HCR vs. CABG Study

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary Artery Bypass Grafting (CABG); Procedure: Hybrid Coronary Revascularization (HCR)

• Registration Number: NCT02892474
• Lead Sponsor: Emory University

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).

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Primary Completion: 2018-07-27
• Study Completion: 2018-07-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Bypass Grafting (CABG)	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.
Hybrid Coronary Revascularization (HCR)	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.

Primary Outcome Measures

Name	Time	Method
Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups	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 Outcome Measures

Name	Time	Method
Comparison of repeat revascularization between groups	Up to one year	Repeat revascularization (all-cause) will be assessed at 30 days and at one year after the index procedure.
Comparison of atrial fibrillation between groups	During hospitalization (typically 3-8 days)	The incidence of atrial fibrillation will be collected during the index hospitalization.
Comparison of ventilator time between groups	During hospitalization (typically 3-8 days)	The amount of time each patient spends on a ventilator during the index hospitalization will be collected.
Comparison of chest tube drainage complications between groups	During hospitalization (typically 3-8 days)	Chest tube drainage complications will be collected during the index hospitalization.
Comparison of hospital length of stay between groups	During hospitalization (typically 3-8 days)	Hospital length of stay will be collected during the index hospitalization.
Comparison of Angina Score between groups	Up to one year	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
Comparison of Duke Activity Scale Index (DASI) scores between groups	Up to one year	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.
Comparison of all-cause mortality between groups	Up to one year	All-cause mortality will be assessed at 30 days and at one year after the index procedure.
Comparison of ischemia-driven repeat revascularization between groups	Up to one year	The incidence of ischemia-driven revascularization experienced between the groups will be assessed at 30 days and at one year after the index procedure.
Comparison of wound infection between groups	During hospitalization (typically 3-8 days)	The incidence of wound infection will be collected during the index hospitalization.
Comparison of hospital readmission between groups	Up to one year	Hospital readmission (all-cause and cardiac) will be assessed at 30 days and at one year after the index procedure.
Comparison of stroke between groups	Up to one year	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.
Comparison of surgical re-exploration between groups	During hospitalization (typically 3-8 days)	The incidence of re-exploration due to postoperative bleeding will be collected during the index hospitalization.
Comparison of blood transfusion between groups	During hospitalization (typically 3-8 days)	The incidence of blood transfusions will be collected during the index hospitalization.
Comparison of EuroQol EQ-5D scores between groups	Up to one year	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).

Trial Locations

Locations (1)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States