Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

Vitebsk Regional Clinical Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases

Treatments: Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®); Procedure: OPCABG; Procedure: ONCABG; Procedure: MICS CABG; Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT02047266

MICSREVS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

MICS CABG

Experimental group

Description:

Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy), which is performed with a help of Octopus® Nuvo, Starfish® Non-Sternotomy, ThoraTrak®, Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (MICS CABG group, n=50)

Treatment:

Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)

Procedure: MICS CABG

Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt

OPCABG

Active Comparator group

Description:

Off-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (OPCABG group, n=50)

Treatment:

Procedure: OPCABG

Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt

ONCABG

Active Comparator group

Description:

On-pump coronary artery bypass grafting treatment (ONCABG group, n=50)

Treatment:

Procedure: ONCABG