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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease; Graft Failure; Surgery-Complications
• Intervention / Treatment: Procedure: Coronary artery bypass graft

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar A V Mejia, MD, PhD; Phone Number: +551126615014; Email: omarvmejia@incor.usp.br
• Study Contact Backup: Name: Leonardo L Lacava, MD; Phone Number: +55 49 33224453; Email: lacavalopes@hotmail.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-900
      • Recruiting
      • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
      • Principal Investigator: Maurílio O Deininger, MD, PhD
      • Principal Investigator: Omar AV Mejia, MD, PhD
      • Contact: Omar AV Mejia, MD, PhD; Email: omar.mejia@incor.usp.br
      • Contact: Fabiane L Freitas, BsC; Email: fabiane.freitas@fm.usp.br
      • Principal Investigator: Leonardo L Lacava, MD
      • Principal Investigator: Fabiano G Jucá, MD
      • Principal Investigator: Diego PG Andrade, MD
      • Principal Investigator: Rodrigo C Segalote, MD
      • Principal Investigator: Fabiane L Freitas, BsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radial - Anterolateral / Saphenous - RCA; Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory	Procedure: Coronary 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.
Other: Radial - RCA / Saphenous - Anterolateral; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Instituto Nacional de Cardiologia; Hospital Unimed João Pessoa; Hospital do Coração Alagoano Prof. Adib Jatene; Hospital Hernan Henriquez Aravena; Hospital Norte Paranaense
• Investigators: Principal Investigator: Omar AV Mejia, MD, PhD, InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Women; Coronary Disease; Graft patency; Cardiovascular Surgery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Coronary Disease; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Vascular Grafting; Myocardial Revascularization; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Coronary Artery Bypass
• Other Study ID Numbers: 5723/23/125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No