Rationale and design for the SARIS trial; effect of statin on atherosclerosis and vascular remodeling assessed with intravascular sonography. Effect of Statin on Atherosclerosis and vascular Remodeling assessed with Intravascular Sonography.

Purpose: The SARIS study (effect of Statin on Atherosclerosis and vascular Remodeling assessed with Intravascular Sonography) is a prospective randomized multicenter trial designed to assess both morphological and functional cardiovascular effects of atorvastatin.

Methods: Participating centers will include 50 patients with normal to mildly elevated cholesterol levels eligible for balloon angioplasty and/or stent placement of the common iliac artery. Patients will be randomized to 1-year treatment with either low-dose (10 mg) or high-dose (80 mg) atorvastatin. The morphological effects of atorvastatin will be studied using intravascular ultrasound (IVUS); the effect of atorvastatin on both plaque volume and vascular remodeling seen at 1-year follow-up will be investigated. The functional cardiovascular effects of atorvastatin will be studied using dobutamine stress echocardiography (DSE); the effect of atorvastatin on myocardial coronary flow reserve at 6-months and 1-year follow-up will be investigated. The aims of the present study are noteworthy in respect that (1) IVUS is the only available technique to sensitively measure the effect of atorvastatin on both intimal hyperplasia and vascular remodeling, and (2) DSE is a non-invasive test to objectively quantify the effect of atorvastatin on the functionality of the coronary artery.