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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belarus
  • Vitebsk region
    • Vitebsk, Vitebsk region, Belarus, 210037
      • Recruiting
      • Vitebsk Regional Clinical Hospital
      • Contact: Mikalai G Laiko, MD; Phone Number: +375333050458; Email: Nikolay99@mail.ru
      • Contact: Aliaksandr A Ziankou, MD, PhD
      • Principal Investigator: Aliaksandr A Ziankou, MD, PhD
      • Sub-Investigator: Mikalai G Laiko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: MICS CABG; Minimally invasive coronary artery bypass grafting - beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral left mini-thoracotomy. The left internal thoracic artery is used to graft the left anterior descending artery or circumflex artery territories. Radial artery or saphenous vein are used (Y - grafts) to graft another myocardial territories. Right internal thoracic artery can be used as free Y-graft, as in-situ graft with radial artery (extension technique) or as in-situ graft without composite technique. Right gastroepiploic artery can be used to graft right coronary artery territory. Hybrid approach (MICS CABG + PCI), parallel transfemoral extracorporeal circulation without cardioplegia and CABG from the ascending aorta are acceptable for achievement of the complete revascularization.; Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®); Octopus® Nuvo - MICS CABG tissue stabilizer available for minimally invasive procedures. It minimizes the motion of a small area of the heart while the rest of the heart continues to beat normally and allows to perform anastomosis through a small incision. Starfish® Non-Sternotomy (NS) - MICS CABG heart positioner available for minimally invasive procedures. It allows for the positioning of the beating heart through a small incision, bringing coronary targets into the operative thoracotomy window. ThoraTrak® - a reusable, stainless steel MICS thoracic retractor system for minimally invasive heart surgery with multiple interchangeable blades, which allows to harvest left internal thoracic artery and to perform anastomosis through a small left thoracotomy(Medtronic, Inc., Minneapolis, MN).; Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt; Starfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN)
Active Comparator: 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)	Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt; Starfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN); Procedure: OPCABG; Off-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Mechanical Devices are used for coronary artery stabilization and heart positioning. Pericardial traction sutures are used to position the heart where appropriate. Blowers and Intracoronary shunts are used routinely. Anticoagulation is obtained using sodium heparin at a dose of 2mg/kg with supplemental doses to maintain adequate heparinisation (Activated clotting time>250seconds).
Active Comparator: ONCABG; On-pump coronary artery bypass grafting treatment (ONCABG group, n=50)	Procedure: ONCABG; On-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Normothermic cardiopulmonary bypass and complex blood ante-retrograde cardioplegia are used. All patients are cannulated with an proximal aortic cannula and two-stage right atrial cannula. Extracorporeal circulation is provided by the Terumo System-1 heart-lung machine using cardiopulmonary bypass systems with physiological surfaces and opened venous reservoirs. The left internal thoracic artery is used to graft the left anterior descending artery, and radial artery or saphenous vein segments are used to graft another myocardial territories. Anticoagulation is obtained using sodium heparin at a dose of 3mg/kg (ACT, activated clotting time>450seconds).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	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.	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	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.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Transfusion rate	Proportion of patients who received at least one transfusion of any blood product	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery time	Length of postoperative hospital stay from the end of the intervention up to discharge from the hospital	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	Drainage of purulent material from the wound (superficial or deep)	up to 12 months postoperatively
New-onset renal failure	The need for temporary or permanent renal dialysis of any type	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Respiratory insufficiency	Cumulative requirement for intubation and ventilation of 72 h or more, at any time during the postoperative stay	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Return to full physical activity postoperatively	(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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural and post-procedural blood loss	blood loss during operation and first twenty-four hours postoperatively	up to first twenty-four hours postoperatively

Collaborators and Investigators

• Sponsor: Vitebsk Regional Clinical Hospital
• Investigators: Principal Investigator: Aliaksandr A Ziankou, MD, PhD, Vitebsk Regional Clinical Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: January 19, 2014
• First Submitted That Met QC Criteria: January 25, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 19, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: MICS CABG OPCABG ONCABG CAD
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: MICSREVS