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

Not Applicable

Not yet recruiting

• Conditions: Surgery-Complications; Cardiac Disease; Graft Failure

• Registration Number: NCT06179329
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Study Start: 2024-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
One Follow-up with angiography	One year after surgery	The primary endpoint will be the proportion of saphenous vein and radial artery grafts that were completely occluded on follow-up angiography

Secondary Outcome Measures

Name	Time	Method
Evaluate in-hospital clinical outcomes 30 days after CABG	Thirty days after surgery	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.

Trial Locations

Locations (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo; 🇧🇷 São Paulo, Brazil