Coronary Artery Bypass Grafting, Coronary Artery Disease
Conditions
Keywords
Total Arterial Revascularization, Y-Graft, In-Situ, Coronary Artery Bypass Grafting
Brief summary
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.
Detailed description
The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.
Interventions
PROCEDUREY-Graft
Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
PROCEDUREIn-Situ
In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
Sponsors
Kemerovo Cardiology Center
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Coronary Artery Disease * Stable angina * The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization * Informed Consent Form
Exclusion criteria
* The diameter of the target arteries is less than 1 mm * Stenosis of the subclavian arteries more than 60% * STEMI less than 3 month * Previous cardiac surgery * BMI \>35 * COPD with FEV1 \<60% * Concomitant pathology that requires simultaneous surgical treatment * Cancer with life expectancy less than 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from MACCE | 5 years | Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft patency | 5 years | Graft patency in 5 years |
| Quality of life (SF-36) | 5 years | Assessment of the patient's quality of life by the Short Form-36 in 5 years |
| Treadmill stress test | 5 years | Non-invasive diagnosis of myocardial ischemia |
Countries
Russia
Contacts
Primary ContactDmitry A Sirota, MD
Outcome results
None listed