MAPS study.

Methods	Multicenter Atorvastatin Plaque Stabilization (MAPS) study. Multicentre randomized controlled trial.
Participants	60 hypercholesteraemic participants with symptomatic carotid stenosis undergoing CEA. Italy. Statin naive. Mean age (SD) years: A80, 79.0 (5.0); A10, 78.4 (5.1); control, 78.7 (5.3). % female: A80, 45%; A10, 65%; control, 55%.
Interventions	20 participants randomly assigned to intervention groups: 80 mg atorvastatin/ day (A80) 20 underwent surgery. 20 participants randomly assigned to 10 mg atorvastatin/day (A10); 19 underwent surgery. 20 participants randomly assigned to control group received sitosterol and cholestyramine; 19 underwent surgery. Treatment for 12 weeks before surgery. Participants continued statins for at least 1 year after surgery.
Outcomes	Blood lipid levels reported and endarterectomy specimens analysed for macrophage cell content. Clinical outcomes obtained in personal communication from authors. I MI in A10 group, I incident AF with heart failure in A80 group and 1 TIA in control group.
Funding sources	Biomedical Foundation for Cardiovascular Research and Gene Therapy of Padova and Pfizer (by an unrestricted educational grant).
Duration of statin use before surgery	12 weeks.
Notes	Additional information obtained from authors October 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomized but no further details.
Allocation concealment (selection bias)	Unclear risk	No details given.
Blinding of participants and personnel (performance bias) Mortality /complications	High risk	Described as single‐blind (user) on clinicaltrials.gov. No details of blinding in published papers. Clinicians probably not blinded.
Blinding of outcome assessment (detection bias) Mortality/complications	High risk	Described as single‐blind (user) on clinicaltrials.gov. No details of blinding in published papers. Clinical outcomes not predefined for trial.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Losses to follow‐up minimal: 1/20 in A10 group and 1/20 in control group.
Selective reporting (reporting bias)	Low risk	Authors supplied clinical outcome data on request.
Other bias	Low risk	Baseline characteristics similar in both groups.