Medical vs Surgical Treatments for Heart Failure

(ISCHEMIA-LVD Trial)

Not yet recruiting at 6 trial locations

Overseen By S. Bangalore, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NYU Langone Health

Disqualifiers: Decompensated heart failure, Stroke, Dementia, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best treatment for individuals with heart failure and severe coronary artery disease. It compares three approaches: medication following medical guidelines, coronary artery bypass surgery, and percutaneous coronary intervention (PCI), a procedure that opens clogged heart arteries. The trial seeks participants with heart failure and reduced pumping ability (ejection fraction of 40% or less) and severe artery blockage treatable with surgery or intervention. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves medical therapy, it's possible that some adjustments might be needed. Please discuss this with the trial team for specific guidance.

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

Research has shown that coronary artery bypass grafting (CABG) is a well-researched treatment for heart issues like multivessel coronary artery disease. Studies indicate that CABG is generally safe and often improves survival rates and reduces heart problems over time.

For percutaneous coronary intervention (PCI), research suggests it is also generally safe in the long term, with a safety record similar to CABG. PCI is often compared to CABG and has demonstrated similar success in treating heart conditions.

Guideline-directed medical therapy (GDMT) uses medications to manage heart failure. Research indicates that GDMT is safe and can enhance heart function while lowering the risk of serious heart problems.

Overall, CABG, PCI, and GDMT are considered generally safe based on past research. Each has been extensively studied and shown to benefit heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for heart failure with reduced ejection fraction (HFrEF) because they offer distinct approaches compared to standard care. Coronary artery bypass grafting (CABG) directly improves blood flow to the heart by bypassing blocked arteries, potentially offering more durable relief for patients with multivessel coronary artery disease. Percutaneous coronary intervention (PCI) provides a less invasive option to open narrowed arteries using stents, which can be appealing for patients who may not be candidates for surgery. Meanwhile, guideline-directed medical therapy (GDMT) focuses on optimizing medication regimens tailored to individual patient needs, potentially offering a more personalized treatment approach. These varied strategies highlight the potential for more tailored heart failure management, which could lead to improved outcomes and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare different treatments for heart failure. Research has shown that coronary artery bypass grafting (CABG) can be very effective for patients with heart failure due to blocked arteries. A major study found that patients who underwent CABG lived longer. In this trial, some participants will receive CABG, while others will receive percutaneous coronary intervention (PCI). Some studies suggest PCI can improve heart function and quality of life, though it might not be as effective as CABG in all cases. Another group will receive guideline-directed medical therapy (GDMT), a combination of recommended medications proven to lower the risk of hospital visits and death in heart failure patients. Each treatment has its benefits, but the best choice often depends on the individual patient's situation. ^{2 3 6 7 8}

Who Is on the Research Team?

S. Bangalore, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people with multivessel coronary artery disease and a heart pumping strength (ejection fraction) of 40% or less. It's not specified who can't join, but typically those with other serious health issues or conditions that could interfere with the study might be excluded.

Inclusion Criteria

My heart condition can be treated with stenting or bypass surgery.

I am willing to follow all study requirements, including treatments and check-ups.

My heart's pumping ability is below 40% as shown in recent tests.

Exclusion Criteria

I have not had severe heart failure or shock in the last 2 days.

History of noncompliance with medical therapy

Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive guideline-directed medical therapy (GDMT), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI)

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive and health status assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Coronary artery bypass grafting (CABG)
• Guideline-directed medical therapy (GDMT)
• Percutaneous coronary intervention (PCI)

Trial Overview

The ISCHEMIA-HF trial is testing three approaches to treat heart problems caused by narrowed arteries: medical therapy alone, surgery to bypass blocked vessels (CABG), and a non-surgical procedure to open arteries (PCI). Participants are randomly assigned in specific ratios to each treatment group.

How Is the Trial Designed?

Group I: PCI Experimental Treatment 1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI.

Group II: GDMT Experimental Treatment 1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT.

Group III: CABG Experimental Treatment 1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG.

Coronary artery bypass grafting (CABG) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Approved in Canada as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Approved in European Union as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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]

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 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

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sciencedirect.com

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Ten-year outcomes of coronary artery bypass grafting ...

Surgical Treatment for Ischemic Heart Failure Extension Study (STITCHES) trial [14] compared those with ischemic cardiomyopathy to CABG or ...

2.

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pmc.ncbi.nlm.nih.gov/articles/PMC10183509/

Long-term outcomes after coronary artery bypass graft with ...

Prucz et al. demonstrated an excellent 4-year survival of 75% and 62% in CHF patients with ischemic cardiomyopathy who underwent CABG and SVR and I-CABG, ...

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Coronary artery bypass grafting: Practice trends and ...

In 2021, guidelines for CABG in patients with ischemic cardiomyopathy and heart failure were issued by the American Association for Thoracic ...

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Ten-Year Outcomes After Coronary Artery Bypass Grafting ...

Whether the efficacy of CABG compared with medical therapy (MED) in patients with heart failure caused by ischemic cardiomyopathy is the same in ...

5.

nature.com

nature.com/articles/s41598-023-49069-2

Comparing outcomes between coronary artery bypass ...

We performed a meta-analysis of studies comparing outcomes in octogenarians with left main or multivessel disease who underwent CABG or PCI.

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Clinical outcomes of multivessel coronary artery disease ...

The treatment goal of MVD revascularization is to reduce angina, and ischemic heart failure and to improve patient survival. Once the safety and ...

7.

jamanetwork.com

jamanetwork.com/journals/jamacardiology/fullarticle/2763557

Long-term Outcomes in Patients With Severely Reduced ...

... coronary artery bypass grafting in women and men with heart failure. ... bypass surgery for multivessel coronary disease according to ...

8.

nature.com

nature.com/articles/s41598-024-53905-4

Five-year outcomes in patients with multivessel coronary ...

The outcomes from real-life clinical studies regarding the optimal revascularization strategy in patients with multivessel coronary artery ...