HCR vs. CABG Study

Emory University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary Artery Bypass Grafting (CABG); Procedure: Hybrid Coronary Revascularization (HCR)

Study type: Observational

Funder types: Other

Identifiers

NCT02892474

IRB00089868

Details and patient eligibility

About

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.

Full 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).

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

75 participants in 2 patient groups

Hybrid Coronary Revascularization (HCR)

Description:

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.

Treatment:

Procedure: Hybrid Coronary Revascularization (HCR)

Coronary Artery Bypass Grafting (CABG)

Description:

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.

Treatment:

Procedure: Coronary Artery Bypass Grafting (CABG)