Cardiac Disease, Graft Failure, Surgery-Complications
Conditions
Keywords
Cardiovascular Surgery, Coronary Disease, Women, Graft patency
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.
Interventions
PROCEDURECoronary 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.
Sponsors
Instituto Nacional de Cardiologia
Hospital Unimed João Pessoa
Hospital do Coração Alagoano Prof. Adib Jatene
Hospital Hernan Henriquez Aravena
Hospital Norte Paranaense
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactOmar A V Mejia, MD, PhD
Backup ContactLeonardo L Lacava, MD
Outcome results
None listed