Aim To evaluate the long-term results of the use of drug-eluting balloon catheters in patients with Left Main (LM) bifurcation stenosis. Methods The analysis involved 142 patients with true bifurcations of the Left Main. Randomization in 2 main groups: Group I (n=52) included patients, who received kissing- dilatation with traditional NC balloon catheters and Group II (n=52), who had a kissing-dilatation of the main bifurcation artery with a traditional NC balloon catheters, and a side branch - with drug-eluting balloon catheters. In retrospectively, the third (III) control group (n=38) was formed, where the two-stent technique was performed. All patients from main groups had previously performed “Provisional T” stenting and final “kissing balloons” dilation technique. Coronary angiography and OCT were performed to evaluate the results of all patients. Inclusion criteria: true LM bifurcation stenoses according to QCA and OCT; SYNTAX score <32. Primary endpoints: incidence of MACE - death, MI, re-interventions. Secondary endpoints: the incidence of restenosis and late stent thrombosis. Results The long-term results after 4-years were observe in 46 patients from Group I and 48 patients from Group II. Restenosis of the side branch of more than 50% according to QCA was detected in 12 patients (26.0%) from Group I and in 5 patients (10.4%) from Group II (p<0.05). In-stent restenosis of the main vessel of more than 50% according to QCA was detected in 4 patients (8.6%) from Group I and in 1 patients (2.1%) from Group II (p<0.05). In patients from group I, the average MLA in the side branch after 4-years compared with data after PCI was 5.58±1.34 and 4.12±1.21 mm2, respectively (p<0.05), in the main branch – 6.34±1.56 and 5.88±1.14 mm2, respectively (p>0.05). In patients from Group II, the average MLA were, respectively, 5.38±1.24 and 5.01±1.14 mm2 in side branch (p>0.05) and 6.68±1.75 and 6.36±1.22 mm2 in main branch (p>0.05). When comparing the data of MLA in the side branch in groups I and II, there was a significant difference (4.12±1.21 vs. 5.01±1.14 mm2; p<0.05).The repeat revascularization, in connection with the detected ischemia was performed in 7 patients (15.2%) from Group I and in 1 patients (2.1%) from Group II (p<0.05). In the Group I was observed non-fatal myocardial infarction in 2 patients (4.3%). The total incidence of MACE were 19.5 vs. 2.1% in groups I and II respectively (χ2=7.321; p<0.001). The survival without MACE was 97.9 and 80.5%, respectively (p=0.0219). Conclusions The use of dug-eluting balloon catheters for the “Provisional T” stenting in patients with true LM bifurcation stenosis, associated with good prognosis and demonstrated significantly lower frequency of MACE and side branch restenosis, according to OCT data, compared with patients who used traditional NC balloon catheters for “kissing-dilatation” and two-stent technique strategy. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Russian academic excellence project 5-100

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Highlights. Two-year results of stenting in patients with diffuse and multivessel coronary artery lesions performed using intravascular research and control methods (optical coherence tomography, blood flow fractional reserve) are presented. A low incidence of myocardial infarction, repeated interventions and a high level of survival, free from significant cardiovascular complications, were noted when using intravascular research methods in patients during percutaneous coronary intervention in comparison with the patients who did not undergo intravascular methods.Aim. To evaluate the two-year results of percutaneous coronary interventions (PCI) in patients with diffuse and multivessel coronary lesions.Methods. 128 patients were included in the study and divided into two groups. In group I (n = 62) PCI was performed using intravascular imaging methods, in group II (n = 66) no intravascular imaging methods (retrospectively) were used. The measurement of fractional flow reserve (FFR) in diffusely altered arteries was performed against the background of maximum hyperemia between stenoses by pulling the sensor starting from the distal segment. Initially, the most distal hemodynamically significant stenosis underwent the stenting. Then, a repeated measurement of FFR was performed and it showed if the further stenting was needed. The results of stenting, as well as the determination of the stent implantation area were carried out by the method of optical coherence tomography.Results. 12 months after PCI the results of treatment were checked in all patients and after 24 months – in 106 patients (56 and 50, respectively, in groups I and II). The achievement of complete (functionally adequate, according to FFR measurements) myocardial revascularization was achieved in 93.5% of patients from group I, while the result in the control group was only 56% of patients. The average number of stenoses in the target non-occluded artery according to angiography and after FFR measurement was the following: in patients with two-vessel lesions – 2.95±0.65 and 1.82±0.88, respectively, and in patients with three-vessel lesions – 2.96±0.6 and 2.24±0.76, respectively (p = 0.0024). After 12 months of follow-up, significant differences were observed between groups I and II in the frequency of myocardial infarction (1.8 and 4.0%, respectively; χ2 = 5.172) and repeated interventions (3.6 and 16.0%, respectively; χ2 = 8.114). By the 24th month of follow-up, among the observed patients, the total frequency of myocardial infarction, repeated interventions and cardiac death were significantly higher in patients of group II compared with group I and they were 45.5 and 9.6%, respectively (χ2 = 14.784; p<0,0001).Conclusion. Long-term results of PCI in patients with diffuse and multivessel coronary lesions using intravascular imaging methods (optical coherence tomography and FFR measurements) are characterized by low cardiac complications, compared with patients operated without imaging methods.

Aim To evaluate the efficacy of the sympathetic renal denervation procedure in patients with refractory arterial hypertension and heart failure. Methods The study included 72 patients with refractory arterial hypertension. We used randomization in 2 main groups: the Group I (n=36) included patients, who underwent denervation procedure of the main trunk of the renal artery and the Group 2 (n=36) - included patients who underwent denervation procedure in main trunk and also in second-order renal arteries. Additionally, patients were divided into 2 subgroups: the subgroup A (n=30) included patients, who underwent denervation procedure with a SYMPLICITY catheter, and the subgroup B (n=42) - included patients who underwent denervation procedure with a VESSIX catheter. Also, the renal denervation procedure efficacy, in patients with chronic heart failure (CHF) was analyzed. In all groups, 24-hour blood pressure monitoring, echocardiography and a 6-minute walk test were monitored. Inclusion criteria: refractory hypertension, age of patients 18–85 years, systolic blood pressure (SBP) ≥140/90 mmHg and ≥130/90 mmHg in patients with diabetes mellitus, functioning kidneys, renal arteries ≥40 mm in diameter and the length of the site up to the first bifurcation of at least 20 mm, absence of stenoses in the renal arteries, GFR≥40 ml/min/1.73m2, suitable anatomy of the renal arteries for endovascular procedure. Results 24 months result after the denervation procedure was demonstrated significantly decreased SBP in patients of both groups. In group I, it was, compared with pre-operative data (174.9±1.6 vs. 151.7±2.3 mmHg, respectively; p<0.05), and in group II - 181.9±2.1 vs. 140.4±3.8 mmHg, respectively; p<0.05). However, when comparing SBP values between groups, SBP in group I was significantly higher, than in group II (151.7±2.3 vs. 140.4±3.8 mmHg, respectively; p<0.05). In addition, the average number of drugs in group I was decreased to 2.1±0.8 after 24th month, and in group II - to 1.4±0.6 (p<0.05). When comparing SBP value in subgroup A and subgroup B, the average daily SBP also significantly difference and amounted to 147.8±1.8 vs. 138.4±3.2 mmHg, respectively; p<0.05). Among the all patients included in the study, 38 patients were with CHF. The 6-minute walk test results, compared with pre-operative data, showed a significant improvement and amounted to 321.24±83.22 vs. 212.42±54.72m, respectively; p<0.05. Conclusions The sympathetic renal denervation may be regarded as an effective method of treatment of patients with resistant hypertension, as well as patients with concomitant chronic heart failure. Performing denervation in the arteries of the second order, significantly improves the prognosis of patients, and in patients with concomitant heart failure significantly increases the quality of life and exercise tolerance. Acknowledgement/Funding Russian Academic Excellence Project 5-100