Single vs Multiple Arterial Grafts for Heart Disease

(ROMA:Women Trial)

Recruiting at 156 trial 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?

This trial explores whether using multiple arterial grafts (MAG) instead of a single arterial graft (SAG) during coronary artery bypass surgery can enhance heart health and quality of life for women. The aim is to reduce serious heart and brain issues, such as heart attacks or strokes, and to improve overall well-being. Women undergoing their first heart surgery for blocked arteries may be suitable candidates, particularly if they have significant blockages in specific heart arteries. The study compares two groups: one receiving a single arterial graft and the other receiving multiple arterial grafts. As an unphased trial, this study provides a unique opportunity for women to contribute to groundbreaking research that could improve surgical outcomes and quality of life.

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

Research has shown that using more than one artery for heart surgery, known as multiple arterial grafting (MAG), offers promising safety and effectiveness. Studies have found that MAG is linked to lower death rates over time and fewer repeat surgeries compared to single arterial grafting (SAG). This means people with MAG often live longer without needing another surgery, and these benefits do not increase the risks related to the surgery itself.

Conversely, SAG is also safe, particularly for older patients. Studies have shown that SAG does not lead to more immediate health risks after surgery. However, compared to MAG, SAG might not provide the same long-term benefits.

In summary, both MAG and SAG are safe options for heart surgery. MAG may offer better long-term benefits without adding extra risk during the surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the use of single versus multiple arterial grafts for heart disease because these approaches could improve outcomes for patients undergoing coronary artery bypass surgery. Traditionally, treatments involve mainly venous grafts, but arterial grafts are believed to last longer and perform better over time. The multiple arterial grafting technique is particularly promising as it utilizes more durable arteries like the radial or right internal thoracic artery, which may improve long-term blood flow and reduce the chances of needing future surgeries. By comparing these two techniques, researchers hope to determine if more arterial grafts can significantly enhance patient longevity and quality of life compared to current standards.

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

This trial will compare the effectiveness of Single Arterial Grafting (SAG) with Multiple Arterial Grafting (MAG) for heart disease. Research has shown that using more than one artery in heart surgery, known as MAG, can lead to better results. Studies have found that patients with MAG have a lower risk of dying, are less likely to experience another heart attack, and require fewer repeat surgeries compared to those with SAG. Specifically, MAG is linked to better survival rates and fewer major heart problems over time. Across different patient groups, whether they have stable heart disease or sudden issues, MAG consistently leads to better outcomes. Overall, MAG is considered more effective than SAG for improving results in heart surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Sean O'Brien, PhD

Principal Investigator

Duke University

Mario Gaudino, Prof/PhD/MD

Principal Investigator

Weill Medical College of Cornell University

Ruth Masterson Creber, RN, PhD

Principal Investigator

Columbia University

C. Noel Bairey Merz, MD

Principal Investigator

Cedars-Sinai

Karla Ballman, PhD

Principal Investigator

Weill Medical College of Cornell University

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 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]

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]

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 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 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]

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]

Citations

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Multiple Arterial Grafting Is Associated With Better ... Observational studies have shown better survival in patients undergoing coronary artery bypass grafting (CABG) with 2 arterial grafts ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5710366/

Long-term Outcomes of Multiple Arterial Coronary ... Multiple arterial grafting was associated with significant reductions in long-term mortality and repeated revascularization without increased perioperative ...

3. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(24)00063-8/fulltext

Multiarterial vs Single-Arterial Coronary Surgery: 10-Year ... The multiarterial treatment benefit was comparable in cases of urgent and elective surgery, whereas it was less pronounced in cases of off-pump ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424003378

Superior Outcomes of Dual-Arterial Coronary ... DAG was associated with improved long-term MACCE outcomes compared to SAG. These results suggest that the practice of DAG in the VA benefits Veterans.

5. mdpi.com mdpi.com/2813-2475/4/3/29

Multiple Arterial Grafting in CABG: Outcomes, Concerns, ... After rigorous risk adjustment, MAG was associated with a significant survival advantage at 10 years, with improved hazard ratios across subgroups, including ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914925005727

Single Arterial versus Multiple Arterial Grafting in ... Diabetic patients undergoing coronary artery bypass grafting (CABG) are at increased risk of adverse outcomes, yet the role of multiple ...

7. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1555242/full

Comparison of multiple arterial grafts vs. single ... The MAG group demonstrated a lower risk of all-cause mortality, cardiac mortality, MI, and repeat revascularization compared with the SAG group.