ROMA WOMEN

Official Title

Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial

Study Purpose

It is the first cardiac surgery trial dedicated exclusively to women. Patients will be randomized in a 1:1 fashion. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG).

Diagnosis

Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography or a fractional flow reserve value ≤ 0.80; a left main diameter stenosis ≥ 50% or a left main intravascular ultrasound minimal luminal area of ≤ 4.5 mm2 will also be considered.

Eligibility

Exclusion

• Males
• Single graft
• Emergency operation
• Myocardial infarction within 72 hours of surgery
• Left ventricular ejection fraction < 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 reduces 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
• Calcified aorta

Intervention

Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG) with non-emergent coronary artery bypass surgery (CABG.)