Authors
Schwartz GG, Olsson AG, Ezekowitz MD, et al.
Title
Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial
References
JAMA. 2001;285(13):1711-1718
Background
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.
Purpose
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
Multicenter, randomized, double blinded placebo controlled trial 3086 patients >18 years with unstable angina or non-Q wave acute myocardial infarction Receive study treatment within 24-96 hours after hospital admission
Exclusion Criteria
Total cholesterol >7.0 mmol/L Planned coronary revascularization Evidence of Q wave MI in the preceding 4 weeks CABG in the preceding 3 months; PCI in the preceding 6 months LBBB Congestive heart failure Concurrent lipid therapy
Follow-Up
16 weeks
Treatment Regimen
Atorvastatin 80 mg/day or placebo for 16 weeks Follow-up visits 2, 6, and 16 weeks after initiation. Lipid and routine blood work at 6 and 16 weeks.
Results
Primary Endpoints The primary combined end point was death, nonfatal acute MI, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia with objective evidence requiring emergency rehospitalization. 14.8% (atorvastatin) vs. 17.4% (placebo); p=0.048 Secondary Outcomes Secondary end points were the occurrence of each primary end point component as well as nonfatal stroke, new or worsening congestive heart failure requiring hospitalization, worsening angina requiring rehospitalization but without new objective evidence of ischemia, coronary revascularization by surgical or percutaneous means, time to first occurrence of any primary or secondary end point, and percentage changes in blood lipid levels from baseline to end of study. No significant reduction in any secondary endpoint except for reduction in symptomatic ischemia requiring emergent rehospitalization. 6.2% (atorvastatin) vs. 8.4% (placebo); p=0.02
Summary
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.