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

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: MICS CABG; Procedure: Conventional CABG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03447938

20180008

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

CABG with sternotomy

Active Comparator group

Description:

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).

Treatment:

Procedure: Conventional CABG

Minimally-invasive CABG

Experimental group

Description:

Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.

Treatment:

Procedure: MICS CABG