Coronary Revascularization in Diabetic Patients

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DESCRIPTION (provided by applicant): FREEDOM is a multicenter, prospective, randomized clinical trial comparing coronary artery bypass surgery (CABG) with percutaneous coronary stenting using the Sirolimus-eluting stent in diabetic patients with multivessel disease. The main objective of the study is to compare a multivessel stenting strategy using Sirolimus-eluting stents with CABG with respect to mortality in 5 years of follow-up. The study population will consist of 2300 patients (1150/arm) with diabetes mellitus diagnosed according to the American Diabetes Association, and multivessel coronary artery disease (CAD) (2 or more stenotic lesions in at least 2 major epicardial coronary arteries), amenable to either PCI with stenting or surgical revascularization. All subjects will be screened to ensure that all inclusion and exclusion criteria are fulfilled prior to study entry. A written informed consent will be obtained prior to enrollment in the study. Patients who meet the eligibility criteria will be randomized on a 1:1 basis either to CABG or multivessel stenting using Sirolimus-eluting stents. The primary outcome of the study is the difference in mortality rates between the stent group and the CABG group over the 5-year period. The following secondary endpoints will be assessed: 1) survival functions over years 1, 2, 3 and 4; 2) individual components of MACCE in-hospital at 30 days, 6 months and 12 months; 3) quality of life pre- and post-randomization every 6 months up to 5 years; 4) neuro-cognitive function pre-procedure and 6 months, 1 year and 5 years post-procedure; and 5) cost-effectiveness analyses, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events. We plan to recruit all patients over the course of 18 months at 100 clinical sites.