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

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Graft Failure; Surgery-Complications; Cardiac Disease

Treatments: Procedure: Coronary artery bypass graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06179329

5723/23/125

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Women aged 18 years or older and younger than 70 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 >7 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Radial - Anterolateral / Saphenous - RCA

Other group

Description:

Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory

Treatment:

Procedure: Coronary artery bypass graft

Radial - RCA / Saphenous - Anterolateral

Other group

Description:

Radial artery graft for the territory of the right coronary artery and "no-touch" saphenous vein for the anterolateral wall.

Treatment:

Procedure: Coronary artery bypass graft