Aims: To evaluate long-term results of endovascular treatment in patients with bifurcation left main coronary artery diseases.
Methods and results: 284 patients were enrolled in the study, which randomized into 2 groups: group I (n=132) were included patients with true bifurcation lesions, which implanted Everolimus-eluting stents, and group II (n=152) – were non-bifurcations, which implanted Paclitaxel-eluting stents. The both groups were additionally randomized into 2 subgroups: subgroup IA, IIA (n=66 in each subgroup) - included patients, who underwent 1-stent bifurcation strategy and subgroup IB, IIB (n=76 in each subgroup) - who underwent 2-stent strategy (Culotte and Crush/Mini-Crush). For all patients, who underwent 2 stents in bifurcation, were performing subanalysis, depending on the technique of bifurcation stenting. Inclusion criteria: true and non-bifurcation lesions of left main coronary artery + 1 or 2 vessel diseases (SYNTAX score <32); stenosis of the left main coronary artery, confirmed by FFR<0.8; stable angina classes II-IV (CCS). Primary endpoints: MACE. Secondary endpoints: restenosis and late stent thrombosis according to digital angiography and IVUS.
In group I, who implanted Everolimus-eluting stents, MACE was 5.3%. In group II, who implanted Paclitaxel-eluting stents, frequency of MACE was 7.2% (p=0,003). The ratio of restenosis in bifurcation area, according digitalangiographyin both groups was 6.8 and 9.8% respectively (p=0.0024). Ratio of TLR in both groups amounted 4.5 and 6.5% respectively (p=0.004). IVUS-results in subgroup IA and IIA:the average residual lumen area in the proximal part of LMCA was 7,02+0,03 and 7.55+0.02 mm2 (p>0.05), at the ostia of the LCx - 5,0+0,12 and 5,88+0,01 mm2 (p=0.02), at the ostia of the LAD - 6,13+0,03 and 6.88+0,04 mm2 (p=0.03). The MACE in subgroup IA and IIA was 9.1 and 1.5% respectively (p<0.001). IVUS-results in subgroup IIA and IIB:the average residual lumen area in the proximal part of LMCA was 7,22+0,03 and 7.55+0.02 mm2 (p>0.05), at the ostia of the LCx - 5,0+0,12 and 5,64+0,01 mm2 (p=0.024), at the ostia of the LAD - 6,0+0,03 and 6.84+0,04 mm2 (p=0.027). The MACE in subgroup IB and IIB was 10.5 and 3.9% respectively (p<0.001).142 patients in the study were implanted two stents at the bifurcation. The distribution of patients according to the stenting technique was equivalent, with 70 in each group. The MACE in Culotte and Crush/Mini-Crushgroups was 0 and 5.7% respectively (p<0.001). Defined stent thrombosis were no significant difference in both groups.
Conclusions: Everolimus-eluting stents associated with higher efficacy and safety in bifurcation stenting of left main coronary artery, compared with Paclitaxel-eluting stents. Culotte-technique of LMCA bifurcation stenting shows better long-term results, as compared to Crush/Mini-Crush-technique. Two-stent strategy can be the preferred for endovascular treatment of true left main coronary artery bifurcation lesions.