Coronary artery bypass graft: Randomization will be performed for stratification according to the target coronary arteries and the randomly determined block size from 4 to 6. The randomization result will be delivered in a sealed envelope in the operating room (before the time out) for one of the two drawn strategies.
Study summary
The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the "no-touch" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Women aged 18 years or older and younger than 75 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.
Exclusion Criteria:
1. Preoperative conditions:
1. Lack of the patient's written informed consent.
2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>8 mg/dl.
3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.
4. Renal failure with glomerular filtration rate (creatinine clearance) \<30 mL/min.
2. Inability to use the saphenous and/or radial vein
1. Positive Allen test using a pulse oximeter
2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
3. Conditions that may affect patient follow-up
1. Presence of advanced peripheral arterial disease
2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
3. Impossibility of tracking due to geographic inaccessibility.
4. Patients with lack of adherence to guidelines and/or prescribed medications.
Primary outcome measure(s)
One Follow-up with angiography — One year after surgery The primary endpoint will be the proportion of saphenous vein and radial artery grafts that were completely occluded on follow-up angiography
Trial sites (1)
Facility
City
Region
Status
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo
São Paulo
Recruiting
More University of Sao Paulo General Hospital trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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