Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)

Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)

The purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with multivessel coronary artery disease (CAD).

The primary purpose of the BEST Study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting balloon expandable stents is not inferior to coronary artery bypass grafting for the treatment of multivessel coronary artery disease.

Inclusion Criteria:

• Age 18 years of older
• Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
• Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
• Geographically accessible and willing to come in for required study visits
• Signed informed consent.

Exclusion Criteria:

• Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
• In-stent restenosis of a target vessel
• Prior CABG surgery
• Prior PCI with stent implantation within 1 year
• Two or more chronic total occlusions in major coronary territories
• Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization
• Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization
• Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1
• Dementia with a Mini Mental Status Examination (MMSE) score of ≤ 20
• Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
• Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
• Contraindication either CABG or PCI/DES because of a coexisting clinical condition
• Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
• Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
• Suspected pregnancy. A pregnancy test (urine or serum) will be administered prerandomization to all women not clearly menopausal
• Concurrent enrollment in another clinical trial