Heart Surgery for Coronary Artery Disease

Recruiting at 44 trial locations

Overseen By Dominic Emerson

Age: 18+

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: Unknown

754 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to improve blood flow in individuals with coronary artery disease and weak heart function. It compares coronary artery bypass grafting (CABG), a type of heart surgery, with percutaneous coronary intervention (PCI), a procedure that uses small tubes (stents) to open arteries. The trial aims to determine which method results in fewer heart problems, such as heart attacks or heart failure, over five years. Individuals with heart artery blockages and reduced heart pumping ability might be suitable candidates for this trial. As an unphased trial, participants can contribute to significant research that may enhance treatment options for heart conditions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) have been thoroughly studied for safety. CABG is generally safe, with less than 2.1% of patients dying in the hospital. However, it carries high risk, as about 14% of patients may experience complications within 30 days after surgery. This indicates that some patients might encounter issues soon after the procedure.

Conversely, PCI has a higher rate of serious heart-related problems compared to CABG. Specifically, the chance of death from any cause is higher with PCI (14.6% for PCI versus 9.2% for CABG), as is the risk of heart attacks (9.2% for PCI versus 4.0% for CABG).

Both treatments present risks and benefits. It is crucial to discuss with doctors to determine which option might be safer personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for coronary artery disease because they aim to refine revascularization techniques using CABG (Coronary Artery Bypass Grafting) and PCI (Percutaneous Coronary Intervention). Unlike standard treatments, this trial focuses on a personalized approach by involving a specialized Heart Team to decide the best method for addressing significant blockages, considering vessel diameter and lesion location. This collaborative decision-making could lead to more effective and tailored interventions, potentially improving outcomes for patients with complex coronary artery disease.

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

This trial will compare two treatments for coronary artery disease: coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). Research has shown that both CABG and PCI can extend the lives of people with left main coronary artery disease compared to medication alone. Participants in this trial may receive CABG, which significantly reduces the risk of heart problems for those with multiple blocked arteries and weakened heart function. Alternatively, participants may receive PCI, which, especially with newer stents, effectively improves blood flow in the heart. Some studies suggest that PCI is becoming more common for patients with heart failure and coronary artery disease, and it is associated with better outcomes. Overall, both treatments have strong evidence supporting their benefits in improving heart health and survival. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Revascularization by CABG
• Revascularization by PCI

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as CABG for:

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

Approved in United States as CABG for:

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

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+

Published Research Related to This Trial

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]

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]

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 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 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 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]

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 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 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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4620070/

Cost-effectiveness modelling of percutaneous coronary ... The objective of this study is to develop a cost-effectiveness model comparing drug eluting stents (DES) vs bare metal stent (BMS) in patients suffering of ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026960

Procedural Outcomes After Percutaneous Coronary ... PCI in vessels with high PPG (focal CAD) resulted in higher post‐PCI FFR (0.91±0.07 in the focal group versus 0.86±0.05 in the diffuse group, P< ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130480/

Long-term outcomes of percutaneous coronary ... The primary endpoint of the study occurred in 59.7% of patients after the mean time of 669.6 ±598.7 days. The TVR occurred in 37.9% of individuals, TLR in 24.2% ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1909406

Five-Year Outcomes after PCI or CABG for Left Main ... Survival among patients with left main coronary artery disease is longer after revascularization with either PCI or CABG than with medical therapy alone. In six ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2021.03.310

Impact of Percutaneous Coronary Intervention on ... The use of percutaneous coronary intervention (PCI) in HF patients with CAD has markedly increased and has been suggested to be associated with improved ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591588/

Investigating outcomes of coronary artery bypass graft (CABG ... Still, CABG is a high-risk procedure with a 30-day morbidity rate of 14%. Almost 14% of Medicare post-CABG patients are readmitted within 30 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1994021/

Outcomes of coronary artery bypass graft surgery - PMC The overall 5-year cumulative survival rates in the medically assigned group (92%) and the surgically assigned group (95%) were similar. No significant ...

8. ccjm.org ccjm.org/content/92/3/181

Coronary artery bypass grafting: Practice trends and ... CABG is a safe procedure, with national in-hospital mortality below 2.1%, operative mortality below 2.7%, and centers of excellence maintaining ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.068312

Coronary Artery Bypass Grafting: Past and Future Worse risk-adjusted mortality after CABG has also been reported in Black patients and in patients from socioeconomically deprived communities.

10. opencardiovascularmedicinejournal.com opencardiovascularmedicinejournal.com/VOLUME/18/ELOCATOR/e18741924331868/FULLTEXT/

Long-term Outcomes of Coronary Artery Bypass Grafting ... This study aims to compare the efficacy and safety of surgical myocardial revascularization using CABG vs. staged HCR.