Aim: To evaluate the effectiveness of drug-eluting balloons in patients with Left Main (LM) bifurcation stenosis.
Material: 128 patients with true bifurcation lesions of the LM were included in the study. All patients underwent “Provisional T” stenting of the LM coronary artery with the final kissing-dilatation technique. Depending on the balloon catheters used for the final kissing, the patients were randomized into 2 groups. Group I (n=64) - a kissing-dilatation performed with traditional NC balloon catheters, and group II (n=64) - 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 addition, patients from group II also underwent kissing-predilatation with drug-eluting balloon catheters. Inclusion criteria: true bifurcation stenosis of the LMCA from QSA and IVUS data; SYNTAXscore <32. Primary endpoints: incidence of MACE - death, MI, re-interventions.
Results: All patients were implanted with drug-eluting stents. Survival of patients after PCI was 100% in both groups. All interventions are performed without complications. 6-month results were analyzed in all patients. After 6-months no cases of MACE were observed. In 3 patients (4.7%), group I showed signs of new-intima hyperplasia (restenosis up to 50%), repeated interventions were not performed. 12-month results were followed in 52 patients from group I and 48 patients from group II. In 1 patient (1.9%) from group I, and 1 patient (2.1%) from group II (p>0.05) there was a recurrence of angina. Myocardial ischemia is confirmed by stress tests, coronary angiography revealed stent restenosis up to 80%. Both patients underwent repeated interventions. Restenosis of the side branch of less than 50% according to QSA was detected in 5 patients (9.6%) from group I and in 4 patients (8.3%) from group II (p>0.05). In patients from group I, the average MLA in the side branch (LCX) after 12 months was 5.58±1.34 and 4.21±1.21 mm, respectively (p<0.05), compared with data after PCI; in the ostium of the side branch (LAD) - 6.34±1.56 and 5.28±1.14, respectively (p<0.05). In patients from Group II, the average MLA at the end of PCI and after 12 months were, respectively, 5.38±1.24 and 5.11±1.44 mm for the ostium of LCX (p>0.05) and 6.68±1.75 and 6.46±1.22 mm for the ostium of LAD (p<0.05). All patients had complete stent endothelization, with no signs of malapposition. There were no cases of late thrombosis of the stents.
Conclusion: The use of drug-eluting balloon catheters to perform “Provisional T” stenting of true LM bifurcation stenoses is highly effective and safe, as evidenced by a significant low incidence of restenosis of the side branch according to intravascular imaging methods without affecting the MACE frequency and can be considered as an alternative two-stent strategy of bifurcation stenting.