Single vs Multiple Arterial Grafts for Heart Disease

(ROMA:Women Trial)

Recruiting in Columbus (<10 mi)

+142 other locations

Overseen By Molly Schultheis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Male, Single graft, Emergency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate postoperative period

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

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.

Is it safe to use multiple arterial grafts (MAG) compared to single arterial grafts (SAG) in heart surgery?

Research shows that using multiple arterial grafts (MAG) in heart surgery is associated with better survival rates and fewer major heart and brain events compared to single arterial grafts (SAG). This suggests that MAG is generally safe and may offer additional benefits over SAG. ^{1 2 3 4 5}

How does the treatment of multiple arterial grafting differ from single arterial grafting for heart disease?

Multiple arterial grafting (MAG) involves using more than one artery to bypass blocked heart vessels, which may lead to better outcomes in terms of revascularization (restoring blood flow) and reduced risk of stroke compared to single arterial grafting (SAG). However, MAG may also have a higher risk of sternal wound complications. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Multiple Arterial Grafting (MAG) for heart disease?

Research shows that using multiple arterial grafts (MAG) in heart bypass surgery is linked to better survival rates and fewer major heart and brain-related problems compared to using a single arterial graft (SAG). This benefit is observed in both men and women, and is particularly noted in patients with multivessel coronary artery disease. ^{1 2 3 7 8}

Who Is on the Research Team?

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Mario Gaudino, Prof/PhD/MD

Principal Investigator

Weill Medical College of Cornell University

Karla Ballman, PhD

Principal Investigator

Weill Medical College of Cornell University

Sean O'Brien, PhD

Principal Investigator

Duke University

Ruth Masterson Creber, RN, PhD

Principal Investigator

Columbia University

C. Noel Bairey Merz, MD

Principal Investigator

Cedars-Sinai

Are You a Good Fit for This Trial?

This trial is for women over 18 facing their first heart surgery due to significant coronary artery disease. They must not have had previous cardiac surgeries, recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy.

Inclusion Criteria

I am a woman aged 18 or older.

I have had surgery to improve blood flow to my heart.

I have severe heart artery disease affecting the main or left arteries.

Exclusion Criteria

I have had heart surgery in the past.

I am male.

I do not have severe organ problems or other health issues that could shorten my life to under 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo coronary artery bypass grafting (CABG) with either single or multiple arterial grafts

Immediate postoperative period

In-hospital stay for surgery and recovery

Follow-up

Participants are monitored for major adverse cardiac and cerebrovascular events and quality of life outcomes

Minimum 2.5 years

Regular follow-up visits as per protocol

Long-term follow-up

Extended monitoring for long-term outcomes and safety endpoints

Beyond 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Multiple arterial grafting
• Single arterial graft

Trial Overview The study compares the effectiveness of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing bypass surgery. It aims to see if MAG can better prevent major heart and brain events and improve quality of life.

How Is the Trial Designed?

Group I: Single Arterial Graft (SAG) group Experimental Treatment 1 Intervention

Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.

Group II: Multiple Arterial Graft (MAG) group Experimental Treatment 1 Intervention

Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.

Multiple arterial grafting is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Multiple Arterial Grafting for:

• Coronary artery bypass grafting (CABG)

Approved in European Union as Multiple Arterial Grafting for:

• Coronary artery bypass grafting (CABG)

Approved in Canada as Multiple Arterial Grafting for:

• Coronary artery bypass grafting (CABG)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Maastricht University Medical Center

Lead Sponsor

Trials

992

Recruited

3,304,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Oxford University Hospitals NHS Trust

Collaborator

Trials

224

Recruited

1,703,000+

New York Presbyterian Hospital

Collaborator

Trials

77

Recruited

57,300+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of Göttingen

Collaborator

Trials

69

Recruited

43,500+

Published Research Related to This Trial

In a study of 2,446 matched pairs of women undergoing coronary artery bypass grafting (CABG), multiple arterial grafting (MAG) was associated with greater long-term survival and reduced major adverse cardiac and cerebrovascular events (MACCE) compared to single arterial grafting (SAG).

After a median follow-up of 5 years, MAG showed a significant survival benefit (HR 0.85) and lower risk of MACCE (HR 0.85), suggesting that MAG is a beneficial option for women with multivessel disease undergoing CABG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple arterial coronary bypass grafting is associated with greater survival in women. Tam, DY., Rocha, RV., Fang, J., et al.[2023]

In a study of 336,321 patients undergoing isolated coronary artery bypass grafting (CABG) in the UK from 1996 to 2018, the use of multiple arterial grafting (MAG) initially increased but then steadily declined, particularly the use of the radial artery.

Patients receiving single arterial grafting had lower in-hospital mortality rates and fewer complications, such as the need for return to surgery for bleeding, suggesting that while MAG has benefits, single arterial grafting may be safer in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trend and factors associated with multiple arterial revascularization in coronary artery bypass grafting in the UK. Chan, J., Dimagli, A., Dong, T., et al.[2022]

In a study of over 50,000 patients undergoing coronary artery bypass grafting (CABG), using 3 arterial grafts did not lead to better long-term outcomes compared to using 2 arterial grafts, with no significant differences in in-hospital death or major adverse events over an 8-year follow-up.

However, patients receiving multiple arterial grafts (MAG) showed significantly better long-term outcomes compared to those with a single arterial graft (SAG), including lower rates of major adverse cardiac events, improved survival, and reduced need for repeat revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Arterial Grafting Is Associated With Better Outcomes for Coronary Artery Bypass Grafting Patients. Rocha, RV., Tam, DY., Karkhanis, R., et al.[2019]

In a study of 63,402 patients undergoing coronary artery bypass graft surgery, those receiving multiple arterial grafts (MAGs) showed lower mortality rates at 7 years compared to those receiving single arterial grafts (SAGs), with a significant adjusted hazard ratio of 0.86.

While there was no difference in mortality between MAG and SAG patients at 1 year, MAG patients had better long-term outcomes, including lower rates of repeat revascularization and a composite outcome of mortality, myocardial infarction, and stroke after 7 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Versus Single Arterial Coronary Bypass Graft Surgery for Multivessel Disease. Samadashvili, Z., Sundt, TM., Wechsler, A., et al.[2020]

In a study of 5738 patients with multivessel coronary artery disease and atrial fibrillation undergoing CABG, multiple arterial grafting (MAG) was associated with a 20% improvement in mid-term survival compared to single arterial grafting (SAG).

The safety of MAG was confirmed, with no significant difference in in-hospital outcomes or 1-year mortality risk, making it a viable option, especially for lower-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Versus Single Arterial Coronary Arterial Bypass Grafting Surgery for Multivessel Disease in Atrial Fibrillation. Kowalewski, M., Pasierski, M., Litwinowicz, R., et al.[2022]

A meta-analysis of 44 studies involving 180 to 459 patients found that multiple arterial grafting (MAG) significantly improves overall survival and event-free survival compared to single arterial grafting (SAG) in coronary artery bypass grafting (CABG).

The study also revealed that using the right internal mammary artery (RIMA) as a second conduit leads to better survival outcomes than the radial artery (RA), particularly benefiting older patients, females, and those with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in long-term survival outcomes after coronary artery bypass grafting using single vs multiple arterial grafts: a meta-analysis with reconstructed time-to-event data and subgroup analyses. Magouliotis, DE., Fergadi, MP., Zotos, PA., et al.[2023]

In a study of 1743 patients with coronary artery disease followed for a median of 11.9 years, multiple arterial grafting (MAG) was associated with significantly lower all-cause mortality compared to percutaneous coronary intervention (PCI), suggesting MAG may be a better option for long-term survival.

For patients with three-vessel disease, both MAG and single arterial grafting (SAG) showed lower mortality rates than PCI, while no significant differences were found in patients with left main coronary artery disease, indicating the effectiveness of arterial grafting may vary based on the type of coronary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. Davierwala, PM., Gao, C., Thuijs, DJFM., et al.[2022]

In a meta-analysis of 10 randomized controlled trials involving 6392 patients, multiple arterial graft (MAG) coronary artery bypass surgery showed no significant survival advantage over single arterial grafts (SAG) for all-cause mortality, cardiac mortality, or myocardial infarction, indicating similar safety profiles.

MAG was associated with a lower risk of repeat revascularization and stroke compared to SAG, but it also had a higher incidence of sternal wound complications, suggesting that while MAG may offer some benefits, these must be weighed against the increased risk of surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis Comparing Multiple Arterial Grafts Versus Single Arterial Graft for Coronary-Artery Bypass Grafting. Changal, K., Masroor, S., Elzanaty, A., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Multiple arterial coronary bypass grafting is associated with greater survival in women. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Trend and factors associated with multiple arterial revascularization in coronary artery bypass grafting in the UK. [2022]

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

Multiple Arterial Grafting Is Associated With Better Outcomes for Coronary Artery Bypass Grafting Patients. [2019]

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

Multiple Versus Single Arterial Coronary Bypass Graft Surgery for Multivessel Disease. [2020]

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

Multiple Versus Single Arterial Coronary Arterial Bypass Grafting Surgery for Multivessel Disease in Atrial Fibrillation. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Differences in long-term survival outcomes after coronary artery bypass grafting using single vs multiple arterial grafts: a meta-analysis with reconstructed time-to-event data and subgroup analyses. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. [2022]

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

Meta-Analysis Comparing Multiple Arterial Grafts Versus Single Arterial Graft for Coronary-Artery Bypass Grafting. [2020]