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阿托伐他汀预防肺静脉隔离术后心房颤动复发:一项双盲、安慰剂对照、随机临床试验。

Atorvastatin for prevention of atrial fibrillation recurrence following pulmonary vein isolation: a double-blind, placebo-controlled, randomized trial.

机构信息

Rambam Medical Center, Haifa, Israel.

出版信息

Heart Rhythm. 2012 Feb;9(2):172-8. doi: 10.1016/j.hrthm.2011.09.016. Epub 2011 Sep 13.

Abstract

BACKGROUND

It is known that statins are effective in preventing atrial fibrillation (AF) in patients undergoing cardiac surgery.

OBJECTIVE

The purpose of this study was to evaluate the efficacy of statins in preventing AF recurrence following left atrial ablation.

METHODS

One hundred twenty-five patients who had no statin indication undergoing catheter ablation due to drug-refractory paroxysmal (n = 90) or persistent (n = 35) AF were randomized in a prospective, double-blind, placebo-controlled trial to receive 80 mg atorvastatin (n = 62) or placebo (n = 63) for 3 months. The primary endpoint was freedom from symptomatic AF at 3 months. Secondary endpoints included freedom from any atrial arrhythmia recurrence irrespective of symptoms, quality of life (QoL), and reduction in C-reactive protein (CRP).

RESULTS

At 3 months, 95% of patients in the atorvastatin group were free of symptomatic AF compared with 93.5% in the placebo group (P = .75). Similarly, 85% of patients treated in the atorvastatin group remained free of any recurrent atrial arrhythmia vs 88% of patients in the placebo group (P = .37). Mean CRP levels decreased in the atorvastatin group (mean change -0.75 ± 3, P = .02) and increased in the placebo group (mean change 2.1 ± 19.9, P = .48). Mean QoL score improved significantly in both groups (mean change 13.14 ± 18.2 in the atorvastatin group and 11.10 ± 17.7 in the placebo group, P = .53).

CONCLUSION

In patients with no standard indication for statin therapy, treatment with atorvastatin 80 mg/day following AF ablation does not decrease the risk of AF recurrence in the first 3 months and should not be routinely administered to prevent periprocedural arrhythmias.

摘要

背景

已知他汀类药物可有效预防心脏手术患者的心房颤动(AF)。

目的

本研究旨在评估他汀类药物预防左心房消融后 AF 复发的疗效。

方法

125 例因药物难治性阵发性(n = 90)或持续性(n = 35)AF 而接受导管消融且无他汀类药物适应证的患者,以前瞻性、双盲、安慰剂对照的方式随机分为阿托伐他汀 80 mg 组(n = 62)或安慰剂组(n = 63),治疗 3 个月。主要终点为 3 个月时无症状 AF 无复发。次要终点包括无论症状如何,无任何房性心律失常复发、生活质量(QoL)以及 C 反应蛋白(CRP)降低。

结果

阿托伐他汀组 95%的患者在 3 个月时无症状 AF 复发,安慰剂组为 93.5%(P =.75)。同样,阿托伐他汀组 85%的患者无任何复发性房性心律失常,安慰剂组为 88%(P =.37)。阿托伐他汀组 CRP 水平降低(平均变化-0.75 ± 3,P =.02),安慰剂组升高(平均变化 2.1 ± 19.9,P =.48)。两组的 QoL 评分均显著改善(阿托伐他汀组平均变化 13.14 ± 18.2,安慰剂组为 11.10 ± 17.7,P =.53)。

结论

在没有他汀类药物治疗标准适应证的患者中,AF 消融后每天服用 80mg 阿托伐他汀并不能降低前 3 个月 AF 复发的风险,不应该常规用于预防围术期心律失常。

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