Rationale and design for the SARIS trial; 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 randomi zed multicenter trial designed to assess both morphological and functional cardiovascular effects of atorvastatin. Methods. Participating centers will include 50 patients with normal to mild ly elevated cholesterol levels eligible for balloon angioplasty and/or sten t placement of the common iliac artery. Patients will be randomized to 1-ye ar treatment with either low-dose (10 mg) or high-dose (80 mg) atorvastatin . The morphological effects of atorvastatin will be studied using intravasc ular ultrasound (IVUS); the effect of atorvastatin on both plaque volume an d vascular remodeling seen at 1-year follow-up will be investigated. The fu nctional cardiovascular effects of atorvastatin will be studied using dobut amine stress echocardiography (DSE); the effect of atorvastatin on myocardi al coronary flow reserve at 6-months and 1-year follow-up will be investiga ted. The aims of the present study are noteworthy in respect that (1) IVUS is the only available technique to sensitively measure the effect of atorva statin on both intimal hyperplasia and vascular remodeling, and (2) DSE is a non-invasive test to objectively quantify the effect of atorvastatin on t he functionality of the coronary artery.