Rationale, design, and baseline characteristics of a trial comparing aggressive lipid lowering with Atorvastatin...

This study describes the design, methodologic features, and baseline characteristics of an open-label randomized trial to determine whether aggressive lipid-lowering therapy with atorvastatin is an alternative to angioplasty or other catheter-based revascularization procedures in patients with significant coronary artery disease. Three-hundred forty-one patients with low-density lipoprotein (LDL) cholesterol > or = 115 mg/dl and > or = 1 defined narrowing of a major coronary artery were randomized to atorvastatin or the indicated catheter-based revascularization and conventional care (including lipid-lowering therapy if prescribed). Ischemic events are tracked for 18 months. The primary efficacy parameter is the incidence of an ischemic event, defined as 1 of the following: cardiovascular death, cardiac arrest, nonfatal myocardial infarction, the need for coronary bypass grafting or angioplasty, cerebrovascular accident, and worsening angina verified by objective evidence requiring hospitalization (including unstable angina).