Study of the No-touch Saphenous Vein Graft

A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.

• Сoronary bypass surgery according to the I-graft method (Procedure): Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft.
• Сoronary bypass surgery by the method of free conduit (Procedure): Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

Primary outcomes

• Patency of "no-touch" saphenous vein graft [12 months after surgery]: Assessment of the patency of coronary shunts

Secondary outcomes

• Recurrence of angina pectoris [6 and 12 months after after surgery]: Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
• MACE [6 and 12 months after after surgery]: Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery
• Complications of the conduit fence site [6 and 12 months after after surgery]: Estimated percentage of participants with wound complications, development of wound infection, postoperative neurological complications at the sampling site at 6 and 12 months after surgery
• Survival rate [6 and 12 months after after surgery]: Estimated percentage of participants who died at 6 and 12 months after surgery

Sex: All, ages: 25 Years to 70 Years

Inclusion Criteria:

* Patients with coronary artery disease requiring three-vessel myocardial revascularization
* Patient consent to the study

Exclusion Criteria:

* The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
* Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
* Stenosis of the right coronary artery less than 90%
* Concomitant pathology requiring additional simultaneous surgical correction
* Lack of IMA
* COPD with FEV1 <60%
* BMI >35
* Prior heart surgery
* Oncological diseases with a life expectancy of less than 5 years
* ACS
* CKD stage 4 and higher
* The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
* CLTI IIb and more
* Atherosclerosis of the brachiocephalic artery more than 50%

• Dmitry Khvan, Ph.D., Principal investigator, NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian