Division of Cardiovascular Medicine, Lankenau Heart Institute, Wynnewood, Pennsylvania.
Department of Cardiology, Maastricht University Medical Center and CARIM, Maastricht, Netherlands.
J Cardiovasc Electrophysiol. 2020 May;31(5):1022-1030. doi: 10.1111/jce.14405. Epub 2020 Mar 5.
The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization.
Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.
Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P < .01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups.
Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.
EURIDIS 和 ADONIS 三期研究评估了决奈达隆在非永久性房颤（AF）/心房扑动（AFL）患者中的复发性房颤（AF）/心房扑动（AFL）复发的疗效。在此，我们评估了这些研究中基于随机前是否需要电复律，患者特征和/或治疗结果是否存在差异。
根据电复律状态评估了首次经裁决的 AF/AFL 复发、有症状复发、心血管住院/死亡和 AF 住院的时间，以及安全性。
在随机分组的 1237 例患者中（2:1 决奈达隆：安慰剂），364 例需要基线电复律（决奈达隆 243 例，安慰剂 121 例）。与未接受电复律的患者相比，需要电复律的患者有更高的心血管合并症发生率和更短的首次 AF/AFL 复发时间。无论电复律状态如何，决奈达隆与首次 AF/AFL 复发的中位时间延长相关（电复律：50 天 vs 15 天，风险比 [HR] 0.76；95%置信区间 [CI]，0.59-0.97；P=0.02；非电复律：150 天 vs 77 天，HR 0.76；95% CI，0.64-0.90；P<0.01）。无论电复律状态如何，与安慰剂相比，决奈达隆与更长的中位有症状复发时间相关（电复律：347 天 vs 87 天，HR 0.65；95% CI，0.49-0.87；非电复律：288 天 vs 120 天，HR 0.74；95% CI，0.62-0.90）。无论电复律状态如何，与安慰剂相比，使用决奈达隆可降低心血管住院/死亡和首次 AF 住院的风险，但差异无统计学意义。两组的决奈达隆安全性相似。
需要基线电复律的患者代表了一个独特的人群，他们有更多的潜在心血管疾病，并且 AF/AFL 复发的时间更短。无论电复律状态如何，决奈达隆与安慰剂相比，均能改善疗效。
