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.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Rosenberg, Yves
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Icahn School of Medicine at Mount Sinai
Internal Medicine/Medicine
Schools of Medicine
New York
United States
Zip Code
Abdallah, Mouin S; Wang, Kaijun; Magnuson, Elizabeth A et al. (2013) Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA 310:1581-90
Magnuson, Elizabeth A; Farkouh, Michael E; Fuster, Valentin et al. (2013) Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation 127:820-31
Farkouh, Michael E; Domanski, Michael; Sleeper, Lynn A et al. (2012) Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 367:2375-84
Kovacic, Jason C; Mercader, Nadia; Torres, Miguel et al. (2012) Epithelial-to-mesenchymal and endothelial-to-mesenchymal transition: from cardiovascular development to disease. Circulation 125:1795-808
Bansilal, Sameer; Farkouh, Michael E; Hueb, Whady et al. (2012) The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry. Am Heart J 164:591-9
Solomon, Daniel H; Kremer, Joel; Curtis, Jeffrey R et al. (2010) Explaining the cardiovascular risk associated with rheumatoid arthritis: traditional risk factors versus markers of rheumatoid arthritis severity. Ann Rheum Dis 69:1920-5
Farkouh, Michael E; Dangas, George; Leon, Martin B et al. (2008) Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial. Am Heart J 155:215-23