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

Seung-Jung Park

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Procedure: coronary artery bypass graft surgery

Device: everolimus-eluting stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00997828

2008-0272

Details and patient eligibility

About

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).

Full description

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.

Enrollment

888 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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