Heart Surgery for Coronary Artery Disease

Recruiting at 35 trial locations

Overseen By Dominic Emerson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Guideline-directed medical therapy

Disqualifiers: Decompensated HF, Recent MI, Severe valvular disease, Prior PCI, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF). The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization. The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that guideline-directed medical therapy should be started and adjusted to the highest tolerable doses, so you may need to continue or adjust your current medications.

What data supports the effectiveness of the treatment for coronary artery disease?

Research suggests that coronary artery bypass grafting (CABG) is often recommended over percutaneous coronary intervention (PCI) for patients with severe heart conditions, like multivessel disease and severe left ventricular dysfunction, due to better long-term outcomes. ^{1 2 3 4 5}

Is heart surgery for coronary artery disease generally safe?

Research shows that coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) can have complications, but they are widely used and studied procedures. Studies have analyzed adverse events and mortality rates, indicating that while there are risks, these procedures are generally considered safe for treating coronary artery disease. ^{6 7 8 9 10}

How is the treatment of coronary artery disease with CABG and PCI different from other treatments?

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are unique treatments for coronary artery disease because they physically restore blood flow to the heart by either bypassing blocked arteries (CABG) or opening them with a stent (PCI), unlike medications that manage symptoms or risk factors. CABG is often recommended for patients with more complex or severe artery blockages, while PCI is less invasive and may be preferred for less severe cases. ^{3 11 12 13 14}

Research Team

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Center, Toronto, Canada

Mario Gaudino, MD,PhD

Principal Investigator

Weill Medical College of Cornell University, USA

Jean L Rouleau, MD,PhD

Principal Investigator

Montreal Heart Institute, QC Canada

Guillaume Maquis-Gravel, MD,MSc

Principal Investigator

Montreal Heart Institute, QC Canada

Eligibility Criteria

This trial is for adults over 18 with ischemic cardiomyopathy, specifically those with significant blockages in multiple heart arteries and reduced heart pump function. Participants must have been on guideline-directed medical therapy for at least a month and be deemed suitable for non-emergency artery-opening procedures by their Heart Team.

Inclusion Criteria

I have severe blockage in multiple heart arteries.

I am older than 18 years.

My heart team agrees I've been on heart medication for at least a month.

Exclusion Criteria

I am not planning any major surgeries except for LAAO or AF ablation.

I have not had a heart stent procedure in the last year.

I cannot take certain blood thinners due to a high risk of bleeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Revascularization

Participants are randomized to either PCI or CABG, with initial revascularization expected within 2 weeks of randomization

2 weeks

Staged PCI

Staged PCI procedures are expected to take place within 90 days of randomization

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a median follow-up of 5 years

5 years

Treatment Details

Interventions

• Revascularization by CABG (Procedure)
• Revascularization by PCI (Procedure)

Trial Overview The STICH3C trial compares two types of artery-opening procedures: PCI (using catheters to place stents) versus CABG (open-heart surgery to bypass blocked vessels), in patients with weak heart muscles due to blocked arteries. The goal is to see which method better reduces the risk of death, stroke, repeat procedures, or hospital readmission over five years.

Participant Groups

Group I: Revascularization by PCI Experimental Treatment 1 Intervention

Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.

Group II: Revascularization by CABG Experimental Treatment 1 Intervention

Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon

Revascularization by CABG is already approved in Canada for the following indications:

Approved in Canada as CABG for:

• Ischemic cardiomyopathy
• Multivessel coronary artery disease
• Left main coronary artery disease
• Reduced left ventricular ejection fraction

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

In a review of 23 randomized controlled trials involving over 10,000 patients, coronary artery bypass graft (CABG) surgery was found to be more effective than percutaneous coronary intervention (PCI) in relieving angina and resulted in fewer repeated revascularization procedures, although it had a higher risk of procedural strokes (1.2% for CABG vs. 0.6% for PCI).

Survival rates after 10 years were similar for both CABG and PCI, with less than a 1% difference, indicating that while CABG may provide better symptom relief, both procedures offer comparable long-term survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. Bravata, DM., Gienger, AL., McDonald, KM., et al.[2022]

In a study of 1487 patients with coronary artery disease and moderate left ventricular dysfunction, percutaneous coronary intervention (PCI) was associated with a significantly lower 30-day mortality rate compared to coronary artery bypass grafting (CABG).

Over a mean follow-up of 4.5 years, both PCI and CABG showed similar long-term survival and heart failure hospitalization rates, but PCI had a higher risk of needing repeat revascularization, indicating a trade-off between short-term benefits and long-term intervention needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Patients with Coronary Artery Diseases and Moderate Left Ventricular Dysfunction: Percutaneous Coronary Intervention versus Coronary Artery Bypass Graft Surgery. Wang, S., Lyu, Y., Cheng, S., et al.[2022]

In a study of 4616 patients with multivessel disease and severe left ventricular systolic dysfunction, PCI with everolimus-eluting stents showed similar long-term survival rates compared to CABG, indicating its efficacy as a treatment option.

While PCI had a lower risk of stroke in the short term, it was associated with a higher risk of myocardial infarction and repeat revascularization in the long term, especially in cases of incomplete revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revascularization in Patients With Multivessel Coronary Artery Disease and Severe Left Ventricular Systolic Dysfunction: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery. Bangalore, S., Guo, Y., Samadashvili, Z., et al.[2022]

In a study of 116 patients with severe left ventricular dysfunction and coronary artery disease, coronary artery bypass surgery (CABG) resulted in significantly lower heart failure hospitalization rates compared to percutaneous coronary intervention (PCI) over a 3-year follow-up (16.2% vs. 42.2%).

While CABG showed better outcomes in terms of heart failure admissions, there was no significant difference in outcomes when compared to patients who underwent complete revascularization, indicating that extensive revascularization, regardless of method, is beneficial for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Complete Revascularization in Symptomatic Severe Left Ventricular Dysfunction between Coronary Artery Bypass Graft and Percutaneous Coronary Intervention. Fang, HY., Fang, YN., Chen, YC., et al.[2023]

In a study of 2509 patients with heart failure due to ischaemic heart disease, those who underwent coronary artery bypass grafting (CABG) had a significantly lower risk of death compared to those who received percutaneous coronary intervention (PCI), with an odds ratio of 0.62.

The analysis indicated that long-term survival was better after CABG, especially in hospitals where PCI was the preferred method, suggesting that CABG may be a more effective treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention: insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Völz, S., Redfors, B., Angerås, O., et al.[2021]

In the EXCEL trial involving 1,858 patients, nonfatal major adverse events (MAE) occurred significantly more often after coronary artery bypass grafting (CABG) (45.4%) compared to percutaneous coronary intervention (PCI) (11.9%), indicating a higher risk associated with CABG.

Experiencing a nonfatal MAE was a strong predictor of 5-year mortality for both PCI (4.61 times more likely) and CABG (3.25 times more likely), highlighting the importance of monitoring and managing these events post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Periprocedural Adverse Events After PCI and CABG on 5-Year Mortality: The EXCEL Trial. Jain, SS., Li, D., Dressler, O., et al.[2023]

After the introduction of public reporting and drug-eluting stents in 2003, in-hospital mortality and 1-year mortality rates for coronary artery bypass grafting (CABG) decreased, while mortality rates after percutaneous coronary intervention (PCI) remained unchanged.

Overall, the volume of coronary interventions in California decreased significantly, but the rates of adverse cardiovascular and cerebral events also declined, leading to an estimated reduction of over 6,000 adverse events annually by the end of the decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after coronary revascularization procedures in California 2000 to 2010. Rudersdorf, PD., Abolhoda, A., Carey, JS., et al.[2013]

In a study of 413 patients who had undergone prior coronary revascularization (either PCI or CABG), there was no significant difference in the risk of all-cause death, myocardial infarction, or stroke within one year after noncardiac surgery, indicating similar safety profiles for both procedures.

The analysis included a follow-up period of one year and showed that both PCI and CABG patients had comparable clinical outcomes, suggesting that prior revascularization type does not impact postoperative risks in noncardiac surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcome of Noncardiac Surgery in Patients With History of Coronary Artery Revascularization by Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graft Surgery. Park, J., Lee, SH., Kim, J., et al.[2022]

In a study of 40 high-risk patients undergoing coronary artery bypass grafting (CABG), those who received nurse-initiated preoperative education and counseling experienced significantly fewer postoperative complications compared to those who did not (P < .05).

The same group also reported lower anxiety levels after surgery, with mean anxiety scores significantly reduced (40.1 vs 48.9, P = .01), indicating that preoperative education can improve both clinical outcomes and patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of nurse-initiated preoperative education on postoperative anxiety symptoms and complications after coronary artery bypass grafting. Zhang, CY., Jiang, Y., Yin, QY., et al.[2022]

In a meta-analysis of over 2,000 patients, both minimally invasive direct coronary artery bypass graft surgery (MIDCABG) and percutaneous coronary intervention (PCI) showed comparable midterm mortality rates, indicating similar safety profiles for both procedures.

However, MIDCABG resulted in significantly lower rates of angina recurrence and the need for target vessel reinterventions compared to PCI, even when using drug-eluting stents, suggesting that MIDCABG may offer better long-term efficacy for patients with proximal LAD disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive direct coronary artery bypass graft surgery or percutaneous coronary intervention for proximal left anterior descending artery stenosis: a meta-analysis. Deo, SV., Sharma, V., Shah, IK., et al.[2018]

In a study of 430 patients with severe coronary artery disease, both coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) showed no significant difference in the prevalence of major adverse cardiovascular and cerebrovascular events (MACCE) after five years.

The Global Risk Classification (GRC) scoring system effectively predicted MACCE with an area under the curve (AUC) of 0.701, highlighting its utility in assessing long-term risks in patients post-revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up on two revascularization methods used on patients with left main artery disease and/or multivessel coronary artery disease. Xu, YJ., Yang, PJ., Chen, ZQ., et al.[2023]

In a study of 658 patients who underwent coronary artery bypass grafting (CABG), the 30-day complication rate was 16%, with a low mortality rate of 2%, indicating that CABG is a relatively safe procedure for patients with coronary artery disease.

Long-term survival rates were high, with 97.4% of patients surviving at 1 year, 93.8% at 3 years, and 90.9% at 5 years, suggesting that CABG is effective in improving outcomes for patients with stable angina and preserved heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early and late results of coronary artery bypass grafting in coronary artery disease in Concepcion, Chile]. González L, R., Reyes M, R., Stockins L, A., et al.[2019]

In a study of four patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting (CABG), the use of a microaxial temporary mechanical circulatory support (tMCS) device (Impella 5.0®) successfully prevented postoperative low-output states without any device-related complications.

While all patients survived to device explant, there was a notable incidence of acute renal failure (50%), particularly in those with preoperative cardiogenic shock, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary mechanical circulatory support prevents the occurrence of a low-output state in high-risk coronary artery bypass grafting: A case series. Smith, NJ., Ramamurthi, A., Joyce, LD., et al.[2021]

Revascularization methods like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are more effective than just medical management for alleviating symptoms and increasing exercise duration in patients with coronary artery disease (CAD).

A review of ten randomized trials indicates that both PCI and CABG provide significant benefits for patients with multivessel CAD, suggesting that these revascularization strategies should be prioritized over medical management alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous coronary intervention versus coronary artery bypass grafting: clinical outcomes in multivessel coronary artery disease. Ledford, CS., Grines, CL.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Patients with Coronary Artery Diseases and Moderate Left Ventricular Dysfunction: Percutaneous Coronary Intervention versus Coronary Artery Bypass Graft Surgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Revascularization in Patients With Multivessel Coronary Artery Disease and Severe Left Ventricular Systolic Dysfunction: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Impact of Complete Revascularization in Symptomatic Severe Left Ventricular Dysfunction between Coronary Artery Bypass Graft and Percutaneous Coronary Intervention. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention: insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Periprocedural Adverse Events After PCI and CABG on 5-Year Mortality: The EXCEL Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events after coronary revascularization procedures in California 2000 to 2010. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcome of Noncardiac Surgery in Patients With History of Coronary Artery Revascularization by Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graft Surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of nurse-initiated preoperative education on postoperative anxiety symptoms and complications after coronary artery bypass grafting. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Minimally invasive direct coronary artery bypass graft surgery or percutaneous coronary intervention for proximal left anterior descending artery stenosis: a meta-analysis. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Five-year follow-up on two revascularization methods used on patients with left main artery disease and/or multivessel coronary artery disease. [2023]

12. Chile pubmed.ncbi.nlm.nih.gov

[Early and late results of coronary artery bypass grafting in coronary artery disease in Concepcion, Chile]. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Temporary mechanical circulatory support prevents the occurrence of a low-output state in high-risk coronary artery bypass grafting: A case series. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Percutaneous coronary intervention versus coronary artery bypass grafting: clinical outcomes in multivessel coronary artery disease. [2019]