BACKGROUND Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system. METHODS Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes. RESULTS The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA2DS2-VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant. CONCLUSIONS Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials.

中文翻译：

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决奈达隆与索他洛尔在未使用过抗心律失常药物的患有心房颤动的退伍军人中的比较。

背景技术索他洛尔和决奈达隆均用于维持房颤患者的窦性心律。然而，索他洛尔需要对 QT 间期延长和致心律失常进行初步监测，而决奈达隆则不需要。这些治疗方法可用于可比较的患者，但其安全性和有效性尚未进行直接比较。因此，我们使用大型医疗保健系统的数据回顾性评估了有效性和安全性。方法 根据退伍军人健康管理局的数据，我们确定了 11 296 名在 2012 年或之后接受过决奈达隆或索他洛尔治疗的房颤患者，其中 11 296 名未接受过抗心律失常药物治疗。我们排除了既往患有传导疾病、起搏器或植入式心律转复除颤器、室性心律失常、癌症、肾衰竭、肝病或心力衰竭的患者。我们使用自然语言处理来识别和比较治疗组之间的基线左心室射血分数。我们根据患者人口统计、合并症和药物使用 1:1 倾向评分匹配以及 Cox 回归来比较策略。为了评估残余混杂因素，我们进行了具有不合理结果的证伪分析。结果 匹配队列由 6212 名患者组成（3106 名决奈达隆和 3106 名索他洛尔；平均 [±SD] 年龄，71±10 岁；2.5% 女性；平均 [±SD] CHA2DS2-VASC，2±1.3）。决奈达隆和索他洛尔使用者的平均（±SD）左心室射血分数分别为 55±11 和 58±10。与索他洛尔相比，决奈达隆与心血管住院风险（风险比，1.03 [95% CI，0.88-1.21]）或全因死亡率（风险比，0.89 [95% CI，0.68-1.16]）没有显着相关性。 ]）。然而，决奈达隆与室性致心律失常事件（风险比，0.53 [95% CI，0.38-0.74]）和症状性心动过缓（风险比，0.56 [95% CI，0.37-0.87]）的风险显着降低相关。主要发现在敏感性分析中保持稳定。证伪分析并不显着。结论 与索他洛尔相比，决奈达隆与较低的室性心律失常事件和传导障碍风险相关，而心血管住院事件和死亡风险没有差异。这些观察数据为前瞻性疗效和安全性试验提供了基础。