RESULTS OF BIODEGRADABLE VASCULAR ENDOPROSTHESES IMPLANTATION IN ISCHEMIC HEART DISEASE PATIENTS WITH TYPE 2 DIABETES

Aim. To evaluate efficacy of endovascular treatment in patients with diabetes, operated with biodegradable vascular endoprostheses and everolimus eluting stents.

Material and methods. Primarily, 143 patients were selected into the study. Then 125 patients included and randomized to 2 groups. Patients of I group (n=57) underwent implantation biodegradable vascular endoprostheses, and the II group (n=68) — coronary stents eluting everolimus. For the control of biodegradable endoprostheses implantation optical coherent tomography was used, that was performed at the end of intervention and in long-term follow-up by 12 months. Results. Totally, 63 biodegradable vascular endoprostheses implanted to the patients of I group, and 102 everolimus coated stents to II group patients. Mean diameter of implanted endoprostheses in group I was — 2,88±0,06 mm, and in group II — 2,68±0,12 mm (р>0,05). Technical success of intervention was 100% in both groups. Total number of serious cardiovascular complications during in-patient phase was 3,5% and 2,94% in groups, respectively (p>0,05). Long-term results were followed-up in 41 patient from group I and in 52 from group II. In 12 months survival rate was 100%. Prevalence of non-fatal MI among I and II group patients was 4,9% and 3,8%, resp. (p>0,05). The reason was progression of atherosclerotic process in other arteries. Restenosis prevalence that required new intervention on target lesion was 2,4% and 1,9%, resp. (p>0,05). Late thrombosis in long-term follow-up was not marked in both groups. Late loss of intrinsic lumen of the vessel, by the data of optical coherent tomography was 0,14±0,19 mm and 0,12±0,23 mm, respectively, for groups I and II (р>0,05).

Conclusion. Biodegradable vascular endoprostheses in CHD patients with diabetes and mostly involvement of middle and distal segments of coronary arteries, showed equal efficacy and safety, with everolimus coated stents, in 12 months after intervention.

1. Serruys PW, Kutryk MJV. Coronary artery stents. N. Engl.J.Med. 2006; 354: 483-95. doi:10.1056/NEJMra051091.

2. Doron A, Edelman ER. Revascularization for coronary artery disease in diabetes mellitus: Angioplasty, stents and coronary artery bypass grafting. Rev. Endocr. Metab. Disord. 2010; 11(11): 75-86.

3. Stettler C, Allemann S, Wandel S. Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis. BMJ. 2008; 337: a1331-a1334.

4. Stone GW, Kedhi E, Kereiakes DJ, et al. Differential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus. Circulation. 2011; 124: 893-900. doi.org/10.1161/CIRCULATIONAHA.111.031070.

5. Shustov SB, Krjukov NN, Nikolaevskij EN, et al. Atherosclerosis in diabetes mellitus. Coronary heart disease: modern aspects of clinic, diagnostics, treatment, prevention, medical rehabilitation, examination. Samara; 2010: 75-8. Russian (Шустов C. Б., Крюков Н. Н., Николаевский E. Н. и др. Атеросклероз при сахарном диабете. Ишемическая болезнь сердца: современные аспекты клиники, диагностики, лечения, профилактики, медицинской реабилитации, экспертизы. Самара; 2010: 75-8).

6. Kedhi E, Genereux P, Palmerini T, et al. Impact of Coronary Lesion Complexity on Drug-Eluting Stent Outcomes in Patients With and Without Diabetes Mellitus Analysis From 18 Pooled Randomized Trials. J Am Coll Cardiol. 2014; 63: 2111-8.

7. Depukat R, Dudek D. Biodegradable stents — 4th revolution of the interventional cardiology. Postep Kardiollnter. 2009; 5: 144-7.

8. Onuma Y Serruys PW, Perkins LE, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation. 2010; 122: 2288-300.

9. Dudek D, Onuma Y Ormiston JA, et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. Eurointervention. 2012; 7: 1060-1.

10. Nieman K, Dudek D, Ormiston J, et al. ABSORB cohort a trial: five year clinical and MSCT results of the ABSORB bioresorbable everolimus eluting vascular scaffold. Circulation. 2011; 124: A10570.

11. Serruys PW, Ormiston JA, Onuma Y et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373: 897-910.

12. Gomez-Lara J, Diletti R, Brugaletta S, et al. Angiographic maximal luminal diameter and appropriate deployment of the everolimus eluting bioresorbable vascular scaffold as assessed by optical coherence tomography. Eurointervention. 2012; 8: 214-24.

13. Farooq V, Gomez-Lara J, Brugaletta S, et al. Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheter Cardiovasc Interv. 2012; 79: 880-8.