The Multicentre Atorvastatin Plaque Stabilisation (MAPS) Study Proposed Rationale and Study Design

Background: Inflammatory mechanisms are thought to play a key role in the development of atherosclerosis
and unstable plaque. In the past, numerous studies have reported that the statins have an antiinflammatory
and anti-atherosclerotic effect unrelated to lipid-lowering. However, it is still difficult to
estimate the contribution of the specific cholesterol-independent effects of statins in counteracting the
atherosclerotic process and its sequelae.
Aim: To establish whether a short-term (3-month) treatment with atorvastatin at high versus low dose
leads to changes in carotid plaque structure and biology in terms of cellular/extracellular composition,
markers of inflammation, cell adhesion, and thrombosis. For comparison, the effect of another cholesterol-
lowering treatment will also be evaluated.
Study design: A randomised, multicentre, double-bind, parallel group study will be conducted involving
225 patients. The patients will have hypercholesterolaemia (serum total cholesterol 225–295 mg/dL) with
carotid stenosis ≥70% and be planning to undergo an endarterectomy procedure. During the 3 months
prior to the procedure, the patients will be randomly divided into three groups. Each group received
atorvastatin 10 mg/day, atorvastatin 80 mg/day, or cholestyramine 8 g/day plus sitosterol 2.5 g/day,
respectively.
Expected results: The effectiveness of atorvastatin versus control medication in inducing a favourable
plaque remodelling (stabilisation), a reduced level of inflammation (local and systemic), and the effectiveness
of a high versus low dose of atorvastatin therapy.