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Drug-eluting balloon catheters in the endovascular treatment of patients with true left main bifurcation lesions
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.
In line with the ESC mission, newly presented content is made available to all for a limited time (4 months for ESC Congress, 3 months for other events). ESC Professional Members, Association Members (Ivory & above) benefit from year-round access to all the resources from their respective Association, and to all content from previous years. Fellows of the ESC (FESC), and Professionals in training or under 40 years old, who subscribed to a Young Combined Membership package benefit from access to all ESC 365 content from all events, all editions, all year long. Find out more about ESC Memberships here.