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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: The procedures include PCI, CABG and HCR

• Study Type: Observational
• Enrollment (Anticipated): 2864

Contacts and Locations

• Study Contact: Name: Miao Yu, Doctor; Phone Number: 13811879285; Email: evelynym@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with complex coronary artery disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CABG group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR
HCR group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR
PCI group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Dongmei Shi, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: PCI; CABG; Complex coronary artery disease; HCR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: EDGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No