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

July 15, 2018 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital-based, full-service hospitals with capability of both PCI and CABG surgery in addition to cardiac catheterization

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CABG surgery
Candidates for CABG surgery for left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis indicated by current practice guideline
Procedure: CABG surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery
Time Frame: 1 month (After the revascularization strategy was finally decided)
1 month (After the revascularization strategy was finally decided)

Secondary Outcome Measures

Outcome Measure
Time Frame
Reason of ineligibility for CABG surgery
Time Frame: 1 month (After the revascularization strategy was finally decided)
1 month (After the revascularization strategy was finally decided)
the composite of major cardiac and cerebrovascular event (MACCE)
Time Frame: 1 year follow up after revascularization
1 year follow up after revascularization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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