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阿托伐他汀10毫克与80毫克在降低既往经皮冠状动脉介入治疗患者的主要心血管事件及再次血运重建方面的疗效比较(达标新靶点研究[TNT]的事后分析)

Comparison of effectiveness of atorvastatin 10 mg versus 80 mg in reducing major cardiovascular events and repeat revascularization in patients with previous percutaneous coronary intervention (post hoc analysis of the Treating to New Targets [TNT] Study).

作者信息

Johnson Colleen, Waters David D, DeMicco David A, Breazna Andrei, Bittner Vera, Greten Heiner, Grundy Scott M, LaRosa John C

机构信息

University of California San Francisco, San Francisco, CA, USA.

出版信息

Am J Cardiol. 2008 Nov 15;102(10):1312-7. doi: 10.1016/j.amjcard.2008.07.023. Epub 2008 Sep 5.

Abstract

The Treating to New Targets (TNT) study demonstrated that intensive atorvastatin therapy to achieve low-density lipoprotein cholesterol concentrations well below recommended target levels provides an incremental clinical benefit in patients with stable coronary artery disease. This post hoc analysis of the TNT study was conducted to investigate whether this benefit extends to patients with previous percutaneous coronary intervention (PCI). A total of 10,001 patients with clinically evident coronary artery disease, including 5,407 patients with previous PCI, were randomized to atorvastatin 10 or 80 mg/day and followed for a median of 4.9 years. The primary end point was the occurrence of a first major cardiovascular event. Revascularization, a component of a secondary end point, was also examined. In patients with previous PCI, mean low-density lipoprotein cholesterol levels at study end were 79.5 mg/dl in the 80-mg arm and 100.8 mg/dl in the 10-mg arm. First major cardiovascular events occurred in 230 patients (8.6%) receiving high-dose atorvastatin and 289 patients (10.6%) receiving low-dose atorvastatin (hazard ratio 0.79, 95% confidence interval 0.67 to 0.94, p = 0.008). Repeat revascularization during follow-up (PCI or coronary artery bypass grafting) was performed in 466 patients (17.3%) in the 80-mg arm and 624 patients (22.9%) in the 10-mg arm (hazard ratio 0.73, 95% confidence interval 0.65 to 0.82, p <0.0001). In conclusion, intensive lipid lowering to a mean low-density lipoprotein cholesterol level of 79.5 mg/dl (2.1 mmol/L) with atorvastatin 80 mg/day in patients with previous PCI reduces major cardiovascular events by 21% and repeat revascularizations by 27% compared with a less intensive lipid-lowering regimen.

摘要

“治疗新目标”(TNT)研究表明,强化阿托伐他汀治疗使低密度脂蛋白胆固醇浓度远低于推荐目标水平,可为稳定型冠心病患者带来额外的临床获益。开展此项TNT研究的事后分析,旨在探究这种获益是否也适用于既往接受过经皮冠状动脉介入治疗(PCI)的患者。共有10001例有临床明显冠状动脉疾病的患者,其中包括5407例既往接受过PCI的患者,被随机分为接受每日10毫克或80毫克阿托伐他汀治疗,并随访中位时间4.9年。主要终点为首次发生的重大心血管事件。还对作为次要终点组成部分的血运重建情况进行了检查。在既往接受过PCI的患者中,研究结束时,80毫克剂量组的平均低密度脂蛋白胆固醇水平为79.5毫克/分升,10毫克剂量组为100.8毫克/分升。接受高剂量阿托伐他汀治疗的230例患者(8.6%)和接受低剂量阿托伐他汀治疗的289例患者(10.6%)发生了首次重大心血管事件(风险比0.79,95%置信区间0.67至0.94,p = 0.008)。80毫克剂量组466例患者(17.3%)和10毫克剂量组624例患者(22.9%)在随访期间进行了重复血运重建(PCI或冠状动脉旁路移植术)(风险比0.73,95%置信区间0.65至0.82,p<0.0001)。总之,与强度较低的降脂方案相比,既往接受过PCI的患者每日服用80毫克阿托伐他汀将低密度脂蛋白胆固醇水平强化降低至平均79.5毫克/分升(2.1毫摩尔/升),可使重大心血管事件减少21%,重复血运重建减少27%。

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