Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: The procedures include PCI, CABG and HCR
- Registration Number
- NCT05121610
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2864
- Male/female aged 18-80 years;
- Having complex coronary artery disease (SYNTAX score > 22 points) undergoing myocardial revascularization
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CABG group The procedures include PCI, CABG and HCR CABG group HCR group The procedures include PCI, CABG and HCR HCR group PCI group The procedures include PCI, CABG and HCR PCI group
- Primary Outcome Measures
Name Time Method MACCE 1 year 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
- Secondary Outcome Measures
Name Time Method The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 1 year The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
All cause death 1 year All-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes.
The composite endpoints including cardiovascular death or nonfatal myocardial infarction 1 year The composite endpoints including cardiovascular death or nonfatal myocardial infarction
Cardiovascular death 1 year Cardiovascular death
The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization 1 year The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization
All bleeding events defined by the BARC bleeding criteria 1 year All bleeding events defined by the BARC bleeding criteria
Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria 1 year Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria
Non-fatal myocardial infarction 1 year Non-fatal myocardial infarction
Non-fatal stroke 1 year 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.
Ischemia-driven revascularization 1 year Ischemia-driven revascularization