RecruitingNot ApplicableNCT06179329

One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG

No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial

Sponsor

University of Sao Paulo General Hospital

Enrollment

150 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiac Disease Surgery--Complications Graft Failure

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

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 Criteria14

Preoperative conditions:
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.
Inability to use the saphenous and/or radial vein
Positive Allen test using a pulse oximeter
Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
Conditions that may affect patient follow-up
Presence of advanced peripheral arterial disease
Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
Impossibility of tracking due to geographic inaccessibility.
Patients with lack of adherence to guidelines and/or prescribed medications.

Interventions

PROCEDURECoronary 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.