永久性心房颤动患者使用地高辛：来自RACE II研究的数据。
Digoxin in patients with permanent atrial fibrillation: data from the RACE II study.
作者信息
Mulder Bart A, Van Veldhuisen Dirk J, Crijns Harry J G M, Tijssen Jan G P, Hillege Hans L, Alings Marco, Rienstra Michiel, Van den Berg Maarten P, Van Gelder Isabelle C
机构信息
Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.
出版信息
Heart Rhythm. 2014 Sep;11(9):1543-50. doi: 10.1016/j.hrthm.2014.06.007. Epub 2014 Jun 9.
BACKGROUND
The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation.
OBJECTIVES
To assess the association of digoxin with cardiovascular (CV) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF: A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets.
METHODS
The primary outcome was a composite of CV morbidity and mortality. Secondary outcomes included CV hospitalization and all-cause mortality or heart failure (HF) hospitalization. Of the 614 patients, 608 (99%) completed the dose-adjustment phase. Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up. The median follow-up period was 2.9 years (interquartile range 2.7-3.0 years).
RESULTS
In total, 284 patients (46.7%) used digoxin after the dose-adjustment phase (median dosage 0.250 mg; interquartile range 0.0625-0.750 mg). These patients were more often women, previously admitted for HF, had an increased left ventricular end-systolic diameter, and more often randomized to strict rate control. By using Cox proportional hazards regression analysis, the use of digoxin was not associated with an increased risk for the primary and secondary outcomes. For the primary outcome, the 3-year estimated cumulative incidence was 12.9% vs 13.4% in the digoxin group vs the no-digoxin group (unadjusted hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.62-1.52). Incidence was 19.4% vs. 19.5% for CV hospitalization (unadjusted HR 1.00; 95% CI 0.69-1.45) and 6.6% vs. 9.9% for all-cause mortality or HF hospitalization (unadjusted HR 0.62; 95% CI 0.34-1.13) in the digoxin group vs the no-digoxin group.
CONCLUSION
The use of digoxin was not associated with increased morbidity and mortality.
背景
心房颤动节律管理随访研究试验表明，地高辛与心房颤动患者死亡率增加相关。
目的
评估在荷兰永久性房颤心率控制疗效：宽松与严格心率控制比较II试验中，地高辛与永久性心房颤动患者心血管（CV）发病率和死亡率的关联，并评估地高辛在实现心率目标中的作用。
方法
主要结局是CV发病率和死亡率的复合指标。次要结局包括CV住院以及全因死亡率或心力衰竭（HF）住院。614例患者中，608例（99%）完成了剂量调整阶段。从剂量调整阶段结束至随访结束分析结局事件。中位随访期为2.9年（四分位间距2.7 - 3.0年）。
结果
总共284例患者（46.7%）在剂量调整阶段后使用地高辛（中位剂量0.250 mg；四分位间距0.0625 - 0.750 mg）。这些患者女性更多，既往因HF住院，左心室收缩末期直径增加，且更常被随机分配至严格心率控制组。通过Cox比例风险回归分析，地高辛的使用与主要和次要结局风险增加无关。对于主要结局，地高辛组与非地高辛组的3年估计累积发病率分别为12.9%和13.4%（未调整风险比[HR] 0.97；95%置信区间[CI] 0.62 - 1.52）。地高辛组与非地高辛组的CV住院发病率分别为19.4%和19.5%（未调整HR 1.00；95% CI 0.69 - 1.45），全因死亡率或HF住院发病率分别为6.6%和9.9%（未调整HR 0.62；95% CI 0.34 - 1.13）。
结论
地高辛的使用与发病率和死亡率增加无关。
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