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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- Samsung Medical Center
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Cardiac Death
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
- To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
- 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.
Investigators
Young Bin Song
Associate Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients who suspected ischemic heart disease and underwent CABG or PCI with DES
Exclusion Criteria
- •Age \< 18 years
Outcomes
Primary Outcomes
Cardiac Death
Time Frame: 5-Year after the index procedure
death from cardiac-cause
Secondary Outcomes
- All-cause Death(5-Year after the index procedure)
- MACCE (major adverse cardiac and cerebrovascular accident)(5-Year after the index procedure)
- Myocardial infarction(5-Year after the index procedure)
- Target-vessel revascularization(5-Year after the index procedure)
- Bleeding(5-Year after the index procedure)
- Cerebrovascular accident(5-Year after the index procedure)
- Any revascularization(5-Year after the index procedure)