Text Size

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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborators:
Abbott Vascular
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00997828
First received: October 18, 2009
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
 Device: everolimus-eluting stent
Procedure: coronary artery bypass graft surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    Death includes all cause mortality. MI includes both Q wave and non Q wave, per protocol definition. TVR should be defined by the protocol.


Secondary Outcome Measures:
  • the composite of death, myocardial infarction, and any target vessel revascularization [ Time Frame: at 2years ] [ Designated as safety issue: Yes ]
  • Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • MACCE (The composite of death, MI, stroke and any TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • the composite of death, MI, and any TVR [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic MACE(the composite of death, MI, and any TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • all cause death [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • cardiac death [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 3o days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic-driven TVR [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • any target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • any target vessel revascularization or target lesion revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • non-target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • analysis segment and in-stent binary restenosis [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • analysis segment and in-stent late loss [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • angina status [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cardiac re-hospitalizations [ Time Frame: at 1 years and yearly to 5 years ] [ Designated as safety issue: No ]
  • Quality of life measurements [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • use of cardiac medications [ Time Frame: at 1 year and yearly to 5 years ] [ Designated as safety issue: No ]
  • Dialysis/hemofiltration [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • Infectious complications [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
  • duration of hospitalization related to the target procedure [ Time Frame: at every event time ] [ Designated as safety issue: No ]
  • 2-year MACE according to the use of FFR-guided multivessel PCI [ Time Frame: at 2 years after index procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1776
Study Start Date: July 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus-eluting stent
everolimus-eluting stent
 Device: everolimus-eluting stent
Xience V stent
Other Name: everolimu-eluting stent
Active Comparator: coronary artery bypass graft surgery
coronary artery bypass graft surgery
 Procedure: coronary artery bypass graft surgery
coronary artery bypass graft surgery
Other Name: coronary artery bypass graft surgery

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997828

Contacts
Contact: Seung-Jung Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr
Contact: Young-Hak Kim, MD, PhD

Locations
China
Sir Run Run Shaw Hospital Active, not recruiting
Hangzhou, China
Zhongshan Hospital Active, not recruiting
Shanghai, China
Hong Kong
Queen Elizabeth Hospital Active, not recruiting
Hong Kong, Hong Kong
Korea, Republic of
Dankook University Hospital Recruiting
Chunahn, Korea, Republic of
Contact: Myeon-Yong Lee, MD, PhD            
Dong-A University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: MH Kim, MD,PhD            
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD, PhD            
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD            
GangNeung Asan Hospital Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD            
Principal Investigator: Sang-Sig Cheong, MD, PhD            
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Myung Ho Jung, MD, PhD            
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Keum Soo Kim, MD,PhD            
Principal Investigator: Keum Soo Kim, MD,PhD            
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Ki Ko, MD, PhD            
Principal Investigator: Jae-Ki Ko, MD, PhD            
Gyeongsang National University Hospital Recruiting
Jinju, Korea, Republic of
Contact: Young-Hoon Jeong, MD,PhD            
Principal Investigator: Young-Hoon Jeong, MD,PhD            
Bundang CHA Hospital Recruiting
Seongnam, Korea, Republic of
Contact: S.W Lim , MD            
Principal Investigator: S.W. Lim, MD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD, PhD     (82-2)-3010-4812     sjpark@amc.seoul.kr    
Principal Investigator: Seung-Jung Park, MD, PhD            
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: H.M. Kwon, MD            
Principal Investigator: H.M. Kwon, MD, PhD            
Hanyang National University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: K.S. Kim, MD,PhD            
Principal Investigator: KS Kim, MD,PhD            
Malaysia
National Heart Institue Active, not recruiting
Kuala Lumpur, Malaysia
Sarawak General Hospital Recruiting
Kuching, Malaysia
Contact: K.H. Shim            
Principal Investigator: K.H. Shim            
Thailand
Siriraj Hospital Active, not recruiting
Bangkok, Thailand
Ramathibodi Hospital Active, not recruiting
Bangkok, Thailand
Sponsors and Collaborators
Seung-Jung Park
Abbott Vascular
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00997828     History of Changes
Other Study ID Numbers: 2008-0272
Study First Received: October 18, 2009
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Coronary Artery Disease
stent
coronary artery bypass graft surgery
multivessel coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013