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阿托伐他汀降低心脏手术患者术后房颤发生率的随机试验:ARMYDA-3(心脏手术后阿托伐他汀降低心肌心律失常)研究结果

Randomized trial of atorvastatin for reduction of postoperative atrial fibrillation in patients undergoing cardiac surgery: results of the ARMYDA-3 (Atorvastatin for Reduction of MYocardial Dysrhythmia After cardiac surgery) study.

作者信息

Patti Giuseppe, Chello Massimo, Candura Dario, Pasceri Vincenzo, D'Ambrosio Andrea, Covino Elvio, Di Sciascio Germano

机构信息

Department of Cardiovascular Sciences, Campus Bio-Medico University, Via E. Longoni, 83, 00155 Rome, Italy.

出版信息

Circulation. 2006 Oct 3;114(14):1455-61. doi: 10.1161/CIRCULATIONAHA.106.621763. Epub 2006 Sep 25.

DOI:10.1161/CIRCULATIONAHA.106.621763
PMID:17000910
Abstract

BACKGROUND

Atrial fibrillation (AF) after cardiac surgery is associated with increased risk of complications, length of stay, and cost of care. Observational evidence suggests that patients who have undergone previous statin therapy have a lower incidence of postoperative AF. We tested this observation in a randomized, controlled trial.

METHODS AND RESULTS

Two hundred patients undergoing elective cardiac surgery with cardiopulmonary bypass, without previous statin treatment or history of AF, were enrolled. Patients were randomized to atorvastatin (40 mg/d, n=101) or placebo (n=99) starting 7 days before operation. The primary end point was incidence of postoperative AF; secondary end points were length of stay, 30-day major adverse cardiac and cerebrovascular events, and postoperative C-reactive protein (CRP) variations. Atorvastatin significantly reduced the incidence of AF versus placebo (35% versus 57%, P=0.003). Accordingly, length of stay was longer in the placebo versus atorvastatin arm (6.9+/-1.4 versus 6.3+/-1.2 days, P=0.001). Peak CRP levels were lower in patients without AF (P=0.01), irrespective of randomization assignment. Multivariable analysis showed that atorvastatin treatment conferred a 61% reduction in risk of AF (odds ratio 0.39, 95% confidence interval 0.18 to 0.85, P=0.017), whereas high postoperative CRP levels were associated with increased risk (odds ratio 2.0, 95% confidence interval 1.2 to 7.0, P=0.01). The incidence of major adverse cardiac and cerebrovascular events at 30 days was similar in the 2 arms.

CONCLUSIONS

Treatment with atorvastatin 40 mg/d, initiated 7 days before surgery, significantly reduces the incidence of postoperative AF after elective cardiac surgery with cardiopulmonary bypass and shortens hospital stay. These results may influence practice patterns with regard to adjuvant pharmacological therapy before cardiac surgery.

摘要

背景

心脏手术后发生心房颤动(AF)与并发症风险增加、住院时间延长及护理费用增加相关。观察性证据表明,既往接受他汀类药物治疗的患者术后AF发生率较低。我们在一项随机对照试验中验证了这一观察结果。

方法与结果

纳入200例接受择期心脏手术并行体外循环、既往未接受他汀类药物治疗且无AF病史的患者。患者在手术前7天开始随机分组,分别接受阿托伐他汀(40mg/d,n = 101)或安慰剂(n = 99)治疗。主要终点为术后AF的发生率;次要终点为住院时间、30天主要不良心脑血管事件及术后C反应蛋白(CRP)变化。与安慰剂相比,阿托伐他汀显著降低了AF的发生率(35%对57%,P = 0.003)。相应地,安慰剂组的住院时间长于阿托伐他汀组(6.9±1.4天对6.3±1.2天,P = 0.001)。无论随机分组情况如何,未发生AF的患者CRP峰值水平较低(P = 0.01)。多变量分析显示,阿托伐他汀治疗使AF风险降低61%(比值比0.39,95%置信区间0.18至0.85,P = 0.017),而术后高CRP水平与风险增加相关(比值比2.0,95%置信区间1.2至7.0,P = 0.01)。两组30天主要不良心脑血管事件的发生率相似。

结论

术前7天开始每天服用40mg阿托伐他汀,可显著降低择期心脏手术并行体外循环术后AF的发生率,并缩短住院时间。这些结果可能会影响心脏手术前辅助药物治疗的应用模式。

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