Medical vs Surgical Treatments for Heart Failure

(ISCHEMIA-LVD Trial)

Recruiting at 5 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

1200 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Coronary artery bypass grafting (CABG) for heart failure?

Guidelines recommend coronary artery bypass graft surgery (CABG) over percutaneous coronary intervention (PCI) for patients with multivessel coronary artery disease and severe heart muscle weakness, suggesting CABG may be more effective in these cases. ^{1 2 3 4 5}

Is coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) generally safe for humans?

Research shows that both coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) have been studied for safety, with adverse events and mortality rates being monitored. While these procedures can be lifesaving, they do carry risks of adverse events, which have been analyzed over time to improve safety. ^{4 6 7 8 9}

How does coronary artery bypass grafting (CABG) differ from other treatments for heart failure?

Coronary artery bypass grafting (CABG) is a surgical treatment that involves creating a new path for blood to flow to the heart by bypassing blocked arteries, which is different from percutaneous coronary intervention (PCI) that uses stents to open blocked arteries without surgery. CABG is often recommended for patients with severe heart conditions involving multiple blocked arteries, as it may offer better long-term outcomes compared to PCI or medication alone. ^{1 2 3 10 11}

What is the purpose of this trial?

The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).

Research Team

S. Bangalore, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

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

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

Exclusion Criteria

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

I have dementia and cannot make medical decisions.

History of noncompliance with medical therapy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy. [2022]

2. 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]

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

It's not all about ISCHEMIA: the case for coronary artery bypass grafting in stable coronary artery disease. [2023]

4. North Macedonia pubmed.ncbi.nlm.nih.gov

Pharmacotherapy Evaluation and Utilization in Coronary Artery Bypass Grafting Patients in Kosovo during the Period 2016-2017. [2020]

5. 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]

6. India pubmed.ncbi.nlm.nih.gov

Do practice gaps exist in evidence-based medication prescription at hospital discharge in patients undergoing coronary artery bypass surgery & coronary angioplasty? [2022]

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

Management of heart failure. III. The role of revascularization in the treatment of patients with moderate or severe left ventricular systolic dysfunction. [2019]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Coronary artery bypass graft surgery: discharge planning for successful recovery. [2004]

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

The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. [2021]

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

Comparison of three treatment strategies for patients with triple-vessel coronary disease and left ventricular dysfunction. [2018]