Efficacy of drug-eluting balloon catheters in the treatment of left main coronary artery bifurcation stenosis: a 12-month follow-up

Objective. To evaluate the efficacy of drug-eluting balloon catheters (DEBC) in the treatment of left main coronary artery (LMCA) bifurcation lesions. Material and methods. The study included 150 patients who underwent provisional T-stenting of LMCA bifurcations. Patients were randomized into 2 groups. In group 1 (n=75), provisional T-stenting of LMCA was followed by final «kissing» with DEBC in side branch of bifurcation and standard non-compliant balloon catheter in the main branch. In group 2 (n=75), final “kissing” was performed with non-compliant balloon catheter in main and side branches of bifurcation. In addition, patients in both groups were randomized into subgroups according to Medina type of lesion (“true” and “false” bifurcation stenosis). The follow-up period was 12 months. Primary endpoints: cumulative incidence of major adverse cardiac events (MACE) — cardiac death, myocardial infarction, repeated interventions; restenosis at the ostium of the side branch. Treatment results were assessed using stress echocardiography, coronary angiography and intravascular imaging. Results. After 12 months, the total incidence of MACE was higher in group 2 compared to group 1 (6.4% and 2.7%, respectively, p=0.264). The incidence of restenosis at the side branch ostium in patients with «true» and «false» bifurcation stenoses did not differ significantly in within-group comparison (2.9% and 2.4% for group 1; 6.8% and 5.9% for group 2, respectively, p>0.05). However, between-group comparison of these indicators revealed significant differences in patients with «true» stenoses. The incidence of restenosis was 2.9% and 6.8%, respectively (p=0.043). Significant loss of vascular lumen at the mouth of the lateral branch was noted in group 2 among patients with “true” LMCA bifurcations compared to data at the end of surgery. Thus, residual lumen area at the side branch ostium after surgery was 8.2±0.77 mm2, after 12 months — 5.2±0.13 mm2 (p=0.0246). At the same time, there was no significant decrease of residual lumen in patients with «false» LMCA bifurcations in this group (6.9±0.46 and 5.8±0.27 mm2, respectively, p=0.866). In group 1, we found no significant difference when comparing residual lumen area at the mouth of the side branch early after surgery and 12 months later regarding «true» and «false» bifurcations. Conclusion. DEBC in patients with «true» and «false» LMCA bifurcation stenosis has shown equally high efficacy in reducing the incidence of side branch restenosis and target lesion revascularization compared to standard non-compliant balloon catheters. This is confirmed by intravascular imaging and intracoronary physiology data.