NCT03870815

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
PROCEDURE	CABG	Patients who undergoing CABG
PROCEDURE	PCI	Patients who undergoing PCI with DES

Timeline

• Start date: 2019-02-27
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2019-03-12
• Last updated: 2023-04-12

Locations

1 site across 1 country: South Korea