阿托伐他汀减少心脏手术后心房颤动的随机对照研究

2006-10-08 00:00 来源:丁香园 作者:zh666 译
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——ARMYDA-3研究结果(阿托伐他汀减少心脏手术后心律失常研究)

背景:心脏手术后的房颤与增加的并发症风险、住院时间、医疗费用等有关。观察性研究表明术前使用过他汀类药物的患者术后房颤发生率较低。我们在一项随机对照研究中验证了该结论。

方法与结果:本研究入选了200例术前无房颤、未接受他汀类药物治疗、在体外循环下行选择性心脏手术的患者。患者随机分为阿托伐他汀组(101例)和安慰剂组(99例),所有患者均在术前7天开始服用阿托伐他汀或安慰剂。研究的主要终点是术后发生房颤,次要终点是住院时间、30天内发生主要心脑血管不良事件、术后C反应蛋白变化。与安慰剂相比,阿托伐他汀显著降低房颤发生率(35%:57%,P=0.003)。同时,安慰剂组的住院时间比他汀组长(6.9±1.4天:6.3±1.2 天,P=0.001)。未发生房颤患者的C反应蛋白峰值较低,与服药的随机分组无关。多变量分析显示,阿托伐他汀治疗可减少房颤发生率61%(比值比:0.39,95%可信区间:0.18-0.85,P=0.017),而术后高水平的C反应蛋白与房颤发生率有关(比值比:2.0,95%可信区间:1.2-7.0, P=0.01)。两组患者30天内主要心脑血管不良事件的发生率相似。

结论:在心脏手术前7天开始服用阿托伐他汀40mg/日,显著减少体外循环下选择性心脏手术后房颤发生率,可以缩短住院时间。该结果可能会影响心脏手术前辅助药物治疗方案。


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

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

From the Department of Cardiovascular Sciences (G.P., M.C., D.C., A.D., E.C., G.D.S.), Campus Bio-Medico University, Rome, Italy, and Interventional Cardiology (V.P.), S. Filippo Neri Hospital, Rome, Italy.

Correspondence to Professor Germano Di Sciascio, MD, Department of Cardiovascular Sciences, Campus Bio-Medico University, Via E. Longoni, 83, 00155 Rome, Italy. E-mail g.disciascio@unicampus.it

Received February 17, 2006; revision received July 23, 2006; accepted August 7, 2006.

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.

 

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