Aims: To estimate the long-term results of effectiveness and safety second and third generations drug-eluting stents implantations in patients with coronary artery disease.
Methods and results: 367 patients were included in the study, which were randomized into 2 groups. Group I consisted of patients (n=192), which performed PCI with third generation biodegradable-polymer drug-eluting stents. Group II consisted patients (n=175), which performed PCI with second generation drug-eluting stents (Everolimus). Angiographic characteristics of patients:228 patients were 1–2 vessel diseases 86 patients were chronic total occlusions, 53 patients were bifurcation lesions. Inclusion criteria: stable angina (NYHA functional class II-III), myocardial ischemia confirmed stress tests. Exclusion criteria: LMCA diseases, acute coronary syndrome, multivessel diseases (SYNTAX score >32). 7-years results were followed in 183 patients from the Group I and 169 patients from the Group II. Primary endpoints: frequency of MACE (death, MI, repeat intervention). Secondary endpoints: restenosis and late stent thrombosis according to digital angiography, IVUS and OCT.
The survival rate in the late period was 96% in both groups. The frequency of MACE in both groups was 5.4 and 6.5%, respectively (p>0.05). The frequency of restenosis in Group I was 17.5%, in Group II - 8.3% (p<0.001). In this case, repeat revascularization (TLR) was needed in 8.7% of patients in Group I, and in 5.3% of patients in Group II (p<0.05). Stent thrombosis was diagnosed in 3 (1.6%) patients (2 in the RCA and 1 in the LCA) in Group I and 2 (1.2%) patients in Group II (in the LCA) (Ñ'>0.05). The frequency of intraoperative stent malposition according IVUS/OCT was in 187 patients. Post-dilatation by high pressure balloon catheter was performed in 73% of patients. Exercise tolerance after PCI in both groups was not significantly different and averaged 129,64±21,03 and 126,84±22,13Vt respectively (p=0.0423).
Conclusions: 7-years results of second and third generation's drug-eluting stents implantation did not show significant differences frequency of MACE. However, Biolomus-eluting stents showed poorer results on frequency of restenosis,as compared with Everolimus-eluting stents.