Clinical trial NCT05121610: Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)
Official title: Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: PCI
CABG
HCR
Complex coronary artery disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 2864
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complex coronary artery disease

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).


Eligibility criteria: Inclusion Criteria:

1. Male/female aged 18-80 years;
2. Having complex coronary artery disease (SYNTAX score \> 22 points) undergoing myocardial revascularization

Exclusion Criteria:

1. Cardiogenic shock or hemodynamic instability;
2. Undergoing other heart surgery at the same time;
3. Previous coronary artery bypass surgery;
4. History of cerebral hemorrhage;
5. Ischemic stroke in the past six months;
6. History of cancer;
7. Life expectancy no more than 12 months

Primary outcomes:
measure: MACCE
timeFrame: 1 year
Secondary outcomes:
measure: All cause death
timeFrame: 1 year
measure: Cardiovascular death
timeFrame: 1 year
measure: Non-fatal myocardial infarction
timeFrame: 1 year
measure: Ischemia-driven revascularization
timeFrame: 1 year
measure: Non-fatal stroke
timeFrame: 1 year
measure: The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization
timeFrame: 1 year
measure: The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
timeFrame: 1 year
measure: The composite endpoints including cardiovascular death or nonfatal myocardial infarction
timeFrame: 1 year
measure: All bleeding events defined by the BARC bleeding criteria
timeFrame: 1 year
measure: Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Dongmei Shi
role: PRINCIPAL_INVESTIGATOR
References: