Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease

Study Overview
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Brief Summary
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The primary objective of the BEST extended 10Y follow-up study is to compare the safety and effectiveness of coronary stent implantation using everolimus-eluting balloon-expandable stents with bypass grafting for the treatment of multivessel coronary artery disease at minimum of 10 years follow-up.

Official Title
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Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease: The BEST Extended 10 Y Follow-up

Conditions
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Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: coronary stent implantation
* Procedure: bypass grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Angiographically confirmed multivessel coronary artery disease [critical (>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter) at least two separate coronary artery territories (the right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD)] and are expected to be equally treatable with PCI(Percutaneous Coronary Intervention) or CABG(coronary artery bypass graft) by interventionalists and surgeons at the investigating site. 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: The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and TIclopidine Sirolimus, paclitaxel, ABT 578 Stainless steel and/or Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled). Severe congestive heart failure (class III or IV according to New York Heart Association (NYHA) Functional Classification, or pulmonary edema) at the time of enrollment. The degree of left ventricular ejection fraction is not considered as an index of exclusion. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent). Prior CABG surgery Prior PCI with DES implantation within 1 year Two or more chronic total occlusions in major coronary territories Acute ST-elevation myocardial infarction(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. When the cardiac enzyme is returned to normal, those can be enrolled. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement. 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(drug eluting stent) related anticoagulation. Contraindication either CABG or PCI/DES because of a coexisting clinical condition Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine Suspected pregnancy. Concurrent enrollment in another clinical trial Left main stenosis (at least 50% diameter stenosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| multivessel coronary artery disease<br>From BEST trial study population_NCT00997828 | Procedure: coronary stent implantation<br>* coronary stent implantation using everolimus-eluting balloon expandable stents<br>Procedure: bypass grafting<br>* coronary artery bypass graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR) | A composite endpoint(MACE) is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Definitions for primary and secondary clinical outcomes are consistent with those used in the original BEST trial protocol(NCT00997828). | 10-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, myocardial infarction, or stroke |  | 10-year | 
| Composite of death, myocardial infarction, stroke, or any repeat revascularization |  | 10-year | 
| All-cause death |  | 10-year | 
| Myocardial infarction |  | 10-year | 
| Stroke |  | 10-year | 
| Target vessel revascularization (TVR) |  | 10-year | 
| Any repeat revascularization |  | 10-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multivessel coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft