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Early Lipid Lowering For ACS -- Miraculous or Not?

Is early initiation of statin therapy beneficial for patients with stable coronary heart disease who present with acute coronary syndrome (ACS)? International investigators conducted a manufacturer-supported, double-blind trial: They randomized 3086 patients with unstable angina or non-Q-wave MI to 16 weeks of either atorvastatin (80 mg/day) or placebo, initiated between 24 and 96 hours (mean, 63) of hospital admission (May 1997 to September 1999). Among the exclusion criteria were these: planned coronary revascularization during initial screening; recent history of Q-wave MI, coronary revascularization, or congestive heart failure (CHF); and total cholesterol level above 270 mg/dL.

Predictably, adjusted mean LDL and triglyceride levels were lower and HDL levels were higher in the treatment group than in the placebo group at 16 weeks. Abnormal liver transaminase levels were significantly more common among drug than among placebo recipients (2.5 percent vs. 0.6 percent).

Incidence of the primary combined endpoint (death, nonfatal MI, resuscitated cardiac arrest, or angina requiring rehospitalization) was significantly lower, but barely so, in the treatment group (14.8 percent vs. 17.4 percent, P=0.048; 95 percent CI, 0.70-1.00). No significant between-groups differences were noted for these individual endpoints -- death, nonfatal MI, resuscitated arrest, revascularizations, CHF requiring rehospitalization -- though the study was not powered to assess all adequately. Atorvastatin recipients did have significantly lower rates of ischemia requiring rehospitalization and stroke than did placebo recipients, but the overall number of strokes was small.

Comment: Although serious adverse events were rare in this study (suggesting that use of statins in acute therapy is safe), borderline results, as well as notable losses of patients to follow-up, compel an editorialist to urge "careful clinical interpretation" of the data. We know that early initiation of statins improves long-term adherence and achievement of target LDL levels, but to mandate in-hospital initiation of statins to reduce ischemic events in ACS patients as a result of this study's findings would be premature.

— JoAnne M. Foody, MD

Published in Journal Watch Cardiology January 1, 2002

Citation(s):

Schwartz GG et al for the MIRACL Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes -- The MIRACL study: A randomized controlled trial. JAMA 2001 Apr 4 285 1711-1718.

• Original article (Subscription may be required)
• Medline abstract (Free)

Sacks FM. Lipid-lowering therapy in acute coronary syndromes. JAMA 2001 Apr 4 285 1758-1760.

• Original article (Subscription may be required)
• Medline abstract (Free)