Coronary Artery Disease, Multivessel Coronary Artery Disease
Conditions
Keywords
CABG, Hybrid Coronary Revascularization, Robotically-assisted minimally-invasive direct coronary artery bypass, RA-MIDCAB
Brief summary
The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications.
Interventions
PROCEDURECoronary Artery Bypass Graft
Coronary Artery Bypass Graft
PROCEDURERobotically-assisted minimally-invasive direct coronary artery bypass
Robotically-assisted minimally-invasive direct coronary artery bypass
PROCEDUREPercutaneous Coronary Intervention
Percutaneous Coronary Intervention
Sponsors
Cardiology Research UBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Multi-vessel CAD with an indication for revascularization, 2. Presence of at least 1 risk factor for increased risk of post-operative death or major complication, * Any patient Age \> 80, OR * Any patient with eGFR (Glomerular Filtration Rate) \< 50, OR * Any patient with LVEF \< 40%, OR * Any patient deemed to be frail by consulting surgeon. OR * Patients \> 75 years of age with at least one of the following: * Ejection fraction \< 50% * History of prior CVA (Cerebral Vascular Accident) 3. Coronary artery anatomy appropriate for a robotically-assisted MIDCAB or regular CABG, vessels other than the left anterior descending with lesions amenable to either CABG or PCI.
Exclusion criteria
1. Significant left main coronary artery disease, 2. Ejection fraction \< 30%, 3. Patients with GFR \< 30, 4. Patients unable to take dual anti-platelet agents due to high bleeding risk, 5. Patients requiring emergent surgery, including patients with hemodynamic instability, 6. Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Length of Stay | From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days | Number of days from end of surgery to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to sternotomy / CABG | From beginning of surgery time to end of surgery time (skin to skin) | Rate of intraoperative conversion from RA-MIDCAB to sternotomy CABG (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intubation duration | From end of surgery time to extubation time | Time to extubation post surgery measured in hours |
| ICU length of stay | From end of surgery time to ICU discharge time, assessed up to 10 days | Time spent in ICU post-surgery measured in hours |
Outcome results
None listed