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

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
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DOI:
10.1161/circulationaha.106.621763
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发表时间:
2006-10-03
期刊:
影响因子:
37.8
通讯作者:
Di Sciascio, Germano
Di Sciascio, Germano
中科院分区:
医学1区
文献类型:
--
作者:
Patti, Giuseppe;Chello, Massimo;Di Sciascio, Germano

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背景:心脏手术后心房颤动(AF)与并发症风险增加、住院时间延长和护理费用增加有关。观察性证据表明,既往接受过他汀类药物治疗的患者术后房颤发生率较低。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:入选200例择期心脏手术合并体外循环患者,既往无他汀类药物治疗或房颤史。从手术前7天开始,患者随机接受阿托伐他汀(40 mg/d, n=101)或安慰剂(n=99)治疗。主要终点为术后房颤发生率;次要终点为住院时间、30天主要心脑血管不良事件和术后c反应蛋白(CRP)变化。与安慰剂相比,阿托伐他汀显著降低房颤发生率(35%对57%,P=0.003)。因此,安慰剂组比阿托伐他汀组的住院时间更长(6.9 +/- 1.4天和6.3 +/- 1.2天,P=0.001)。无房颤的患者CRP峰值水平较低(P=0.01),与随机分配无关。多变量分析显示,阿托伐他汀治疗可使房颤风险降低61%(优势比0.39,95%可信区间0.18 ~ 0.85,P=0.017),而术后高CRP水平与房颤风险增加相关(优势比2.0,95%可信区间1.2 ~ 7.0,P=0.01)。两组患者30天主要心脑血管不良事件发生率相似。结论:术前7天开始使用阿托伐他汀40mg /d,可显著降低择期心脏手术合并体外循环术后房颤的发生率,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实践模式。
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.