Bioabsorbable vascular endoproteases for the treatment of patients with coronary heart disease and type 2 diabetes mellitus

Aim. To evaluate efficiency of endovascular intervention in patients with type 2 diabetes mellitus with the use of bioabsorbable vascular endoproteases and everolimus-coated stents. Material and methods. A total of 143 patients were initially selected for the study of whom 125 were randomized into 2 groups, one including 57 patients with implanted bioabsorbable vascular endoproteases, the other comprised of 68 patients treated with the use of everolimus-coated stents. Inclusion criteria: primary lesion of coronary arteries, stable angina of effort (II-III FC), myocardial ischemia (>10%) confirmed in functional tests, compensated and subcompensated DM2, stenosis of middle and distal segments of the main coronary arteries (≥70%) diagnosed by digital angiography. Exclusion criteria: the target artery not more than 4 mm in diameter, acute coronary syndrome, excess vascular tortuosity, marked calcinosis of coronary arteries, bifurcation lesion, left coronary trunk lesion, history of myocardial revascularization. Criteria for the assessment of immediate outcomes: frequency of major cardiovascular events (death, myocardial infarction, emergency secondary intervention). Criteria for the assessment of long-term outcomes: frequency of major cardiovascular events (death, myocardial infarction, secondary intervention), frequency of in-scaffold/in-stent restenosis or stent thrombosis. Results of biobsorbable scaffold implantation were controlled using optical coherence tomography in the end of surgery and during 12 month during follow-up. Results. A total of 63 bioabsorbable vascular endoprostheses and 102 everolimus-coated stents were implanted to patients of groups 1 and 2 respectively. Mean diameter of the endoprostheses was 2.88±0.06 and 2.68±0.12 mm respectively (р>0,05). The intervention was regarded as technically successful in 100% cases. The overall frequency of major cardiovascular complications during hospitalization in patients of groups 1 and 2 was 3.5 and 2.94% respectively. Long-term outcomes could be estimated in 41 patients of group 1 and 52 ones in group 2. All patients survived for 12 months. The frequency of non-fatal MI was 4.9 and 3.8% in groups 1 and 2 respectively (р>0,05), the cause being progression of atherosclerosis in other arteries. Frequency of in-stent restenosis was 2.4 and 1.9% (р>0,05). Cases of late stent thrombosis were absent whereas coherence tomography revealed severe intravascular volume depletion to 0.14±0.19 and 0.12±0,23 mm in groups 1 and 2 respectively (р>0,05). Conclusion. Bioabsorbable endoprostheses implanted to patients with coronary heart disease and type 2 diabetes mellitus and stenosis of middle and distal segments of the main coronary arteries within 12 months after surgery proved as efficient and safe as everolimus-coated stents.