Single vs Multiple Arterial Grafts for Heart Disease (ROMA:Women Trial)
Recruiting in Palo Alto (17 mi)
+123 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
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.
12345Is 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.
12467How 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.
14568Eligibility 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 have had surgery to improve blood flow to my heart.
I have severe heart artery disease affecting the main or left arteries.
I am a woman aged 18 or older.
I am having my first heart surgery.
I am having my first heart surgery.
I have had surgery to improve blood flow to my heart.
I have severe heart artery disease affecting the main or major side 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.
I am scheduled for a combined surgical and non-surgical procedure to improve blood flow.
I cannot use my saphenous vein or both my radial and right internal thoracic arteries.
I need an emergency surgery.
I had a heart attack less than 3 days before my surgery.
I am undergoing or have undergone other heart or non-heart related surgeries.
I am expected to need surgery to remove blockages from my heart's arteries.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Single Arterial Graft (SAG) groupExperimental Treatment1 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) groupExperimental Treatment1 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)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Massachusetts Chan Medical SchoolWorcester, MA
Methodist Physicians HealthOmaha, NE
Englewood HealthEnglewood, NJ
Institut Universitaire de Cardiologie et de Pneumologie de QuébecSte Foy, Canada
More Trial Locations
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
Maastricht University Medical CenterLead Sponsor
Duke UniversityCollaborator
Oxford University Hospitals NHS TrustCollaborator
New York Presbyterian HospitalCollaborator
Sunnybrook Health Sciences CentreCollaborator
Cedars-Sinai Medical CenterCollaborator
Columbia UniversityCollaborator
University of GöttingenCollaborator
References
Multiple arterial coronary bypass grafting is associated with greater survival in women. [2023]Multiple arterial grafting (MAG) in coronary artery bypass grafting (CABG) is associated with higher survival and freedom from major adverse cardiac and cerebrovascular events (MACCEs) in observational studies of mostly men. It is not known whether MAG is beneficial in women. Our objectives were to compare the long-term clinical outcomes of MAG versus single arterial grafting (SAG) in women undergoing CABG for multivessel disease.
Trend and factors associated with multiple arterial revascularization in coronary artery bypass grafting in the UK. [2022]Benefits of using multiple arterial grafting (MAG), over single arterial grafting in major adverse cardiac event rates and the need for repeat revascularization, have been widely reported. Several guidelines have recommended the use of MAG in selected patients. We report the trend of MAG in patients undergoing isolated coronary artery bypass grafting (CABG) in the UK.
Multiple Arterial Grafting Is Associated With Better Outcomes for Coronary Artery Bypass Grafting Patients. [2019]Observational studies have shown better survival in patients undergoing coronary artery bypass grafting (CABG) with 2 arterial grafts compared with 1. However, whether a third arterial graft is associated with incremental benefit remains uncertain. We sought to analyze the outcomes of 3 versus 2 arterial grafts during CABG. As a secondary objective, we compared CABG with 2 or 3 arterial grafts (multiple arterial grafts [MAG]) with CABG using a single arterial graft (SAG).
Multiple Versus Single Arterial Coronary Bypass Graft Surgery for Multivessel Disease. [2020]Despite recent guideline statements, there is still wide practice variation in the use of multiple arterial grafts (MAGs) versus single arterial grafts (SAGs) for patients with multivessel disease undergoing coronary artery bypass graft surgery. This may be related to differences in findings between observational and randomized controlled studies.
Multiple Versus Single Arterial Coronary Arterial Bypass Grafting Surgery for Multivessel Disease in Atrial Fibrillation. [2022]Observational studies suggest improved outcomes with multiple (MAG) as compared to single arterial grafting (SAG) in patients with multivessel coronary artery disease and undergoing coronary artery bypass grafting (CABG). Even though around 6% of CABG patients have preoperative atrial fibrillation, previous studies did not address MAG versus SAG comparison in this setting. Data from KROK (Polish National Registry of Cardiac Surgery Procedures) were retrospectively collected. 5738 patients with multivessel coronary artery disease and AF (77.9% men, mean age 69.0 ± 8.0) undergoing isolated CABG surgery between 2006 and 2019 in 37 reference centers across Poland were analyzed. Propensity score matching was performed. Primary endpoint was mid-term survival. Median follow-up was 5 years ([IQR 1.9-7.6], max.13). One-to-three Propensity score matching included 2364 patients divided into MAG (591) and SAG (1773) subsets. Subjects were no different in terms of baseline risk and surgical characteristics. Number of distal anastomoses was 2.82 ± 0.83 versus 2.80 ± 0.75 (P = 0.516) for MAG and SAG, respectively. In-hospital outcomes and mortality risk at 1-year (hazard ratio, 95% confidence intervals: 1.13 [0.81-1.58]; P = 0.469) was unchanged with MAG. Multiple arterial grafting was associated with 20% improved mid-term survival: HR 0.80; (95% confidence intervals: 0.65-0.97); P = 0.026. Benefit was sustained in subgroup analyses, yet most appraised in low risk patients (
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]We reviewed the available literature on patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) with either single (SAG) or multiple arterial grafting (MAG).
Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. [2022]The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG).
Meta-Analysis Comparing Multiple Arterial Grafts Versus Single Arterial Graft for Coronary-Artery Bypass Grafting. [2020]Observational studies and randomized controlled trials (RCTs) have shown conflicting outcomes for multiple arterial graft (MAG) coronary artery bypass graft surgery compared with single arterial grafts (SAGs). The predominant evidence supporting the use of MAGs is observational. The aim of this meta-analysis of RCTs is to compare outcomes following MAG and SAG. We searched multiple databases for RCTs comparing MAG versus SAG. The clinical outcomes studied were all-cause mortality, cardiac mortality, myocardial infarction (MI), revascularization, stroke, sternal wound complications, and major bleeding. We used hazard ratio (HR), relative risk (RR), and corresponding 95% confidence interval (CI) for measuring outcomes. Ten RCTs (6392 patients) were included. The average follow-up in the studies was 4.2 years. The average age of the patients in the studies ranged from 56.3 years to 74.6. No significant difference was seen between MAG and SAG groups for all-cause mortality (11.8% vs 12.7%, HR 0.94, 95% CI 0.81 to 1.09, p 0.36), cardiac mortality (4.1% vs 4.5%, HR 0.96 95% CI 0.74 to 1.26, p 0.77), MI (3.5% vs 5.1%, HR 0.87 95% CI 0.67 to 1.12, p 0.28), and major bleeding (3.3% vs 4.9%, RR 0.85 95% CI 0.64 to 1.13, p 0.26). Repeat revascularization in MAG showed a lower RR than SAG when one of the confounding studies was excluded (RR 0.63, 95% CI 0.4 to 0.99, p 0.04). The incidence of stroke was lower in MAG than SAG (2.9% vs 3.9%, RR 0.74 95% CI 0.56 to 0.98, p 0.03). MAG had higher incidence of sternal wound complications than SAG (2.9% vs 1.7%, RR 1.75 95% CI 1.19 to 2.55, p 0.004). In conclusion, MAG does not have a survival advantage compared with SAG but is better in revascularization and risk of stroke. This benefit may be set off by a higher incidence of sternal wound complications in MAG.