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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: everolimus-eluting stent
* Procedure: coronary artery bypass graft surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus-eluting stent<br>everolimus-eluting stent | Device: everolimus-eluting stent<br>* Xience V stent<br>* Other names: everolimu-eluting stent;|
| Active Comparator: coronary artery bypass graft surgery<br>coronary artery bypass graft surgery | Procedure: coronary artery bypass graft surgery<br>* coronary artery bypass graft surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR) | Death includes all cause mortality. MI includes both Q wave and non Q wave, per protocol definition. TVR should be defined by the protocol. | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite of death, myocardial infarction, and any target vessel revascularization |  | at 2years | 
| Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR) |  | at 2 years | 
| MACCE (The composite of death, MI, stroke and any TVR) |  | at 2 years | 
| the composite of death, MI, and any TVR |  | at 30 days and yearly to 5 years | 
| ischemic MACE(the composite of death, MI, and any TVR) |  | at 30 days and yearly to 5 years | 
| MACCE (The composite of death, MI, stroke and ischemia-driven TVR) |  | at 30 days and yearly to 5 years | 
| ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR) |  | at 30 days and yearly to 5 years | 
| all cause death |  | at 30 days and yearly to 5 years | 
| cardiac death |  | at 30 days and yearly to 5 years | 
| myocardial infarction |  | at 3o days and yearly to 5 years | 
| stroke |  | at 30 days and yearly to 5 years | 
| ischemic-driven TVR |  | at 30 days and yearly to 5 years | 
| any target vessel revascularization |  | at 30 days and yearly to 5 years | 
| any target vessel revascularization or target lesion revascularization |  | at 30 days and yearly to 5 years | 
| non-target vessel revascularization |  | at 30 days and yearly to 5 years | 
| stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late |  | at 30 days and yearly to 5 years | 
| analysis segment and in-stent binary restenosis |  | at 9 months angiographic follow-up | 
| analysis segment and in-stent late loss |  | at 9 months angiographic follow-up | 
| angina status |  | at 2 years | 
| Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS |  | at 9 months angiographic follow-up | 
| Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS |  | at 9 months angiographic follow-up | 
| Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point) |  | at 9 months angiographic follow up | 
| Cardiac re-hospitalizations |  | at 1 years and yearly to 5 years | 
| Quality of life measurements |  | at 1 year | 
| use of cardiac medications |  | at 1 year and yearly to 5 years | 
| Dialysis/hemofiltration |  | at 30 days and yearly to 5 years | 
| Infectious complications |  | at 30 days | 
| duration of hospitalization related to the target procedure |  | at every event time | 
| 2-year MACE according to the use of FFR-guided multivessel PCI |  | at 2 years after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, stent, coronary artery bypass graft surgery, multivessel coronary artery disease