An interventional study of Coronary artery bypass graft in Cardiac Disease, Surgery-Complications and Graft Failure, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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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:
Preoperative conditions:
Inability to use the saphenous and/or radial vein
Conditions that may affect patient follow-up
Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory
Procedure: Coronary artery bypass graft
Radial artery graft for the territory of the right coronary artery and "no-touch" saphenous vein for the anterolateral wall.
Procedure: 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.
One Follow-up with angiography
The primary endpoint will be the proportion of saphenous vein and radial artery grafts that were completely occluded on follow-up angiography
Time frame: One year after surgery
Evaluate in-hospital clinical outcomes 30 days after CABG
Death from any cause, perioperative myocardial infarction (occurring between 0 and 30 days), late myocardial infarction (occurring between 31 days and 1 year), reoperation of surgical revascularization and/or coronary angioplasty. Hand claudication and thenar paresthesia, complications potentially related to radial artery extraction, will be reported according to the specific diagnoses and confirmed with a consulting neurologist. As all patients will receive a radial artery graft, clinical events will be reported for the entire study population.
Time frame: Thirty days after surgery
Plan to share: No
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University of Sao Paulo General Hospital