Drug-coated balloon catheters in the treatment of bifurcation stenosis of the left main coronary artery: results of a two-year follow-up

Purpose. To evaluate the long-term (24 months) results of drug-coated balloon catheters in the treatment of bifurcation stenoses of the left main coronary artery (LMCA). Methods. A controlled, randomized, prospective study included 150 patients who underwent provisional T-stenting left main coronary artery were included in the study. Patients were randomised into 2 groups by envelope method. In group 1 (n = 75) – final kissing-dilatation after provisional LMCA T-stenting was performed with a drug-coated balloon (DCB) – in the lateral bifurcation branch and with a standard uncoated balloon catheter – in the main branch. In group 2 (n = 75) – final kissing-dilatation was performed with a non-plaque balloon catheter in both the main and lateral bifurcation branches. Patients of both groups were additionally randomised into subgroups of ‘true’ and ‘false’ bifurcation stenoses (Medina classification). Inclusion criteria: bifurcation lesions of the left main coronary artery according to intravascular imaging methods (OST, IVUS); side branch diameter of at least 2.5 mm; confirmed myocardial ischemia in the bifurcation lesion basin (according to FFR, exercise tests, scintigraphy); stable angina of functional class II-IV or proven painless ischemia. Exclusion criteria: implantation of two stents for bifurcation lesion of the LMCA (culotte/crush); severe calcification of the LMCA; extended lesion (more than 25 mm); acute coronary syndrome; previous interventions on the LMCA; side branch diameter less than 2.5 mm; patient’s refusal of intervention. The long-term results were evaluated after 24 months. Results. The long-term results were followed up in 133 patients. After 24 months, the rate of restenosis at the side branch orifice was significantly higher in Group 2 compared to Group 1, amounting to 19.2% and 8%, respectively (p = 0.044) (method used: Pearson Chi-square). However, when analyzing the cumulative MACE value after 24 months, no statistically significant differences were found (p = 0.303) (method used: Pearson Chi-square). Conclusions. The use of drug-coated balloon catheters in patients with bifurcation stenosis of the left main coronary artery is an effective and safe method of treatment, and in some cases, it is the most effective and safe method of treatment.