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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- MACCE
Study Overview
Brief Summary
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.
Detailed Description
Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:
- 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).
- OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.)
Outcomes
Primary Outcomes
MACCE
Time Frame: up to 3 years
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause. From cardiovascular causes. From noncardiovascular causes. Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.
Secondary Outcomes
- Procedural success(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Transfusion rate(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Recovery time(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- New York Heart Association (NYHA) class modification with respect to baseline(up to 3 years)
- Wound infection(up to 12 months postoperatively)
- New-onset renal failure(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Respiratory insufficiency(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Return to full physical activity postoperatively(up to 3 years)
- Intensive care unit (ICU) stay(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
Investigators
Aliaksandr A Ziankou
Chief of the cardiac surgery department of the VitebskRCH
Vitebsk Regional Clinical Hospital