Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)

Study Overview
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Brief Summary
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Coronary heart disease is one of the most serious diseases that endanger people's health. Complex coronary artery disease is critical and has high mortality. Therefore, it is urgent to explore the best treatment method for complex coronary artery disease. Some previous studies have shown that patients with left main coronary artery disease with a SYNTAX score> 32 points, and diabetic/non-diabetic three-vessel disease patients with coronary heart disease with a SYNTAX score > 22 points, CABG is recommended for revascularization. However, with the continuous innovation of surgical technology and the rapid development of surgical instruments, the treatment of patients with complex coronary artery disease is increasing. Therefore, it is necessary to investigate the effects of different revascularization strategies on long-term prognosis in patients with complex coronary artery disease (SYNTAX score > 22 points).

Official Title
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Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: The procedures include PCI, CABG and HCR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female aged 18-80 years; Having complex coronary artery disease (SYNTAX score > 22 points) undergoing myocardial revascularization Exclusion Criteria: Cardiogenic shock or hemodynamic instability; Undergoing other heart surgery at the same time; Previous coronary artery bypass surgery; History of cerebral hemorrhage; Ischemic stroke in the past six months; History of cancer; Life expectancy no more than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 group<br>CABG group | Procedure: The procedures include PCI, CABG and HCR<br>* The procedures include PCI, CABG and HCR<br>|
| HCR group<br>HCR group | Procedure: The procedures include PCI, CABG and HCR<br>* The procedures include PCI, CABG and HCR<br>|
| PCI group<br>PCI group | Procedure: The procedures include PCI, CABG and HCR<br>* The procedures include PCI, CABG and HCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Major adverse cardiovascular and cerebrovascular events (MACCE) at 1 year, including all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, and non-fatal stroke | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | All-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes. | 1 year | 
| Cardiovascular death | Cardiovascular death | 1 year | 
| Non-fatal myocardial infarction | Non-fatal myocardial infarction | 1 year | 
| Ischemia-driven revascularization | Ischemia-driven revascularization | 1 year | 
| Non-fatal stroke | Stroke is defined as a neurological deficit with symptoms or signs that last at least 24 hours and imaging studies (CT or MRI) confirm the presence of cerebral infarction or cerebral hemorrhage. | 1 year | 
| The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization | The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization | 1 year | 
| The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke | The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke | 1 year | 
| The composite endpoints including cardiovascular death or nonfatal myocardial infarction | The composite endpoints including cardiovascular death or nonfatal myocardial infarction | 1 year | 
| All bleeding events defined by the BARC bleeding criteria | All bleeding events defined by the BARC bleeding criteria | 1 year | 
| Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria | Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, CABG, Complex coronary artery disease, HCR