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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870815
• Other study ID #: CABG2019
• Status: Recruiting
• Start date: February 27, 2019
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: Young Bin Song, MD, PhD
• Phone: 82-2-3410-3419
• Email: youngbin.song[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• CABG
Patients who undergoing CABG
• PCI
Patients who undergoing PCI with DES

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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