One-year comparison of radial artery versus no-touch saphenous vein grafts in women having coronary bypass surgery

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

This test compares whether a radial artery graft or a 'no-touch' saphenous vein graft stays open better for one year in women undergoing coronary bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06179329 on ClinicalTrials.gov

What this trial studies

This is a randomized comparison enrolling women having primary isolated coronary artery bypass grafting with three-vessel disease to receive either a radial artery graft or a saphenous vein graft harvested with a no-touch technique to the second-best coronary target. Eligible participants have left ventricular ejection fraction over 35% and target vessels of at least 1.5 mm with ≥70% proximal stenosis. Patients are randomized at the time of surgery and followed for graft patency at one year using clinical follow-up and imaging. The primary outcome is one-year graft patency in the treated target vessel territory.

Who should consider this trial

Good fit: Women aged 18 to 74 undergoing primary isolated CABG with three-vessel coronary disease, target vessels ≥1.5 mm and ≥70% proximal stenosis, and left ventricular ejection fraction >35% are ideal candidates.

Not a fit: Patients with poorly controlled diabetes (HbA1c >8%), emergency/salvage surgery needs, severe renal failure (creatinine clearance <30 mL/min), or unsuitable target vessels are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the results could identify the graft type that keeps arteries open longer in women and reduce the need for repeat procedures.

How similar studies have performed: Previous studies have shown radial artery grafts often have superior long-term patency and no-touch saphenous vein techniques improve vein graft outcomes compared with conventional harvesting, but direct randomized comparisons specifically in women are limited.

Eligibility criteria

Inclusion Criteria:

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:

1. Preoperative conditions:

   1. Lack of the patient's written informed consent.
   2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>8 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.

Where this trial is running

São Paulo, São Paulo

• Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Omar AV Mejia, MD, PhD — InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
• Study coordinator: Omar A V Mejia, MD, PhD

Conditions Cardiac Disease; Surgery-Complications; Graft Failure; Cardiovascular Surgery; Coronary Disease; Women; Graft patency