Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes - The MIRACL study: A randomized controlled trial
Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes - The MIRACL study: A randomized controlled trial
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DOI：
10.1001/jama.285.13.1711
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发表时间：
2001-04-04
影响因子：
120.7
通讯作者：
Stern, T
中科院分区：
文献类型：
--
作者：
Schwartz, GG;Olsson, AG;Stern, T
背景急性冠脉综合征后早期患者死亡率和缺血性事件复发率最高，但早期开始使用他汀类药物治疗是否可以减少这些早期事件的发生尚不清楚。目的确定急性冠脉综合征后24至96小时开始使用阿托伐他汀80 mg/d治疗是否可以降低急性冠脉综合征的发生率，减少死亡和非致命性缺血事件。设计和设置一项随机、双盲试验，从1997年5月至1999年9月进行，在欧洲、北美、南非、研究对象为3086例年龄在18岁以上的不稳定型心绞痛或非Q波急性心肌梗死患者，按中心分层，随机分为两组，分别接受阿托伐他汀（80 mg/d）治疗，或匹配的安慰剂。主要结果测量主要终点事件定义为死亡，非致命性急性心肌梗死，心脏骤停复苏，结果228例患者发生了主要终点事件，阿托伐他汀组269例患者（14.8%）和安慰剂组269例患者（17.4%）（相对风险[RR]，0.84; 95%置信区间[CI]，0.70-1.00; P = 0.048）。阿托伐他汀组和安慰剂组之间死亡、非致死性心肌梗死或心脏骤停的风险无显著差异，尽管阿托伐他汀组有客观证据表明症状性缺血的风险较低，需要紧急再住院（6.2% vs 8.4%; RR，0.74; 95% CI，0.57-0.95; P = 0.02）。同样，阿托伐他汀组和安慰剂组在冠状动脉血运重建术、心力衰竭恶化或心绞痛恶化的次要结局发生率方面没有显著差异，尽管阿托伐他汀组的卒中发生率低于安慰剂组（12 vs 24起事件; P = 0.045）。在阿托伐他汀组中，平均低密度脂蛋白胆固醇水平从124 mg/dL（3.2 mmol/L）降至72 mg/dL（1.9 mmol/L）。阿托伐他汀组肝转氨酶异常（>3倍正常值上限）较安慰剂组多见（2.5%vs0.6%，P <0.001）。结论对于急性冠脉综合征患者，阿托伐他汀80 mg/d降脂治疗可减少前16周内缺血事件的复发，主要是需要再住院的症状性缺血复发。
Context Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome, but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events.Objective To determine whether treatment with atorvastatin, 80 mg/d, initiated 24 to 96 hours after an acute coronary syndrome, reduces death and nonfatal ischemic events.Design and Setting A randomized, double-blind trial conducted from May 1997 to September 1999, with follow-up through 16 weeks at 122 clinical centers in Europe, North America, South Africa, and Australasia.Patients A total of 3086 adults aged 18 years or older with unstable angina or non-Q-wave acute myocardial infarction.Interventions Patients were stratified by center and randomly assigned to receive treatment with atorvastatin (80 mg/d) or matching placebo between 24 and 96 hours after hospital admission.Main Outcome Measures Primary end point event defined as death, nonfatal acute myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization.Results A primary end point event occurred in 228 patients (14.8%) in the atorvastatin group and 269 patients (17.4%) in the placebo group (relative risk [RR], 0.84; 95% confidence interval [CI], 0.70-1.00; P = .048). There were no significant differences in risk of death, nonfatal myocardial infarction, or cardiac arrest between the atorvastatin group and the placebo group, although the atorvastatin group had a lower risk of symptomatic ischemia with objective evidence and requiring emergency rehospitalization (6.2% vs 8.4%; RR, 0.74; 95% CI, 0.57-0.95; P = .02). Likewise, there were no significant differences between the atorvastatin group and the placebo group in the incidence of secondary outcomes of coronary revascularization procedures, worsening heart failure, or worsening angina, although there were fewer strokes in the atorvastatin group than in the placebo group (12 vs 24 events; P = .045). In the atorvastatin group, mean low-density lipoprotein cholesterol level declined from 124 mg/dL (3.2 mmol/L) to 72 mg/dL (1.9 mmol/L). Abnormal liver transaminases (>3 times upper limit of normal) were more common in the atorvastatin group than in the placebo group (2.5% vs 0.6%; P < .001).Conclusion For patients with acute coronary syndrome, lipid-lowering therapy with atorvastatin, 80 mg/d, reduces recurrent ischemic events in the first 16 weeks, mostly recurrent symptomatic ischemia requiring rehospitalization.