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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Coronary Revascularization | Experimental | 2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI) |
|
| Coronary Artery Bypass Grafting (CABG) | Active Comparator | Coronary Artery Bypass Grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Artery Bypass Graft | Procedure | Coronary Artery Bypass Graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Length of Stay | Number of days from end of surgery to hospital discharge | From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to sternotomy / CABG | Rate of intraoperative conversion from RA-MIDCAB to sternotomy CABG (%) | From beginning of surgery time to end of surgery time (skin to skin) |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation duration | Time to extubation post surgery measured in hours | From end of surgery time to extubation time |
| ICU length of stay | Time spent in ICU post-surgery measured in hours |
Inclusion Criteria:
Multi-vessel CAD with an indication for revascularization,
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:
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
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| Robotically-assisted minimally-invasive direct coronary artery bypass | Procedure | Robotically-assisted minimally-invasive direct coronary artery bypass |
|
|
| Percutaneous Coronary Intervention | Procedure | Percutaneous Coronary Intervention |
|
|
| From end of surgery time to ICU discharge time, assessed up to 10 days |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D057510 | Endovascular Procedures |
| D019060 | Minimally Invasive Surgical Procedures |
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