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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Disease, Surgery-Complications, Graft Failure

Intervention / Treatment
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* Procedure: Coronary artery bypass graft


Participation Criteria
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Eligibility Criteria
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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: Preoperative conditions: Lack of the patient's written informed consent. Presence of poorly controlled diabetes, with a glycated hemoglobin value >7 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radial - Anterolateral / Saphenous - RCA<br>Radial artery graft for the anterolateral wall, and no-touch saphenous vein graft for the right coronary artery territory | Procedure: Coronary artery bypass graft<br>* 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.<br>|
| Other: Radial - RCA / Saphenous - Anterolateral<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Thirty days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Surgery, Coronary Disease, Women, Graft patency