Effect of Intensive Statin Therapy on Regression of Coronary Atherosclerosis in Patients With Acute Coronary Syndrome A Multicenter Randomized Trial Evaluated by Volumetric Intravascular Ultrasound Using Pitavastatin Versus Atorvastatin (JAPAN-ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study)
Effect of Intensive Statin Therapy on Regression of Coronary Atherosclerosis in Patients With Acute Coronary Syndrome A Multicenter Randomized Trial Evaluated by Volumetric Intravascular Ultrasound Using Pitavastatin Versus Atorvastatin (JAPAN-ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study)
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DOI：
10.1016/j.jacc.2009.04.033
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发表时间：
2009-07-21
影响因子：
24
通讯作者：
Matsuzaki, Masunori
中科院分区：
文献类型：
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作者：
Hiro, Takafumi;Kimura, Takeshi;Matsuzaki, Masunori
目的 本研究的目的是评估阿托伐他汀积极降脂治疗对急性冠脉综合征 (ACS) 患者冠状动脉斑块体积 (PV) 的退行作用是否适用于多中心环境中的其他他汀类药物。 背景 先前的一项单中心研究通过血管内超声 (IVUS) 评估报告了阿托伐他汀对 ACS 患者非罪犯部位 PV 的有益退行作用。尚未在 ACS 中评估阿托伐他汀以外的他汀类药物对 PV 的影响。方法 JAPAN-ACS（日本匹伐他汀和阿托伐他汀治疗急性冠脉综合征的评估）研究是一项前瞻性、随机、开放标签、平行组研究，在日本 33 个中心进行了盲终点评估。共有 307 名接受 IVUS 引导经皮冠状动脉介入治疗的 ACS 患者被随机分组，其中 252 名患者在基线和 8 至 12 个月的随访时接受了可评估的 IVUS 检查。患者被随机分配接受 4 毫克/天的匹伐他汀治疗或 20 毫克/天的阿托伐他汀治疗。主要终点是非罪犯冠状动脉 PV 的百分比变化。结果 匹伐他汀组和阿托伐他汀组的 PV 平均百分比变化分别为 -16.9 +/- 13.9% 和 -18.1 +/- 14.2% (p = 0.5)，这与负血管重塑相关。两组之间 PV 百分比变化平均差异的 95% 置信区间上限（1.11%，95% 置信区间：-2.27 至 4.48）未超过预先定义的非劣效性界限 5%。结论 ACS 患者服用匹伐他汀或阿托伐他汀同等地导致冠状动脉 PV 显着消退（日本急性冠脉综合征患者匹伐他汀和阿托伐他汀评估）冠状动脉综合征；NCT00242944)。 （J Am Coll Cardiol 2009；54：293-302）(C) 2009 年，美国心脏病学会基金会
ObjectivesThe objective of this study was to evaluate whether the regressive effects of aggressive lipid-lowering therapy with atorvastatin on coronary plaque volume (PV) in patients with acute coronary syndrome (ACS) are generalized for other statins in multicenter setting.BackgroundA previous single-center study reported beneficial regressive effects of atorvastatin in patients with ACS on PV of the nonculprit site by intravascular ultrasound (IVUS) evaluation. The effect of statins other than atorvastatin on PV has not been evaluated in the setting of ACS.MethodsThe JAPAN-ACS (Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome) study was a prospective, randomized, open-label, parallel group study with blind end point evaluation conducted at 33 centers in Japan. A total of 307 patients with ACS undergoing IVUS-guided percutaneous coronary intervention were randomized, and 252 patients had evaluable IVUS examinations at baseline and 8 to 12 months' follow-up. Patients were randomly assigned to receive either 4 mg/day of pitavastatin or 20 mg/day of atorvastatin. The primary end point was the percentage change in nonculprit coronary PV.ResultsThe mean percentage change in PV was -16.9 +/- 13.9% and -18.1 +/- 14.2% (p = 0.5) in the pitavastatin and atorvastatin groups, respectively, which was associated with negative vessel remodeling. The upper limit of 95% confidence interval of the mean difference in percentage change in PV between the 2 groups (1.11%, 95% confidence interval: -2.27 to 4.48) did not exceed the pre-defined noninferiority margin of 5%.ConclusionsThe administration of pitavastatin or atorvastatin in patients with ACS equivalently resulted in significant regression of coronary PV (Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome; NCT00242944). (J Am Coll Cardiol 2009; 54: 293-302) (C) 2009 by the American College of Cardiology Foundation