Coronary Artery Atherosclerosis
Conditions
Keywords
Coronary artery atherosclerosis, no-touch vein, radial artery
Brief summary
This study examines the outcomes of coronary artery bypass grafting (CABG) in women at 1 year after surgery. A randomized controlled trial is planned, including a comparative analysis of two observed groups depending on the chosen conduit for revascularization of the circumflex artery. The main group is supposed to include 55 patients undergoing CABG with the use of the radial artery, while the control group will include 55 patients undergoing CABG with the use of the great saphenous vein prepared using the no-touch technique.
Detailed description
The Raventa trial is a prospective, unblinded, randomized single centre trial comprising 110 subjects. Women with left main and/or multivessel disease will be randomized to radial artery (RA) or no-touch vein (NV) grafts to the left coronary system in a 1:1 fashion. The primary outcome will be the ratio of functioning and closed radial artery and no-touch vein bypass grafts in the groups one year after surgery. The secondary outcomes will be: 1. Difference in the composite rate of major adverse cardiac and cerebrovascular events (MACCE) between the groups at 30 days and 12 months after the procedure. For the purposes of this study, MACCE components include all-cause mortality, stroke, myocardial infarction and/or repeat revascularization. 2. Difference in the incidence of complications (hemorrhagic, neurological, infectious, arrhythmological) between the groups. 3. Difference in angina class between the groups at one year after the procedure. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the NV group, saphenous no-touch vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the RA group, the main target vessel of the lateral wall will be grafted with radial artery. Additional grafts can be saphenous veins or supplemental arterial conduits at the surgeon's discretion. Screening. The screening period will last from the patient's admission to the hospital until the day before surgery. Eligibility for this study will be determined based on the results of routine clinical and instrumental examinations, conducted in accordance with existing clinical practice standards and the Cardiology Research Institute's protocols for this patient category, including coronary angiography, ultrasound, and general clinical tests. Follow-up period: 12 months after surgery. During this period, information on the disease course and intervention outcomes will be collected. Data on secondary endpoints 1 and 2 will be collected within 30 days postoperatively. A follow-up assessment of the study participants' vital status will be performed in 12 months after surgery, identifying MACCE (all-cause mortality, repeat revascularization, stroke, and myocardial infarction) as well as examining coronary bypasses to assess the primary endpoint and secondary endpoints 1 and 3.
Interventions
PROCEDUREradial artery graft
Circumflex artery territory revascularization using the radial artery graft
PROCEDUREno-touch vein graft
Circumflex artery territory revascularization using a no-touch vein graft
Sponsors
Tomsk Cardiology Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Three-vessel disease involving the target circumflex artery with stenosis ≥70% and a diameter ≥1.5 mm 2. Females aged 18 years and older 3. Signed informed consent 4. Clinical indications for coronary revascularization (refractory angina/transient myocardial ischemia according to noninvasive tests)
Exclusion criteria
1. Previous cardiac surgery of any type, including CABG 2. Combined procedures 3. Ineligibility for venous or radial artery harvesting as determined by preoperative Doppler flowmetry or clinical examination that would compromise graft patency. 4. Acute myocardial ischemia 5. EF less than 35% 6. CKD 4.5 7. Inability to understand the nature, scope, and consequences of the clinical trial, or to provide written informed consent due to cognitive impairment or mental illness. 8. Life expectancy less than 1 year due to non-cardiac diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of functioning and closed shunts in both groups | during follow-up time - 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases) | Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months) | Between groups at 30 days and 12 months after surgery. |
| Complications (percent) | Early postoperative (up to 2 weeks) | Complication rates between groups |
| Change in angina class (percent) | Through study completion, an average of 1 year | one year after surgical revascularization in the compared groups |
Countries
Russia
Contacts
CONTACTVasily V. Zatolokin, PhD
CONTACTDanil V. Timofeev
PRINCIPAL_INVESTIGATORYuri Y. Veshersky, MD, PhD
Cardiology Research Institute, Tomsk National Research Medical Center
Outcome results
None listed