The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial

Study Overview
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Brief Summary
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MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.

Official Title
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The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: MICS CABG
* Procedure: Conventional CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% in at least 2 major epicardial vessels in 2 or more coronary artery territories (left anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions >=50% in the left main (LM) Patients who, in the opinion of the investigator, are amenable for coronary surgery through either median sternotomy or minimally-invasive approach. Patients who are willing and able to comply with all follow-up study visits. Exclusion Criteria: <18 years of age concomitant cardiac procedure with CABG (e.g. valve repair or replacement) Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence of femoral pulse bilaterally. Contraindications for conventional CABG via sternotomy Concomitant life-threatening disease likely to limit life expectancy to <2 years Emergency CABG with hemodynamic compromise Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG with sternotomy<br>Patients in this group will undergo coronary artery bypass grafting (CABG) in the usual way, through an incision in the middle of the chest, through the breastbone or sternum (conventional CABG). | Procedure: Conventional CABG<br>* Coronary artery bypass grafting performed through an incision through the sternum or breastbone.<br>* Other names: coronary artery bypass grafting via sternotomy;|
| Experimental: Minimally-invasive CABG<br>Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs. | Procedure: MICS CABG<br>* Coronary artery bypass grafting performed through small incisions between the ribs.<br>* Other names: Minimally invasive coronary artery bypass grafting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life - physical function | Comparison of the physical quality of life between the two groups four weeks after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions. | 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR) | A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia. | Through study completion, an average of 1 year after surgery. | 
| Number of bypass grafts | A comparison of the mean number of bypass grafts performed between the two groups | During coronary artery bypass surgery | 
| Percentage of arterial grafts | A comparison of the percentage of bypass grafts that are arterial between the groups | During coronary artery bypass surgery | 
| Intra-operative transfusion | A comparison of the number of transfusions during surgery between the groups | During coronary artery bypass surgery | 
| Post-operative transfusion | A comparison of the number of transfusions after surgery between the groups | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Re-exploration for bleeding | The incidence of re-exploration for bleeding after surgery | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Post-operative pain | Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Duration of intubation | Comparison of the average duration of intubation between groups | Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours. | 
| Length of ICU stay | Comparison of the average number of days spent in Intensive Care Unit between groups | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Length of hospital stay | Comparison of the average number of days spent in hospital between groups | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Atrial fibrillation | Incidence of new-onset atrial fibrillation after cardiac surgery | From the time of surgery until the patient is discharged from hospital, an average of 7 days | 
| Wound infection | Incidence of wound infections in each group | During the first 2 months after surgery | 
| Angina | Prevalence of anginal symptoms, as measured by the Seattle Angina Questionnaire. The SAQ includes scales that measure physical limitation, stability of angina, frequency of angina, satisfaction with treatment, and perception of disease, each of which is measured on a scale of 0 to 100 where higher scores indicate better function or health. | 4 weeks after surgery | 
| Quality of Life - mental function | Comparison of the mental quality of life between the two groups four weeks after surgery using the mental component score of the 36-Item Short Form Health Survey (SF-36). The mental function score is a scale from 0 (poor mental quality of life) to 100 (excellent mental quality of life), with an average score of 50. It includes items that assess vitality, general health perceptions, emotional role functioning, social role functioning, and mental health. | 4 weeks after surgery |