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新型预防或限制事件(那不勒斯) II 试验方法:阿托伐他汀单次高负荷剂量对围手术期心肌梗死的影响。

Novel approaches for preventing or limiting events (Naples) II trial: impact of a single high loading dose of atorvastatin on periprocedural myocardial infarction.

机构信息

Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Via Orazio, 2, I-80121 Naples, Italy.

出版信息

J Am Coll Cardiol. 2009 Dec 1;54(23):2157-63. doi: 10.1016/j.jacc.2009.07.005. Epub 2009 Aug 6.

DOI:10.1016/j.jacc.2009.07.005
PMID:19664895
Abstract

OBJECTIVES

Atorvastatin administered at least 7 days before the percutaneous coronary intervention (PCI) reduces the rate of periprocedural myocardial infarction (MI). It is unknown whether a single, high (80 mg) loading dose of atorvastatin may reduce the rate of periprocedural MI.

BACKGROUND

Periprocedural MI is a prognostically important complication of PCI.

METHODS

The day before the elective PCI, 668 statin-naive patients were randomly assigned to atorvastatin 80 mg (atorvastatin group; n = 338) or no statin treatment (control group; n = 330). Creatine kinase-myocardial isoenzyme (CK-MB) (upper limit of normal [ULN] 3.5 ng/ml) and cardiac troponin I (ULN 0.10 ng/ml) were assessed before and 6 and 12 h after the intervention. Periprocedural MI was defined as a CK-MB elevation >3x ULN alone or associated with chest pain or ST-segment or T-wave abnormalities.

RESULTS

The incidence of a periprocedural MI was 9.5% in the atorvastatin group and 15.8% in the control group (odds ratio: 0.56; 95% confidence interval: 0.35 to 0.89; p = 0.014). Median CK-MB peak after PCI was 2.10 ng/ml (interquartile range 1.00 to 12.50 ng/ml) in the atorvastatin group and 3.20 ng/ml (interquartile range 1.37 to 16.07 ng/ml) in the control group (p = 0.014). The incidence of cardiac troponin I elevation >3x ULN was 26.6% in the atorvastatin group and 39.1% in the control group (odds ratio: 0.56; 95% confidence interval: 0.40 to 0.78; p < 0.001).

CONCLUSIONS

A single, high (80 mg) loading (within 24 h) dose of atorvastatin reduces the incidence of periprocedural MI in elective PCI.

摘要

目的

阿托伐他汀在经皮冠状动脉介入治疗(PCI)前至少 7 天给药可降低围手术期心肌梗死(MI)的发生率。单次高剂量(80mg)阿托伐他汀是否可降低围手术期 MI 的发生率尚不清楚。

背景

围手术期 MI 是 PCI 的一种预后重要的并发症。

方法

在择期 PCI 前一天,668 名他汀类药物初治患者被随机分配至阿托伐他汀 80mg 组(阿托伐他汀组,n=338)或未接受他汀类药物治疗组(对照组,n=330)。在干预前及干预后 6 小时和 12 小时评估肌酸激酶同工酶-MB(正常上限[ULN]3.5ng/ml)和心脏肌钙蛋白 I(ULN 0.10ng/ml)。围手术期 MI 定义为 CK-MB 升高>3xULN 时,或伴有胸痛或 ST 段或 T 波异常。

结果

阿托伐他汀组围手术期 MI 的发生率为 9.5%,对照组为 15.8%(比值比:0.56;95%置信区间:0.35 至 0.89;p=0.014)。PCI 后 CK-MB 峰值中位数在阿托伐他汀组为 2.10ng/ml(四分位距 1.00 至 12.50ng/ml),在对照组为 3.20ng/ml(四分位距 1.37 至 16.07ng/ml)(p=0.014)。阿托伐他汀组肌钙蛋白 I 升高>3xULN 的发生率为 26.6%,对照组为 39.1%(比值比:0.56;95%置信区间:0.40 至 0.78;p<0.001)。

结论

单次高剂量(80mg)负荷(24 小时内)剂量的阿托伐他汀可降低择期 PCI 围手术期 MI 的发生率。

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