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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Procedure: CABG
* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who suspected ischemic heart disease and underwent CABG or PCI with DES Exclusion Criteria: Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CABG<br>Patients with CAD who undergoing CABG | Procedure: CABG<br>* Patients who undergoing CABG<br>|
| PCI<br>Patients with CAD who undergoing PCI with DES | Procedure: PCI<br>* Patients who undergoing PCI with DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death | death from cardiac-cause | 5-Year after the index procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic heart disease, Coronary artery bypass grafting, Percutaneous coronary intervention