Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Emory University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the study is to find out if hybrid coronary revascularization (HCR) and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
Detailed Description
Currently, it is not clear how the outcomes of hybrid coronary revascularization (HCR) compare with other treatments. The purpose of the study is to find out if HCR and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries. This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).
Investigators
Michael Halkos
Associate Professor of Surgery
Emory University
Eligibility Criteria
Inclusion Criteria
- •Able to give informed consent
- •Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
- •Have a clinical indication for revascularization
- •Are a candidate for either HCR or CABG or both
- •Anatomy suitable for HCR shall include
- •Multi-vessel CAD involving the LAD and/or
- •LAD disease and involvement of a major diagonal artery, both of which require revascularization
Exclusion Criteria
- •Prior cardiac operations
- •Severe left ventricular dysfunction with ejection fraction (EF) \< 30%
- •Patients with chest radiation
- •Body mass index (BMI) \> 35
- •Severe peripheral vascular disease (PVD)
- •Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
Outcomes
Primary Outcomes
Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
Time Frame: Up to one year
Major adverse cardiac and cerebrovascular events (MACCE) will be assessed at 30 days and at one year after the index procedure. For the purpose of this trial, the components of MACCE include (1) all-cause mortality, (2) repeat revascularization, (3) stroke, and (4) myocardial infarction.
Secondary Outcomes
- Comparison of repeat revascularization between groups(Up to one year)
- Comparison of atrial fibrillation between groups(During hospitalization (typically 3-8 days))
- Comparison of ventilator time between groups(During hospitalization (typically 3-8 days))
- Comparison of chest tube drainage complications between groups(During hospitalization (typically 3-8 days))
- Comparison of hospital length of stay between groups(During hospitalization (typically 3-8 days))
- Comparison of Angina Score between groups(Up to one year)
- Comparison of Duke Activity Scale Index (DASI) scores between groups(Up to one year)
- Comparison of all-cause mortality between groups(Up to one year)
- Comparison of ischemia-driven repeat revascularization between groups(Up to one year)
- Comparison of wound infection between groups(During hospitalization (typically 3-8 days))
- Comparison of hospital readmission between groups(Up to one year)
- Comparison of stroke between groups(Up to one year)
- Comparison of surgical re-exploration between groups(During hospitalization (typically 3-8 days))
- Comparison of blood transfusion between groups(During hospitalization (typically 3-8 days))
- Comparison of EuroQol EQ-5D scores between groups(Up to one year)