Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting (MICS CABG) Versus Off Pump (OPCABG) and on Pump Coronary Artery Bypass Grafting (ONCABG) in Patients With Multi-vessel Coronary Disease

The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.

The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.

Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:

1. MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy). (MICS CABG group, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days, 12 months and 3-year follow-up.

The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart Association (NYHA)), Life quality assessed by one of the life quality questionnaires.

Inclusion Criteria:

• Multi-vessel coronary artery disease with ≥ 70% artery stenosis (according to QCA)
• II-IV Canadian Cardiovascular Society functional class of angina
• Patients at 1 month after acute myocardial infarction
• Ability to perform either of revascularization methods (MICS CABG, OPCABG, ONCABG)
• Patients must have signed an informed consent

Exclusion Criteria:

• Pregnancy.
• Acute coronary syndrome.
• Previous CABG.
• Severe comorbidity with high procedural risk for either of the studied strategies.
• Mental diseases which block the revascularization procedure.
• Severe peripheral artery disease.
• Other serious diseases limiting life expectancy (e.g. oncology)
• Inability for long-term follow-up.
• Participation in other clinical trials.
• Single vessel disease.
• Need for emergency revascularization (Acute MI, Acute coronary syndrome etc.)