Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI

April 10, 2023 updated by: Young Bin Song, Samsung Medical Center

Registry for Long-term Clinical Outcomes and Prognostic Factors in Patient With Coronary Artery Disease Undergoing Coronary Artery Bypass Graft Surgery or Percutaneous Coronary Intervention With Second Generation Drug-Eluting Stent

  1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
  2. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stent.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease (CAD) still remains one of the world's leading causes of death, despite markedly improvement of devices and technologies on past several decades. The treatment strategy for CAD included medical treatment, percutaneous coronary intervention (PCI), and coronary-artery bypass grafting (CABG). CABG is a procedure in which autologous arteries or veins are used as grafts to bypass coronary arteries that are partially or completely obstructed by atherosclerotic plaque. During the past decade, there has been nearly a 30% decline in CABG procedures, despite abundant evidence to support the effectiveness and safety of the operation.This decline has been accompanied by a corresponding increase in PCI. To date, there have been numerous studies to compare the clinical outcomes between PCI and CABG for patients with CAD. Among them, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial demonstrated CABG is associated with lower incidence of major adverse cardiac and cerebrovascualr events in patients with high SYNTAX score, compared with PCI. In this regard, the current guidelines recommend that CABG is preferred method for care of stable ischemic heart disease patients with three-vessel or left main coronary artery disease. However, most randomized controlled studies do not reflect the contemporary practice, because they have been performed in the era of bare metal stents or first-generation drug-eluting stent (DES). In addition, there have been limited data regarding the prognostic factors for long-term clinical outcomes in patients undergoing PCI with DES or CABG. Therefore, the investigators sought to compare the clinical outcomes between PCI with DES or CABG, and to identify prognostic factors for long-term clinical outcomes in patients who underwent PCI with DES or CABG.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

About 10,000 patients with suspected ischemic heart disease and who underwent PCI with DES or CABG.

Description

Inclusion Criteria:

  • Patients who suspected ischemic heart disease and underwent CABG or PCI with DES

Exclusion Criteria:

  • Age < 18 years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CABG
Patients with CAD who undergoing CABG
Procedure: CABG
Patients who undergoing CABG
PCI
Patients with CAD who undergoing PCI with DES
Procedure: PCI
Patients who undergoing PCI with DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Death
Time Frame: 5-Year after the index procedure
death from cardiac-cause
5-Year after the index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Death
Time Frame: 5-Year after the index procedure
death from any-cause
5-Year after the index procedure
Myocardial infarction
Time Frame: 5-Year after the index procedure
Myocardial infarction without peri-procedural myocardial infarction
5-Year after the index procedure
Target-vessel revascularization
Time Frame: 5-Year after the index procedure
ischemia-driven or all
5-Year after the index procedure
Any revascularization
Time Frame: 5-Year after the index procedure
ischemia-driven or all
5-Year after the index procedure
Bleeding
Time Frame: 5-Year after the index procedure
BARC type 2-5
5-Year after the index procedure
Cerebrovascular accident
Time Frame: 5-Year after the index procedure
Ischemic or hemorrhagic
5-Year after the index procedure
MACCE (major adverse cardiac and cerebrovascular accident)
Time Frame: 5-Year after the index procedure
a composite of death, myocardial infarction, and cerebrovascular accident
5-Year after the index procedure

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Young Bin Song, MD, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 27, 2019

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

February 28, 2026

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABG2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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