About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Lack of the patient's written informed consent.
Presence of poorly controlled diabetes, with a glycated hemoglobin value >8 mg/dl.
Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.
Renal failure with glomerular filtration rate (creatinine clearance) <30 mL/min.
Trial design
Parallel
Treatments tested in this trial
Coronary artery bypass graft
Procedure/SurgeryRandomization 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo General Hospital
Lead sponsor
Instituto Nacional de Cardiologia
Collaborator
Hospital Unimed João Pessoa
Collaborator
Hospital do Coração Alagoano Prof. Adib Jatene
Collaborator
Hospital Hernan Henriquez Aravena
Collaborator
Hospital Norte Paranaense
Collaborator