Single vs Multiple Arterial Grafts for Heart Disease

(ROMA Trial)

Not currently recruiting at 62 trial locations

Overseen By Marshagay Rodriques

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Age > 70, Previous cardiac surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: In-hospital stay, up to 30 days post-operatively

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using two or more arterial grafts during heart bypass surgery is more effective than using just one. The researchers aim to determine if multiple grafts can reduce the risk of death, stroke, heart attacks after discharge, and the need for additional heart procedures. Suitable participants have heart disease affecting specific arteries and are scheduled for non-emergency bypass surgery. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance heart surgery outcomes.

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 prior data suggests that these grafting techniques are safe for heart disease patients?

Research has shown that using one or more arteries in heart bypass surgery is generally safe for patients. Studies have found that using multiple arteries is linked to a lower risk of long-term mortality. This suggests that patients are less likely to die over time after having multiple arteries used, even if they have conditions like diabetes or obesity.

Using one artery is also safe, but it may carry a slightly higher risk of complications such as heart attacks or the need for additional surgery compared to using multiple arteries.

In summary, both options are safe, but using multiple arteries might lead to better long-term outcomes for some patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of using multiple arterial grafts for treating heart disease because this approach could improve long-term outcomes compared to the standard method of using a single arterial graft combined with venous grafts. While the traditional single arterial graft method typically utilizes the left internal thoracic artery, the multiple arterial graft strategy incorporates additional arteries, like the right internal thoracic artery or the radial artery, which may enhance the durability and function of the grafts. By potentially reducing the risk of graft failure and improving blood flow to the heart, this technique offers a promising alternative that could lead to better patient outcomes and longevity.

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

Research has shown that using more than one artery for grafts during heart bypass surgery leads to better outcomes than using just one. In this trial, participants in the Multiple Arterial Group will receive multiple arterial grafts, while those in the Single Arterial Group will receive a single arterial graft. Studies have found that patients with multiple artery grafts have a lower risk of dying from any cause and are less likely to need another heart procedure later on. Specifically, one study showed that these patients lived longer over a 10-year period. Additionally, those with multiple grafts experienced fewer heart attacks and strokes after surgery. Overall, the evidence suggests that using multiple grafts more effectively improves long-term heart health. ^{1 2 5 6 7}

Who Is on the Research Team?

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Mario Gaudino, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for patients with coronary artery disease who need non-emergency heart bypass surgery and haven't had previous cardiac surgeries. It's not for those over 70, with recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy to under 5 years.

Inclusion Criteria

I have heart disease affecting specific arteries.

Exclusion Criteria

I cannot use my saphenous vein or both my radial and right internal thoracic arteries.

I am expected to need surgery to remove blockages from my heart's arteries.

I am undergoing or have undergone other heart or non-heart related surgeries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo coronary artery bypass surgery with either single or multiple arterial grafts

In-hospital stay, up to 30 days post-operatively

Hospital stay

Follow-up

Participants are monitored for major postoperative complications and composite outcomes

5 years

Regular follow-up visits

Long-term follow-up

Analysis of composite outcomes and cause-specific death

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Multiple Arterial Grafting
• Single Arterial Graft

Trial Overview The ROMA trial is testing if using multiple arterial grafts in heart bypass surgery is better than a single graft at reducing death, strokes, heart attacks, and the need for more surgery. Patients are randomly assigned to either group in equal numbers across international centers.

How Is the Trial Designed?

Group I: Single Arterial 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 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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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 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]

Citations

1. 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 ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.034464

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 ...

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. ccjm.org ccjm.org/content/92/3/181

Coronary artery bypass grafting: Practice trends and ... Multiarterial grafting can offer better long-term survival and lower risk of adverse cardiac events for patients undergoing CABG. Innovations ...

5. ajconline.org ajconline.org/article/S0002-9149(25)00572-7/abstract

Single Arterial Versus Multiple Arterial Grafting in ... Kaplan–Meier survival estimates showed comparable survival (p = 0.954) at 1 year (92% vs 91%), 5 years (85% vs 83%), 10 years (73% vs 73%), 15 years (57% vs 62 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29453002/

Operative Outcomes of Multiple-Arterial Versus Single- ... This practice, often justified by safety concerns with multiple-arterial grafting (MABG), defies evidence of improved late survival achieved with bilateral ITA ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2019.08.1043

Outcomes of Second Arterial Conduits in Patients ... Multiarterial CABG was associated with lower 10-year myocardial infarction (hazard ratio: 0.81; 95% confidence interval: 0.69 to 0.95) and lower ...