina Blomström-Lundqvist, Alex T Sandhu, A John Camm, Shaum Kabadi, Krishna Pundi, Mintu P Turakhia, Rania Boiron, Natasha Din, Jun Fan, Caroline G Heller, Reno C Leeming, David S McKindley, Renee M Sajedian, Peter R Kowey
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Each analysis emulated the target trial using an active comparator (dronedarone vs sotalol), new user design with an as-treated approach. Primary outcomes were tested hierarchically for dronedarone vs sotalol: first for statistical significance of cardiovascular (CV) hospitalization, and then for statistical significance of ventricular arrhythmias. Propensity score matching (PSM) was used for confounding control, and negative control outcomes were used to assess residual confounding. Outcomes were evaluated by using Cox proportional hazards regression; meta-analysis was performed by using fixed effects models.</p><p><strong>Results: </strong>The dronedarone and sotalol cohorts were well balanced within databases before and after PSM (after PSM mean age range: 62.5-70.9 years; mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score range: 1.81-3.15). Negative control outcomes exhibited little-to-no evidence of residual confounding. Meta-analysis found significantly lower rates of CV hospitalization (pooled HR: 0.91; 95% CI: 0.85-0.97) and ventricular arrhythmias (pooled HR: 0.77; 95% CI: 0.69-0.85) with dronedarone vs sotalol.</p><p><strong>Conclusions: </strong>In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF.</p>","PeriodicalId":14573,"journal":{"name":"JACC. 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引用次数: 0
摘要
背景：根据心房颤动（AF）指南，Dronedarone和sotalol是抗心律失常药物（AADs）推荐用于相似人群；然而，相对安全性的数据是有限的。目的：本研究的目的是评估无人机隆与索他洛尔治疗aad初发患者AF的安全性。方法：采用一种主方案，对来自4个数据库（Optum Clinformatics Data Mart、Merative MarketScan、退伍军人健康管理局电子健康记录和瑞典国家患者登记）的4项回顾性观察队列研究进行预先指定的非干预性荟萃分析。每个分析都使用主动比较剂（drone - arone vs . sotalol）、新用户设计和治疗方法模拟目标试验。对非甾酮与索他洛尔的主要结局进行分层检验：首先检验心血管（CV）住院的统计学意义，然后检验室性心律失常的统计学意义。采用倾向评分匹配（PSM）进行混杂对照，阴性对照结果评估残留混杂。采用Cox比例风险回归评价结果；采用固定效应模型进行meta分析。结果：在PSM前后的数据库中，drone - arone和sotalol队列平衡良好(PSM后平均年龄范围：62.5-70.9岁；平均CHA2DS2-VASc评分范围：1.81-3.15)。阴性对照结果显示很少或没有残留混杂的证据。荟萃分析发现CV住院率显著降低(合并HR: 0.91；95% CI: 0.85-0.97)和室性心律失常(合并HR: 0.77；95% CI: 0.69-0.85)。结论：在这项回顾性荟萃分析中，与索他洛尔相比，无人机达龙的心血管住院率和室性心律失常率显著降低。这些发现为支持选择最合适的一线AAD用于房颤患者的心律控制提供了现实证据。
Dronedarone vs Sotalol Among Patients With Atrial Fibrillation: A Meta-Analysis of Retrospective Observational Databases.
Background: Dronedarone and sotalol are antiarrhythmic drugs (AADs) recommended in similar populations per atrial fibrillation (AF) guidelines; however, comparative safety data are limited.
Objectives: The goal of this study was to assess the safety of dronedarone vs sotalol for treatment of AF in AAD-naive patients.
Methods: This was a prespecified noninterventional meta-analysis of 4 retrospective observational cohort studies from 4 databases (Optum Clinformatics Data Mart, Merative MarketScan, Veterans Health Administration Electronic Health Record, and the Swedish National Patient Register) conducted by using one master protocol. Each analysis emulated the target trial using an active comparator (dronedarone vs sotalol), new user design with an as-treated approach. Primary outcomes were tested hierarchically for dronedarone vs sotalol: first for statistical significance of cardiovascular (CV) hospitalization, and then for statistical significance of ventricular arrhythmias. Propensity score matching (PSM) was used for confounding control, and negative control outcomes were used to assess residual confounding. Outcomes were evaluated by using Cox proportional hazards regression; meta-analysis was performed by using fixed effects models.
Results: The dronedarone and sotalol cohorts were well balanced within databases before and after PSM (after PSM mean age range: 62.5-70.9 years; mean CHA2DS2-VASc score range: 1.81-3.15). Negative control outcomes exhibited little-to-no evidence of residual confounding. Meta-analysis found significantly lower rates of CV hospitalization (pooled HR: 0.91; 95% CI: 0.85-0.97) and ventricular arrhythmias (pooled HR: 0.77; 95% CI: 0.69-0.85) with dronedarone vs sotalol.
Conclusions: In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF.
期刊介绍：
JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.
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