Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

Not Applicable

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases
• Interventions: Procedure: OPCABG; Procedure: ONCABG; Procedure: MICS CABG; Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®); Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt

• Registration Number: NCT02047266
• Lead Sponsor: Vitebsk Regional Clinical Hospital

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:

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-25
• Study First Posted: 2014-01-28
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-19
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPCABG	OPCABG	Off-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (OPCABG group, n=50)
ONCABG	ONCABG	On-pump coronary artery bypass grafting treatment (ONCABG group, n=50)
MICS CABG	Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)	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)
MICS CABG	MICS CABG	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)
MICS CABG	Starfish®, Octopus®, Clearview® blower, ClearView® Shunt	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)
OPCABG	Starfish®, Octopus®, Clearview® blower, ClearView® Shunt	Off-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (OPCABG group, n=50)

Primary Outcome Measures

Name	Time	Method
MACCE	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 Outcome Measures

Name	Time	Method
Procedural success	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Procedural success: The MICS CABG treatment will be considered successful when a complete or functionally reasonable revascularisation in the absence of complications during the index hospitalization has been achieved.
Transfusion rate	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Proportion of patients who received at least one transfusion of any blood product
Recovery time	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Length of postoperative hospital stay from the end of the intervention up to discharge from the hospital
New York Heart Association (NYHA) class modification with respect to baseline	up to 3 years
Wound infection	up to 12 months postoperatively	Drainage of purulent material from the wound (superficial or deep)
New-onset renal failure	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The need for temporary or permanent renal dialysis of any type
Respiratory insufficiency	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Cumulative requirement for intubation and ventilation of 72 h or more, at any time during the postoperative stay
Return to full physical activity postoperatively	up to 3 years	(1) the ability to walk 30 min or more per day and (2) the ability to use the upper torso and arms without restriction for activities of daily living
Intensive care unit (ICU) stay	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (1)

Vitebsk regional clinical hospital; 🇧🇾 Vitebsk, Vitebsk region, Belarus