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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03870815
Enrollment
10000
Registered
2019-03-12
Start date
2019-02-27
Completion date
2026-02-28
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Ischemic heart disease, Coronary artery bypass grafting, Percutaneous coronary intervention

Brief 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.

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.

Interventions

PROCEDUREPCI

Patients who undergoing PCI with DES

PROCEDURECABG

Patients who undergoing CABG

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Death5-Year after the index proceduredeath from cardiac-cause

Secondary

MeasureTime frameDescription
Myocardial infarction5-Year after the index procedureMyocardial infarction without peri-procedural myocardial infarction
Target-vessel revascularization5-Year after the index procedureischemia-driven or all
Any revascularization5-Year after the index procedureischemia-driven or all
All-cause Death5-Year after the index proceduredeath from any-cause
Cerebrovascular accident5-Year after the index procedureIschemic or hemorrhagic
MACCE (major adverse cardiac and cerebrovascular accident)5-Year after the index procedurea composite of death, myocardial infarction, and cerebrovascular accident
Bleeding5-Year after the index procedureBARC type 2-5

Countries

South Korea

Contacts

Primary ContactYoung Bin Song, MD, PhD
youngbin.song@gmail.com82-2-3410-3419
Backup ContactKi Hong Choi, MD
cardiokh@gmail.com82-10-8875-1648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026