Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus

About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes Association as either: presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random of greater than 200 mg/dL (11mmol/L) or fasting plasma glucose elevation on more than one occasion of at least 126 mg/dL (7mmol/L) Currently undergoing pharmacological or non-pharmacological treatment for diabetes Angiographically confirmed multivessel CAD [critical (greater than or equal to 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] amenable to either PCI or CABG Angiographic characteristics amendable to both PCI/DES and CABG Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia Exclusion Criteria: Severe congestive heart failure (class III or IV according to New York Heart Association [NYHA] or pulmonary edema) Prior CABG surgery Prior valve surgery Prior PCI with stent implantation within 6 months of study entry Stroke within 6 months of study entry; if stroke occurred more than 6 months prior to study entry, must have significant residual neurologic involvement, as reflected in a Rankin Score of greater than 1 Prior history of significant bleeding (within 6 months of study entry) that may occur during CABG or PCI/DES related anticoagulation In-stent restenosis of a target vessel Two or more chronic total occlusions in major coronary territories Left main stenosis (at least 50% diameter stenosis) Acute ST-elevation MI (Q-wave) within 72 hours of study entry requiring revascularization Abnormal creatine kinase level (greater than twice the normal limit); or abnormal CK-MB level at study entry Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g., valve repair/replacement, aneurysmectomy, carotid endarterectomy, or carotid stent) Cannot undergo either CABG or PCI/DES because of a coexisting medical condition Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Intolerance to aspirin or both clopidogrel and ticlopidine Dementia with a score of less than 20 on the Mini Mental Status Examination (MMSE) Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g., oxygen-dependent chronic obstructive pulmonary disease, active hepatitis, significant hepatic failure, or severe kidney disease) Pregnant Currently enrolled in another clinical trial Unable to attend required follow-up visits
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Coronary Artery Bypass Graft
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Percutaneous Coronary Intervention