• L Kristin Newby, Arni Kristinsson, Manjushri V Bhapkar, Philip E Aylward, Alexios P Dimas, Werner W Klein, Darren K McGuire, David J Moliterno, Freek W A Verheugt, W Douglas Weaver, Robert M Califf, and SYMPHONY and 2nd SYMPHONY Investigators. Sibrafiban vs Aspirin to Yield Maximun Protection From Ischemic Heart Events Post-acute Coronary Syndromes.
• Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715, USA. newby001@mc.duke.edu
• JAMA. 2002 Jun 19;287(23):3087-95.

ContextThe secondary prevention benefit of therapy with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) has been clearly demonstrated; however, the role of early initiation of statins after acute coronary syndromes (ACSs) is unknown.ObjectiveTo evaluate the association of early statin initiation (< or = 7 days) after ACS with 90-day and 1-year outcomes.DesignObservational cohort from databases of 2 randomized clinical trials, SYMPHONY and 2nd SYMPHONY.SettingNine hundred thirty-one clinical centers in 37 countries.PatientsA total of 12,365 ACS patients randomized from August 1997 to August 1999 who were not taking statins prior to the index ACS and who either started statin therapy early (median, 2.0 [interquartile range, 1.0-3.1] days after ACS; n = 3952) or survived more than 5 days after ACS and never received statin therapy (n = 8413).Main Outcome MeasuresNinety-day incidence of death; death or myocardial infarction (MI); and death, MI, or severe recurrent ischemia; as well as 1-year incidence of death.ResultsNinety-day and 1-year unadjusted mortality comparison suggested early statin benefit (1.2% for early statins vs 2.1% for no statins; hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.42-0.81 for 90-day comparisons and 2.3% for early statins vs 4.4% for no statins; HR, 0.52; 95% CI, 0.40-0.68 for 1-year comparison). However, no benefit was evident for 90-day death or MI (6.5% vs 6.9%; HR, 0.95; 95% CI, 0.82-1.11) or death, MI, or severe recurrent ischemia (9.2% vs 8.9%; HR, 1.04; 95% CI, 0.92-1.18). After propensity and covariate adjustment, there were no 90-day or 1-year differences between the early-statin group and the no-statin group. The 90-day adjusted HR for death was 1.08 (95% CI, 0.75-1.56); for death or MI, 1.08 (95% CI, 0.91-1.29); and for death, MI, or severe recurrent ischemia, 1.15 (95% CI, 0.99-1.34). One-year mortality-adjusted HR was 0.99 (95% CI, 0.73-1.33). Among 2711 patients with core laboratory lipid analysis, early statin was associated with higher adjusted risk for death or death or MI at cholesterol levels below treatment guidelines but was more favorable at higher levels.ConclusionsIn this study, there was no relationship between early initiation of statin therapy and improved outcomes although our subset analysis suggests that outcomes after early statin initiation may vary with cholesterol levels. Confirmation of early treatment effects of statins on outcomes awaits the results of adequately powered randomized clinical trials.

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