Randomization of Single vs Multiple Arterial Grafts
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 6/1/2018 |
| Start Date: | January 7, 2018 |
| End Date: | March 31, 2022 |
| Contact: | Mario Gaudino, MD |
| Email: | mfg9004@med.cornell.edu |
| Phone: | 212.746.1812 |
Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent
coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a
single arterial graft is associated with a reduction in the composite outcome of death from
any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG,
the use of two or more arterial grafts compared to a single arterial graft is associated with
improved survival.
Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects
enrolled in at least 25 international centers. Patients will be randomized to a single
arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1
fashion between the two groups. Permuted block randomization with random blocks stratified by
the center and the type of second arterial graft will be used to provide treatment
distribution in equal proportion.
coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a
single arterial graft is associated with a reduction in the composite outcome of death from
any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG,
the use of two or more arterial grafts compared to a single arterial graft is associated with
improved survival.
Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects
enrolled in at least 25 international centers. Patients will be randomized to a single
arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1
fashion between the two groups. Permuted block randomization with random blocks stratified by
the center and the type of second arterial graft will be used to provide treatment
distribution in equal proportion.
In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing
coronary surgery when the left anterior descending (LAD) was grafted with a left internal
thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at
least in part, due to greater and more durable patency of the left ITA compared to an
increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts
(SVG) (2).
For more than 20 years it has generally been accepted that patients who receive multiple
arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased
postoperative survival compared to those who receive only one AG, especially over the long
term (3-5). The current United States and European Guidelines encourage the use of AGs in
patients with a long life expectancy (6, 7). Last year, a position paper from the Society of
Thoracic Surgeons strongly recommended a wider use of AGs (8).
The putative mechanism underlying the AG hypothesis is greater patency. In line with the
original findings of improved LAD graft patency with ITA vs. SVG, data from randomized
control trials (RCTs) as well as observational studies and a network meta-analysis (9) have
demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG,
providing mechanistic basis to support the AG hypothesis.
ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact
of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any
stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is
powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.
The primary aim is to conduct a multicenter international randomized control trial to test
the hypothesis that the use of a two or more AGs compared to a single arterial graft is
associated with a reduction in the composite outcome of death from any cause, any stroke,
post discharge myocardial infarction and/or repeat revascularization.
The secondary aim is to conduct a multicenter international randomized control trial to test
the hypothesis that the use of two or more AGs compared to a single arterial graft is
associated with improved survival.
coronary surgery when the left anterior descending (LAD) was grafted with a left internal
thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at
least in part, due to greater and more durable patency of the left ITA compared to an
increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts
(SVG) (2).
For more than 20 years it has generally been accepted that patients who receive multiple
arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased
postoperative survival compared to those who receive only one AG, especially over the long
term (3-5). The current United States and European Guidelines encourage the use of AGs in
patients with a long life expectancy (6, 7). Last year, a position paper from the Society of
Thoracic Surgeons strongly recommended a wider use of AGs (8).
The putative mechanism underlying the AG hypothesis is greater patency. In line with the
original findings of improved LAD graft patency with ITA vs. SVG, data from randomized
control trials (RCTs) as well as observational studies and a network meta-analysis (9) have
demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG,
providing mechanistic basis to support the AG hypothesis.
ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact
of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any
stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is
powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.
The primary aim is to conduct a multicenter international randomized control trial to test
the hypothesis that the use of a two or more AGs compared to a single arterial graft is
associated with a reduction in the composite outcome of death from any cause, any stroke,
post discharge myocardial infarction and/or repeat revascularization.
The secondary aim is to conduct a multicenter international randomized control trial to test
the hypothesis that the use of two or more AGs compared to a single arterial graft is
associated with improved survival.
Inclusion Criteria:
- Primary isolated CABG patients with disease of the left main coronary artery and/or of
the left anterior descending and the circumflex coronary system with or without
disease of the right coronary artery.
Exclusion Criteria:
- Age > 70 years
- Single graft
- Emergency operation
- Evolving myocardial infarction within 48 hours of surgery
- Left ventricular ejection fraction of < 35%
- Any concomitant cardiac or non-cardiac procedure
- Previous cardiac surgery
- Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory
failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
- Inability to use the saphenous vein or to use both radial and right internal thoracic
arteries
- Anticipated need for coronary thrombo-endarterectomy
- Planned hybrid revascularization
We found this trial at
1
site
525 East 68th Street
New York, New York 10065
New York, New York 10065
Phone: 212-746-1815
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