HCR vs. CABG Study

Coronary Artery Disease Clinical Trial

Official title:

Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892474
• Other study ID #: IRB00089868
• Status: Completed
• Start date: August 2016
• Est. completion date: July 27, 2018

Study information

• Verified date: October 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

1. Multi-vessel CAD involving the LAD and/or

2. 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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Hybrid Coronary Revascularization (HCR)
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)
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.

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of all-cause mortality between groups	All-cause mortality will be assessed at 30 days and at one year after the index procedure.	Up to one year
Secondary	Comparison of repeat revascularization between groups	Repeat revascularization (all-cause) will be assessed at 30 days and at one year after the index procedure.	Up to one year
Secondary	Comparison of stroke between groups	The incidence and severity of strokes experienced between the groups will be assessed at 30 days and at one year after the index procedure, using the NIH Stroke Scale (NIHSS). The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete.	Up to one year
Secondary	Comparison of ischemia-driven repeat revascularization between groups	The incidence of ischemia-driven revascularization experienced between the groups will be assessed at 30 days and at one year after the index procedure.	Up to one year
Secondary	Comparison of ventilator time between groups	The amount of time each patient spends on a ventilator during the index hospitalization will be collected.	During hospitalization (typically 3-8 days)
Secondary	Comparison of surgical re-exploration between groups	The incidence of re-exploration due to postoperative bleeding will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of chest tube drainage complications between groups	Chest tube drainage complications will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of hospital length of stay between groups	Hospital length of stay will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of wound infection between groups	The incidence of wound infection will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of atrial fibrillation between groups	The incidence of atrial fibrillation will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of blood transfusion between groups	The incidence of blood transfusions will be collected during the index hospitalization.	During hospitalization (typically 3-8 days)
Secondary	Comparison of hospital readmission between groups	Hospital readmission (all-cause and cardiac) will be assessed at 30 days and at one year after the index procedure.	Up to one year
Secondary	Comparison of Angina Score between groups	Angina will be assessed at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure.; The Canadian Cardiovascular Society Angina Grading Scale will be used to categorize angina: Class I - Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II - Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress or only during the few hours after awakening; Class III - Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV - Inability to carry on a physical activity without discomfort - angina syndrome may be present at rest	Up to one year
Secondary	Comparison of Duke Activity Scale Index (DASI) scores between groups	The Duke Activity Scale Index (DASI) will be administered at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure. The DASI is a 12 item survey that asks about a patient's functional capacity in order to estimate peak oxygen uptake. Respondents answer "yes" or "no" to questions about their ability to do activities of different intensity levels.	Up to one year
Secondary	Comparison of EuroQol EQ-5D scores between groups	The EuroQol EQ-5D will be administered at Baseline (prior to surgery), 30 days after the procedure, and at one year after the index procedure. The EuroQol EQ-5D is a 6 item survey that asks about how a patient is feeling on the day of the survey in terms of mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and how they rate their health on a scale of 0 to 100 (where 0 is the worst health imaginable and 100 is the best health imaginable).	Up to one year