Methods:

The FACTOR-64 study was a randomized clinical trial in which 900 patients with ≥ 3- to 5-year history of type 1 or 2 diabetes and without symptoms of CAD were recruited from 45 clinics and practices of a single health system (Intermountain Healthcare, Utah), enrolled at a single-site coordinating center, and randomly assigned to CAD screening with CCTA (n = 452) or to standard national guidelines-based optimal diabetes care (n = 448) (targets: glycated hemoglobin level <7.0%, low-density lipoprotein cholesterol level <100 mg/dl, systolic blood pressure <130 mm Hg). Based on CCTA findings, standard therapy was recommended versus aggressive therapy (targets: glycated hemoglobin level <6.0%, low-density lipoprotein cholesterol level <70 mg/dl, high-density lipoprotein cholesterol level >50 mg/dl [women] or >40 mg/dl [men], triglycerides level <150 mg/dl, systolic blood pressure <120 mm Hg) versus aggressive therapy with invasive coronary angiography. Enrollment occurred between July 2007 and May 2013, and follow-up extended to August 2014. The primary outcome was a composite of all-cause mortality, nonfatal myocardial infarction (MI), or unstable angina requiring hospitalization; the secondary outcome was ischemic major adverse cardiovascular events (MACE) (composite of CAD death, nonfatal MI, or unstable angina).