HCR vs. CABG Study
Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease
1 other identifier
observational
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 2, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedOctober 2, 2019
October 1, 2019
2 years
September 2, 2016
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
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.
Up to one year
Secondary Outcomes (15)
Comparison of all-cause mortality between groups
Up to one year
Comparison of repeat revascularization between groups
Up to one year
Comparison of stroke between groups
Up to one year
Comparison of ischemia-driven repeat revascularization between groups
Up to one year
Comparison of ventilator time between groups
During hospitalization (typically 3-8 days)
- +10 more secondary outcomes
Study Arms (2)
Hybrid Coronary Revascularization (HCR)
Patients who are scheduled to have the hybrid coronary revascularization (HCR) procedure for treatment of multi-vessel coronary artery disease. The treatment plan is determined by the patient's doctor.
Coronary Artery Bypass Grafting (CABG)
Patients who are scheduled to have the coronary artery bypass grafting (CABG) procedure for treatment of multi-vessel coronary artery disease. The treatment plan is determined by the patient's doctor.
Interventions
Hybrid coronary revascularization (HCR) is a combination of surgery and catheter procedures to open up clogged heart arteries. HCR is the intentional combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with PCI of non-LAD coronary stenoses. Drug-eluting stents are substituted for saphenous vein grafts (SVG) for non-LAD coronary targets, and the surgical LIMA to LAD bypass is performed, ideally through a minimally invasive, limited access, sternal-sparing approach.
Coronary artery bypass grafting (CABG) is a surgery to create a new path for blood flow to the heart. A healthy section of vein or artery from elsewhere in the patient's body will be attached to the coronary artery just above and below the area of concern, to create a way for blood to bypass the blocked part of the coronary artery.
Eligibility Criteria
The patient population for this trial consists of adult patients with multi-vessel coronary artery disease who are being treated with either hybrid coronary revascularization (HCR) or coronary artery bypass grafting (CABG), as determined by their doctor.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Halkos, MD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
September 2, 2016
First Posted
September 8, 2016
Study Start
August 1, 2016
Primary Completion
July 27, 2018
Study Completion
July 27, 2018
Last Updated
October 2, 2019
Record last verified: 2019-10