Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
Condition: Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Diabetes Mellitus
Intervention: Coronary Artery Bypass Graft; Percutaneous Coronary Intervention
Intervention description: For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.; For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER.
The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1900.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare 5-year mortality rates in diabetic individuals with
      multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting
      (CABG) surgery or percutaneous coronary stenting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes
             Association as either:

               1. 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

               2. 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