Department of Cardiology, Gentofte Hospital, University of Copenhagen, 2009 Hellerup, Denmark.
Europace. 2011 Aug;13(8):1118-26. doi: 10.1093/europace/eur102. Epub 2011 May 15.
Cardiovascular (CV) hospitalization is a predictor of CV mortality and has a negative impact on patients' quality of life. The primary endpoint of A placebo-controlled, double-blind, parallel-arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENTs with Atrial fibrillation/atrial flutter (ATHENA), a composite of first CV hospitalization or death from any cause, was significantly reduced by dronedarone. This post hoc analysis evaluated the secondary endpoint of CV hospitalization and the clinical benefit of dronedarone on the number and duration of CV hospitalizations in patients with atrial fibrillation (AF).
ATHENA was a double-blind, parallel group study in 4628 patients with a history of paroxysmal/persistent AF and additional risk factors, treated with placebo or dronedarone. Dronedarone treatment significantly reduced the risk of first CV hospitalization (P < 0.0001 vs. placebo), while the risk of first non-CV hospitalization was similar in both groups (P = 0.77). About half of the CV hospitalizations were AF-related, with a median duration of hospital stay of four nights. The risk of any hospitalization for AF [hazard ratio (95% confidence interval) 0.626 (0.546-0.719)] and duration of hospital stay were significantly reduced by dronedarone (P < 0.0001 vs. placebo). Dronedarone treatment reduced total hospitalizations for acute coronary syndrome (P = 0.0105) and the time between the first AF/atrial flutter recurrence and CV hospitalization/death (P = 0.0048). Hospitalization burden was significantly reduced across all levels of care (P < 0.05). Cumulative incidence data indicated that the effects of dronedarone persisted for at least 24 months.
Dronedarone reduced the risk for CV hospitalization and the total hospitalization burden in this patient group. The trial is registered under ClinicalTrials.gov #NCT 00174785.
心血管（CV）住院是 CV 死亡率的预测指标，对患者的生活质量有负面影响。A 期临床试验的主要终点是评估双盲、平行臂、安慰剂对照试验中使用普罗帕酮 400mg bid 预防心房颤动/心房扑动（ATHENA）患者心血管住院或任何原因死亡的疗效，ATHENA 是由首次 CV 住院或任何原因死亡组成的复合终点，普罗帕酮显著降低。这项事后分析评估了普罗帕酮对心房颤动（AF）患者 CV 住院次数和持续时间的临床益处的次要终点。
ATHENA 是一项在 4628 例有阵发性/持续性 AF 和其他危险因素的患者中进行的双盲、平行组研究，接受安慰剂或普罗帕酮治疗。普罗帕酮治疗显著降低了首次 CV 住院的风险（P<0.0001 与安慰剂相比），而两组首次非 CV 住院的风险相似（P=0.77）。约一半的 CV 住院与 AF 相关，住院时间中位数为四个晚上。普罗帕酮显著降低了任何 AF 住院的风险[风险比（95%置信区间）0.626（0.546-0.719）]和住院时间（P<0.0001 与安慰剂相比）。普罗帕酮治疗降低了急性冠状动脉综合征的总住院率（P=0.0105）和首次 AF/心房扑动复发与 CV 住院/死亡之间的时间（P=0.0048）。所有级别的护理住院负担均显著降低（P<0.05）。累积发病率数据表明，普罗帕酮的作用至少持续了 24 个月。
普罗帕酮降低了该患者群体的 CV 住院风险和总住院负担。该试验在 ClinicalTrials.gov 注册，编号为#NCT 00174785。
