Evaluation of effectiveness of combined treatment of coronary heart disease - Coronary artery bypass grafting, transplantation of autologous bone marrow mononuclear cells: A randomized, blind placebo-controlled study

Abstract

Introduction. Despite the undoubted success in treating patients with coronary heart disease (CHD), it is not yet possible to achieve a significant reduction in mortality in this disease. Taking this in account, at present, studies is being done everywhere on the search of new methods in order to increase the efficiency of existing standards. One of such promising techniques is cellular/regenerative therapy with autologous bone marrow mononuclear cells (AMNCM). However, despite the fact, that AMNCMs have been studied for more than 10 years, clear data, on a number of questions, have not been received, yet. Aim: to evaluate the results of AMNCM transplantation during the performance of aorto-coronary bypass surgery (CABG) in the combined treatment of coronary artery disease. Materials and methods. The data of 408 patients, admitted to the clinic from 2013 to 2016 years, for planned surgical treatment of coronary artery disease were analyzed. In work enrolled 117 patients, according to the design of the study. Patients were randomized in 3 groups: group 0 - CABG operation and intramyocardial injection of 0.9% NACL solution, group 1 - CABG operation and intramyocardial injection of AMNCM, group 2 - CABG operation and intramyocardial and intragraft injection of AMNCM. After 12 months an assessment of the dynamic was made - functional class of angina pectoris and heart failure, echocardiography, speckle tracking, treadmill test, 6-minute walk test, daily ECG monitoring, quality of life questionnaires, coronary angiography. Qualitative indicators were calculated using Pearson (χ2), and Fisher criteria. Quantitative indicators were calculated using criteria Kruskal-Wallis and Wilcoxon. A factor analysis to identify certain severity factors and study data homogeneity was applied. To study the leading characteristics that determine the differentiation between groups, discriminant analysis was chosen. For analysis of variance, taking into account various factors, the model of variance for dependent samples Repeated Measures ANOVA was used. Results. In the observation groups, improvement in both systolic and diastolic myocardial function was universally noted. Test with a 6-minute walk showed a statistically significant increase in groups 1 and 2 as compared with the control: group 0 - 315,06 ± 17,6 (433,54 ± 20,6), group 1 - 319,8 ± 24,5 (524,4 ± 28,7), group 2 - 329,9 ± 25,3 (452,7 ± 29,7) meters. A significant decrease in the functional class of angina pectoris in groups 1 and 2 as compared with the control group. The percentage of functioning coronary shunts after 12 months of follow-up was 87,6% in group 0, in groups 1 and 2 this ratio was 96,2% and 97,3% respectively. Predictors of overall effectiveness were identified: smoking, initial diastolic myocardial dysfunction, ejection fraction of the left ventricle. Conclusion. AMNCM transplantation, in addition to the surgical treatment of coronary heart disease, can improve myocardial contractility, increase exercise tolerance, and increase the duration of functioning of coronary shunts at the follow-up period of 12 months. The study showed the need for stage-by-stage analytical calculations with the aim of possible correction of further work.