Abstract 11806: Early, Intensive Atorvastatin Treatment Reduces First and Recurrent Hard Cardiovascular Events After Acute Coronary Syndrome
Background: Early, intensive statin treatment is standard of care after acute coronary syndrome (ACS), but only one placebo (PBO)-controlled trial has demonstrated an early benefit of such treatment. In the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial, the primary outcome of time to first occurrence of death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina (UA) was reduced with atorvastatin (ATV) 80 mg/day, compared with PBO. However, this result was borderline significant (HR 0.84, 95% CI 0.70-1.00, p=0.048) and driven largely by reduced UA, leading some to argue that early intensive statin treatment does not modify early “hard” events after ACS. On the other hand, the efficacy of an intervention after ACS is only partially accounted for by time to first event because patients may experience multiple events of similar importance, especially when competing risk for death is relatively low.
Objective: In a post-hoc analysis of MIRACL, we evaluated the efficacy of ATV to reduce total (first and recurrent) hard cardiovascular events after ACS. Hard events were defined as death, MI, stroke, and resuscitated cardiac arrest.
Methods: 3086 patients were randomly assigned to treatment with ATV or PBO, beginning 1-4 days after ACS and continuing for 16 weeks. Time to first event was assessed by Cox regression. Total events were analyzed by Cox regression with model-based variance estimation to determine correlation between events within a subject.
Results: ATV did not significantly reduce time to first hard event (HR 0.89, 95% CI 0.72-1.11, P=0.27), but did significantly reduce total hard events (Table). To prevent 1 hard event, only 10.6 patient-years of treatment with ATV were required. The HR for total events was minimally affected by inclusion or exclusion of UA.
Conclusion: Intensive treatment with ATV reduces total hard events over 16 weeks following ACS, and is an efficient secondary prevention intervention.
Author Disclosures: G.G. Schwartz: Research Grant; Significant; F. Hoffmann-La Roche, Sanofi. Other Research Support; Modest; Cerenis, Resverlogix, The Medicines Company. R. Fayyad: Employment; Significant; Pfizer, Inc. D. DeMicco: Employment; Significant; Pfizer, Inc. M. Szarek: Consultant/Advisory Board; Modest; Arca Biopharma, Resverlogix. Consultant/Advisory Board; Significant; Regeneron, Sanofi, CSL Behring. A.G. Olsson: Other Research Support; Significant; Sanofi, Amgen, AstraZeneca, Merck, Pfizer, Roche. Consultant/Advisory Board; Significant; AstraZeneca, Merck, Pfizer, Roche.
- © 2016 by American Heart Association, Inc.