The MIRACL trial: Atorvastatin reduces recurrent ischemia post-ACS [Classics Series]

Classics Series, Landmark Trials in Medicine

1. In patients with recent acute coronary syndrome, atorvastatin 80 mg daily reduced the risk of recurrent ischemia in the following 16 week period.

2. This study did not demonstrate a significant reduction in death, cardiac arrest, or nonfatal acute myocardial infarction with statin therapy, as compared to placebo.

Original Date of Publication: April 2001

Study Rundown: Previous studies have demonstrated that reducing cholesterol levels with statins significantly reduces the risk of mortality and cardiac events in patients with years of treatment. The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial demonstrated that providing atorvastatin 80 mg daily 24-96 hours after the onset of an acute coronary syndrome (ACS) reduced the risk of recurrent ischemia as compared to placebo. In summary, treating patients with ACS with atorvastatin significantly reduces the risk of recurrent symptomatic myocardial ischemia requiring rehospitalization in the 16 weeks following an ACS (RR 0.74; 95%CI 0.57-0.95). Given that this was a large, international, multicenter trial, the findings are generalizable to patients with ACS in different settings, with different ethnicities and risk profiles. Based on these findings, statins are commonly prescribed for patients who have suffered acute coronary syndromes, in hopes of reducing the risk of recurrent ischemia.

Click to ready study in JAMA

In-Depth [randomized, controlled trial]: The MIRACL trial was originally published in JAMA in 2001. A total of 3,086 patients were enrolled from 122 centres in Europe, North America, South Africa, and Australasia. Patients were eligible if they were ≥18 years of age and had chest pain >15 minutes duration in the 24 hours prior to presentation. Exclusion criteria included serum cholesterol levels >270 mg/dL (7 mmol/L), plans for coronary revascularization at the time of screening, evidence of Q-wave MI in the past 4 weeks, and coronary artery bypass surgery in the past 3 months. Patients were randomized to receive atorvastatin 80 mg daily or placebo for 16 weeks after an ACS. The primary endpoint was a composite of death, cardiac arrest, nonfatal acute MI, or recurrent symptomatic myocardial ischemia requiring emergency rehospitalization.

At 16 weeks, patients receiving atorvastatin had a significantly lower rates of the primary endpoint compared to those taking placebo (RR 0.84; 95%CI 0.70-1.00, p=0.048), with an absolute risk reduction of 2.6% (NNT=38). Notably, there was no significant difference between the two groups in the risk of death, nonfatal acute MI, or cardiac arrest. The difference in the primary endpoint was due to a reduction in the risk of recurrent symptomatic myocardial ischemia (RR 0.74; 95%CI 0.57-0.95). The risk of abnormal liver transaminase levels was significantly higher in the atorvastatin group (2.5% vs. 0.6%, p<0.001).

Image: PD

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