Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics (LIBERTI)
Coronary Artery Disease, Diabetes Mellitus
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Diabetes Mellitus, Minimally Invasive Cardiac Surgery, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
- Male or Female age 18 years or older
- Diabetes Mellitus (Type 1 or Type 2) undergoing treatment
- Angiographically confirmed stenosis (≥ 70%) lesion of the proximal LAD (segment 6) or mid LAD (segment 7), with no culprit lesion or stenosis of more than 60% (in a vessel of 1.5 mm or more) in the LCX and RCA territories, and no stenosis equal or more than 50% in the left main artery. Diagonal disease does not constitute an exclusion
- Angiographic characteristics amenable to both PCI/DES and MICS CABG
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- Willing to comply with all follow-up required study visits
- Signed and received copy of informed consent
Exclusion Criteria:
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- Left ventricular ejection fraction less than 20%;
- Prior CABG surgery.
- Prior Valve surgery.
- Prior PCI with stent implantation within 6 months.
- Previous tuberculosis or trauma to the chest that may have cause adhesions or LITA damage.
- Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1.
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- In-stent restenosis in the LAD.
- Left main stenosis (50% or more).
- STEMI or Q-wave MI within 72 hours prior to enrollment
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- Contraindication to either CABG or PCI/DES because of a coexisting clinical condition.
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor.
- Dementia with a Mini Mental Status Examination (MMSE) score of <20.
- Extra-cardiac illness that is expected to limit survival to less than 5 years.
- Suspected pregnancy. A pregnancy test (urine or serum) will be administered pre-randomization to all women not clearly menopausal.
- Concurrent enrollment in another clinical trial.
- Geographically inaccessible for follow-up visits required by protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Minimally Invasive Coronary Bypass
Percutenous Coronary Intervention
Minimally invasive bypass surgery (MICS CABG) would be conducted to treat the left anterior descending (LAD) artery disease in diabetic patients. This would be a surgical intervention, and differs from the stent procedure arm.
Percutaneous coronary intervention (PCI) with drug eluting stents would be used to treat left anterior descending (LAD) artery disease in diabetic patients. This would be an intervention induced by cardiology, and differs from the surgical intervention arm.