Clinical trial NCT02892474: HCR vs. CABG Study
Official title: Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Arteriosclerosis
Hybrid Coronary Revascularization
Coronary Artery Bypass Grafting
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

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

  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)

Primary outcomes:
measure: Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
timeFrame: Up to one year
Secondary outcomes:
measure: Comparison of all-cause mortality between groups
timeFrame: Up to one year
measure: Comparison of repeat revascularization between groups
timeFrame: Up to one year
measure: Comparison of stroke between groups
timeFrame: Up to one year
measure: Comparison of ischemia-driven repeat revascularization between groups
timeFrame: Up to one year
measure: Comparison of ventilator time between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of surgical re-exploration between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of chest tube drainage complications between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of hospital length of stay between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of wound infection between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of atrial fibrillation between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of blood transfusion between groups
timeFrame: During hospitalization (typically 3-8 days)
measure: Comparison of hospital readmission between groups
timeFrame: Up to one year
measure: Comparison of Angina Score between groups
timeFrame: Up to one year
measure: Comparison of Duke Activity Scale Index (DASI) scores between groups
timeFrame: Up to one year
measure: Comparison of EuroQol EQ-5D scores between groups
timeFrame: Up to one year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Halkos, MD
role: PRINCIPAL_INVESTIGATOR
References: