Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02410993
• Other study ID #: 4-2015-0063
• Status: Recruiting
• Start date: April 2015
• Est. completion date: March 2020

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: Myeong Ki Hong, MD, PhD
• Phone: 82-2-2228-8460
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was recommended for three-vessel coronary artery disease and left main coronary artery disease in the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior descending artery stenosis was also indicated for CABG surgery as class I recommendation. However, many patients have been recommended for PCI by catheterization laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real practice in catheterization laboratory and guideline would be adjusted by recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have been getting toward more PCI and less CABG surgery. In this study, we will identify the rate of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in different from current guideline. We are also going to compare two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients = 19 years old

• Left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis.

Exclusion Criteria:

• Previous PCI within 1 year

• Previous sternotomy

• Primary PCI for STEMI

• Contraindication or hypersensitivity to anti-platelet medications or contrast media

• Planned need for concomitant other cardiac surgery (eg, valve surgery or resection of aortic or left ventricular aneurysm, etc)

• Pregnant women or women with potential childbearing

• Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

• Inability to understand or read the informed content

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• CABG surgery

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery		1 month (After the revascularization strategy was finally decided)
Secondary	Reason of ineligibility for CABG surgery		1 month (After the revascularization strategy was finally decided)
Secondary	the composite of major cardiac and cerebrovascular event (MACCE)		1 year follow up after revascularization