Minimally Invasive vs. Conventional Heart Bypass for Coronary Artery Disease

(MIST Trial)

Recruiting at 19 trial locations

Overseen By Mary Zhang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Previous cardiac surgery, severe pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of heart bypass surgery for individuals with coronary artery disease, a condition where the heart's blood vessels are blocked. One method is the conventional surgery through the middle of the chest, known as Conventional CABG (Coronary Artery Bypass Grafting). The other is a less invasive option using smaller incisions between the ribs, known as MICS CABG (Minimally Invasive Coronary Surgery). The trial aims to determine which method enables faster recovery and improves quality of life. Individuals advised to undergo heart bypass surgery with blockages in two or more major heart vessels might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative surgical options that could enhance recovery and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that minimally invasive coronary surgery is safe for coronary artery disease patients?

Research shows that MICS CABG, a less invasive heart surgery, is generally safe for people with coronary artery disease. Studies have found that this method is well-tolerated and provides excellent short-term results. Experienced surgeons performing MICS CABG achieve safety and effectiveness, with survival rates comparable to traditional surgery. Patients often regain physical function more quickly after this procedure. While all surgeries carry some risks, current evidence suggests that MICS CABG offers a promising alternative to the conventional approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about minimally-invasive coronary artery bypass grafting (MICS CABG) because it offers a less invasive approach compared to the traditional method. Unlike conventional CABG, which involves a large incision through the breastbone, MICS CABG uses smaller incisions between the ribs. This could potentially lead to faster recovery times, less pain, and fewer complications, making it an attractive option for patients with coronary artery disease. By reducing the trauma associated with surgery, MICS CABG might improve overall patient outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

This trial will compare minimally invasive coronary artery bypass grafting (MICS CABG) with conventional coronary artery bypass grafting (CABG). Studies have shown that MICS CABG can be as safe and effective as traditional heart surgery. Research indicates that patients undergoing MICS CABG often resume physical activity more quickly, typically within 7 to 30 days post-surgery. This method uses smaller incisions, which can result in less pain and faster recovery. Observational studies suggest that survival rates and long-term outcomes are similar to those of conventional heart surgery. Overall, MICS CABG offers a promising alternative with good short-term results for individuals with multiple blocked heart arteries. ^{3 4 6 7 8}

Who Is on the Research Team?

Marc Ruel, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

Adults with multi-vessel coronary artery disease suitable for bypass surgery via sternotomy or a minimally-invasive approach, who can follow the study's procedures. Excluded are those under 18, previous heart surgery patients, emergency cases, and individuals with life-threatening diseases or conditions that contraindicate the surgical methods.

Inclusion Criteria

My doctor thinks I can have heart surgery through a cut in my chest or a less invasive method.

I can attend all required follow-up visits for the study.

I have severe blockages in two or more of my heart's major arteries.

Exclusion Criteria

I cannot have traditional open-heart surgery.

I have had heart surgery, chest radiation, or major chest injury.

I am having a heart surgery along with a bypass.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo coronary artery bypass grafting (CABG) using either a minimally-invasive approach or conventional sternotomy

1 day

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery, with monitoring for transfusions, pain, and other post-operative outcomes

7 days

Inpatient stay

Follow-up

Participants are monitored for quality of life and recovery using questionnaires at 1 month, 3 months, 6 months, and 12 months

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Conventional CABG
• MICS CABG

Trial Overview

The MIST Trial compares two types of heart bypass surgeries: MICS CABG (through a small chest incision) and conventional sternotomy CABG (through a larger chest opening). It aims to assess which method offers better quality of life and quicker recovery post-surgery using patient questionnaires over one year.

How Is the Trial Designed?

Group I: Minimally-invasive CABG Experimental Treatment 1 Intervention

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

Group II: CABG with sternotomy Active Control 1 Intervention

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).

Conventional CABG is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Conventional CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease

Approved in United States as Traditional CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease
• Emergency CABG

Approved in Canada as Sternal CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease

Approved in Japan as Open-Heart CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease

Approved in China as Conventional CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease

Approved in Switzerland as Traditional CABG for:

• Multi-vessel coronary artery disease
• Single-vessel coronary artery disease

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Fresno Heart and Surgical Hospital

Collaborator

Trials

1

Recruited

180+

Far Eastern Memorial Hospital

Collaborator

Trials

269

Recruited

1,256,000+

Ichinomiya-Nishi Hospital

Collaborator

Trials

2

Recruited

2,700+

Jilin Heart Hospital

Collaborator

Trials

1

Recruited

180+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Gundersen Lutheran Health System

Collaborator

Trials

9

Recruited

2,500+

Apollo Hospitals Enterprise Limited

Collaborator

Trials

3

Recruited

300,000+

Fortis Escorts Heart Institute

Collaborator

Trials

2

Recruited

2,000+

Published Research Related to This Trial

A meta-analysis of nine randomized studies involving 1090 patients suggested that off-pump coronary artery bypass (OPCAB) may reduce the risk of serious complications like death, stroke, or heart attack compared to traditional on-pump CABG, although the results were not statistically significant.

The findings indicate a potential clinical benefit of OPCAB due to the avoidance of extracorporeal circulation, but more extensive randomized trials are necessary to confirm these advantages in early patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-pump versus on-pump coronary artery bypass: meta-analysis of currently available randomized trials. Parolari, A., Alamanni, F., Cannata, A., et al.[2019]

A study of 141 patients who underwent minimally invasive direct coronary artery bypass (MIDCAB) over 20 years showed excellent long-term survival rates, with 70% of patients alive at 20 years and a high freedom from major adverse cardiocerebral-related events (MACCE) at 61%.

MIDCAB resulted in shorter hospital stays and lower rates of blood transfusions and cardiac-related events compared to traditional full sternotomy bypass surgery, indicating it is a safer and more effective option for coronary revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Long-term Outcome of Minimally Invasive Direct Coronary Artery Bypass. Mastroiacovo, G., Manganiello, S., Pirola, S., et al.[2022]

Coronary artery bypass grafting without cardiopulmonary bypass, specifically through MIDCAB and OPCAB methods, shows potential for cost savings and reduced operating room time compared to conventional on-pump techniques, with average hospital costs of $15,000 for OPCAB and $17,000 for MIDCAB versus $19,000 for CCAB.

While MIDCAB and OPCAB patients had higher predicted risks for complications, the observed operative mortality rates were comparable, suggesting that off-pump procedures can be safely performed with similar outcomes to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of minimally invasive coronary artery bypass surgery. Arom, KV., Emery, RW., Flavin, TF., et al.[2019]

In a study of 38 patients who underwent minimally invasive direct coronary artery bypass (MIDCAB) from 2014 to 2016, there were no postoperative deaths and only one case of myocardial infarction, indicating a high safety profile for the procedure.

The study reported a 100% survival rate and freedom from major adverse cardiovascular and cerebrovascular events (MACCE) during a median follow-up of 17.3 months, demonstrating excellent long-term outcomes for low-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive direct coronary artery bypass (MIDCAB) – safety assessment in own material. Piątek, J., Konstanty-Kalandyk, J., Kędziora, A., et al.[2018]

In a study of 160 patients undergoing minimally invasive coronary artery bypass grafting, TECAB showed a higher rate of early bypass failure and reintervention compared to MIDCAB and PA-CABG, indicating potential challenges with this technique.

MIDCAB emerged as the most reliable method for isolated LAD grafting, with better long-term outcomes in terms of angina-free and reintervention-free survival, while all techniques were deemed safe overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there an optimal minimally invasive technique for left anterior descending coronary artery bypass? Jegaden, O., Wautot, F., Sassard, T., et al.[2021]

In a study of 126 patients undergoing coronary artery bypass grafting (CABG), minimally invasive direct coronary artery bypass (MIDCAB) showed similar clinical benefits to off-pump CABG but resulted in significantly less surgical bleeding and shorter hospital stays.

The MIDCAB group also had lower rates of death and cardiac shock at follow-up, indicating a better overall clinical prognosis compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect and Prognosis of Off-Pump Minimally Invasive Direct Coronary Artery Bypass. Yang, M., Xiao, LB., Gao, ZS., et al.[2019]

In a study comparing totally endoscopic coronary artery bypass (TECAB) and minimally invasive direct coronary artery bypass (MIDCAB) in 264 patients, both techniques showed no significant differences in perioperative complications such as myocardial infarction and stroke, indicating their safety.

TECAB had longer operative times compared to MIDCAB (292 minutes vs. 201 minutes), but both techniques had similar mid-term survival rates and freedom from major adverse cardiac events, suggesting that both methods are effective for coronary artery revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Perioperative and Mid-Term Results of TECAB and MIDCAB for Revascularization of Anterior Wall. Kofler, M., Schachner, T., Reinstadler, SJ., et al.[2018]

In a study of 23 high-risk patients undergoing off-pump coronary artery bypass surgery (OPCABG), the use of an intra-aortic balloon pump (IABP) preoperatively was associated with a significant increase in its application (70% vs 46% in on-pump patients), and no conversions to cardiopulmonary bypass were needed, indicating a safer approach for high-risk patients.

The OPCABG group showed a 97.5% patency rate of anastomosis and lower mortality rates compared to on-pump patients, along with trends toward reduced morbidity, suggesting that preoperative IABP may enhance the safety and efficacy of surgery in patients with critical left main stenosis or severe ventricular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-operative balloon counterpulsation and off-pump coronary surgery for high-risk patients. Babatasi, G., Massetti, M., Bruno, PG., et al.[2019]

In a study comparing 63 patients undergoing off-pump coronary artery bypass (OPCAB) and 63 patients undergoing on-pump coronary artery bypass (CCAB), OPCAB showed a 0% in-hospital mortality rate and no cases of perioperative myocardial infarction, while CCAB had a 3.2% mortality rate and 3.2% incidence of myocardial infarction.

OPCAB resulted in significantly fewer major postoperative complications (4 complications) compared to CCAB (13 complications), while maintaining a similar early graft patency rate (94.0% for OPCAB vs. 92.8% for CCAB), suggesting that OPCAB is a safer and less invasive option without compromising the quality of the bypass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results of off-pump coronary artery bypass: retrospective consecutive comparative study. Imamaki, M., Ishida, A., Shimura, H., et al.[2022]

Off-pump coronary artery bypass grafting (OPCAB) shows midterm clinical outcomes comparable to conventional on-pump CABG, with similar survival rates (98.3% for OPCAB vs. 98.2% for on-pump CABG) over a 3-year follow-up period.

Patients who achieved complete revascularization had significantly better cardiac event-free rates (96.7% for OPCAB and 92.7% for on-pump CABG) compared to those with incomplete revascularization, highlighting the importance of complete revascularization in reducing cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of off-pump and on-pump coronary artery bypass grafting in midterm results. Ishida, M., Kobayashi, J., Tagusari, O., et al.[2022]

In a study comparing 31 MIDCAB and 39 OPCAB procedures, OPCAB patients had significantly more grafts implanted and shorter coronary occlusion times, indicating greater surgical efficiency.

While MIDCAB patients experienced immediate extubation and some cosmetic benefits, they had higher complication rates and more residual discomfort after 3 months compared to OPCAB patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beating heart coronary artery surgery: is sternotomy a suitable alternative to minimal invasive technique? Gersbach, P., Imsand, C., von Segesser, LK., et al.[2019]

In a study of 1468 CABG patients, MICS-CABG showed a slightly shorter time to repeat revascularization (84.1 months) compared to traditional CABG (88.5 months), although the difference was not clinically significant.

MICS-CABG is associated with fewer complications and better postoperative recovery, suggesting it is a safe and effective alternative to traditional CABG despite the technical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeat Revascularization Post Coronary Artery Bypass Grafting: Comparing Minimally Invasive and Traditional Sternotomy Techniques in 1468 Cases. Olson, P., Cinelli, M., Rahming, HS., et al.[2022]

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