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

Coronary Artery Disease Clinical Trial

— BEST  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00997828
• Other study ID #: 2008-0272
• Status: Terminated
• Phase: N/A
• Start date: July 28, 2008
• Est. completion date: April 5, 2019

Study information

• Verified date: May 2019
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 888
• Est. completion date: April 5, 2019
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• everolimus-eluting stent
Xience V stent

Procedure:
• coronary artery bypass graft surgery
coronary artery bypass graft surgery

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou
China	Zhongshan Hospital	Shanghai
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang National University Medical Center	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	St.carollo Hospital	Suncheon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Christian Hospital	Wonju
Malaysia	National Heart Institue	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Thailand	Siriraj Hospital	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Abbott Medical Devices, CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

China,  Korea, Republic of,  Malaysia,  Thailand, 

Outcome

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