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

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Samsung Medical Center

Status

Enrolling

Conditions

Ischemic Heart Disease

Treatments

Procedure: PCI
Procedure: CABG

Study type

Observational

Funder types

Other

Identifiers

NCT03870815
CABG2019

Details and patient eligibility

About

  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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years

Trial design

10,000 participants in 2 patient groups

CABG
Description:
Patients with CAD who undergoing CABG
Treatment:
Procedure: CABG
PCI
Description:
Patients with CAD who undergoing PCI with DES
Treatment:
Procedure: PCI

Trial contacts and locations

1

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Central trial contact

Ki Hong Choi, MD; Young Bin Song, MD, PhD

Data sourced from clinicaltrials.gov

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