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Effects of Early Treatment With Statins on Short-term Clinical Outcomes in Acute Coronary Syndromes
A Meta-analysis of Randomized Controlled Trials
Matthias Briel, MD;
Gregory G. Schwartz, MD, PhD;
Peter L. Thompson, MD, FRACP;
James A. de Lemos, MD;
Michael A. Blazing, MD;
Gerrit-Anne van Es, PhD;
Meral Kayikçio lu, MD;
Hans-Richard Arntz, MD;
Frank R. den Hartog, MD;
Nic J. G. M. Veeger, MSc;
Furio Colivicchi, MD;
Jocelyn Dupuis, MD, PhD;
Shinya Okazaki, MD;
R. Scott Wright, MD;
Heiner C. Bucher, MD, MPH;
Alain J. Nordmann, MD, MSc
JAMA. 2006;295:2046-2056.
Context The short-term effects of early treatment with statins in patients after the onset of acute coronary syndromes (ACS) for the outcomes of death, myocardial infarction (MI), and stroke are unclear.
Objective To evaluate relevant outcomes of patients from randomized controlled trials comparing early statin therapy with placebo or usual care at 1 and 4 months following ACS.
Data Sources and Study Selection Systematic search of electronic databases (MEDLINE, EMBASE, PASCAL, Cochrane Central Register) from their inception to August 2005, which was supplemented by contact with experts in the field. Two reviewers independently determined the eligibility of randomized controlled trials that compared treatment with statins with a control, were initiated within 14 days after onset of ACS, and had a minimal follow-up of 30 days. Trials with cerivastatin were only included in a sensitivity analysis.
Data Extraction Information on baseline characteristics of included trials and patients, reported methodological quality, lipid levels, and clinical outcome was independently extracted by 2 investigators. Investigators from each included trial contributed additional data if necessary.
Data Synthesis Twelve trials involving 13 024 patients with ACS were included in the meta-analysis. The risk ratios for the combined end point of death, MI, and stroke for patients treated with early statin therapy compared with control therapy were 0.93 (95% confidence interval [CI], 0.80-1.09; P = .39) at 1 month and 0.93 (95% CI, 0.81-1.07; P = .30) at 4 months following ACS. There were no statistically significant risk reductions from statins for total death, total MI, total stroke, cardiovascular death, fatal or nonfatal MI, or revascularization procedures (percutaneous coronary intervention or coronary artery bypass graft surgery). Sensitivity analyses with restriction to trials of high quality or with additional data from a large trial using cerivastatin indicated summary risk ratios even closer to 1.
Conclusion Based on available evidence, initiation of statin therapy within 14 days following onset of ACS does not reduce death, MI, or stroke up to 4 months.
Author Affiliations: Basel Institute for Clinical Epidemiology, University Hospital Basel, Basel, Switzerland (Drs Briel, Bucher, and Nordmann); VA Medical Center and University of Colorado Health Sciences Center, Denver (Dr Schwartz); Sir Charles Gairdner Hospital, University of Western Australia, Perth (Dr Thompson); University of Texas Southwestern Medical School, Dallas (Dr de Lemos); Duke Clinical Research Institute, Durham, NC (Dr Blazing); Cardialysis BV, Rotterdam, the Netherlands (Dr van Es); Ege University School of Medicine, Izmir, Turkey (Dr Kayikçiolu); Charité Campus Benjamin Franklin, Berlin, Germany (Dr Arntz); Gelderse Vallei Hospital, Ede, the Netherlands (Dr den Hartog); University Medical Center Groningen, Groningen, the Netherlands (Mr Veeger); S. Filippo Neri Hospital, Rome, Italy (Dr Colivicchi); Montreal Heart Institute, Montreal, Quebec (Dr Dupuis); Juntendo University School of Medicine, Tokyo, Japan (Dr Okazaki); and the Mayo Clinic, Rochester, Minn (Dr Wright).
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