Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments everolimus-eluting stent, coronary artery bypass graft surgery
Phase phase 4
Sponsor Seung-Jung Park
Collaborator Abbott Vascular
Start date July 2009
End date May 2016
Trial size 888 participants
Trial identifier NCT00997828, 2008-0272

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
everolimus-eluting stent
everolimus-eluting stent everolimu-eluting stent
Xience V stent
(Active Comparator)
coronary artery bypass graft surgery
coronary artery bypass graft surgery
coronary artery bypass graft surgery

Primary Outcomes

Measure
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
time frame: at 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)
Principal investigator Seung-Jung Park, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.