Single vs Multiple Arterial Grafts for Heart Disease

(ROMA:Women Trial)

Recruiting in Palo Alto (17 mi)

+123 other locations

Overseen by Stephen Fremes, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Male, Single graft, Emergency, others

No Placebo Group

Trial Summary

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.

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 4 5}

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 4 6 7}

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. ^{1 4 5 6 8}

Research Team

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

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

Sean O'Brien, PhD

Principal Investigator

Duke University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Multiple arterial grafting (Procedure)
• Single arterial graft (Procedure)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Multiple Arterial Grafting for:

• Coronary artery bypass grafting (CABG)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Massachusetts Chan Medical School Worcester, MA

Methodist Physicians Health Omaha, NE

Englewood Health Englewood, NJ

Institut Universitaire de Cardiologie et de Pneumologie de Québec Ste Foy, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1103

Patients Recruited

1,157,000+

Maastricht University Medical Center

Lead Sponsor

Trials

992

Patients Recruited

3,304,000+

Duke University

Collaborator

Trials

2495

Patients Recruited

5,912,000+

Oxford University Hospitals NHS Trust

Collaborator

Trials

224

Patients Recruited

1,703,000+

New York Presbyterian Hospital

Collaborator

Trials

77

Patients Recruited

57,300+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Patients Recruited

1,569,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Patients Recruited

165,000+

Columbia University

Collaborator

Trials

1529

Patients Recruited

2,832,000+

University of Göttingen

Collaborator

Trials

69

Patients Recruited

43,500+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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]