BIOLIMUS ELUTING STENT WITH A BIODEGRADABLE POLYMER COATING – REAL LIFE EXPERIENCE

BACKGROUND: Biodegradable coatings on drug-eluting stents (DES) may help to avoid adverse effects of DES such as stent thrombosis which is partly attributed to durable polymers.

OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a DES, which releases Biolimus A9 into the vessel wall while its polylactic acid polymer is resorbed by surrounding tissues, for the treatment of coronary artery stenosis across a wide range of patients treated in routine clinical practice settings.

METHODS: tertiary center prospective registry of consecutive patients undergoing DES implantation in an unselected population.

RESULTS: The registry included 622 patients (mean age 65,6 years, 379 (61%) male). 217 (35%) of patients had diabetes, 124 (20%) had STEMI, 134 (22%) NSTE acute coronary syndromes. Per patient a mean of 1.7 DES were implanted with a mean length of 19mm. Although a complex B2/C-lesions were present in 326 (52%) and instent restenotic lesions in 87 (14%) patients, the technical and the procedural success was achieved in 615 (99%). Incidence of target lesion revascularization (TLR) at 6 months was 29 (5%), the cumulative 6-month acute/sub acute definite stent thrombosis rate was 2 (0.3%), the rate of myocardial infarction was 20 (3.4%), the death rate was 9 (1.5%), cardiac death 7 (1.2%). After 6 months the cumulative event-free survival was 585 (94%). CONCLUSIONS: This registry demonstrates good safety and efficacy of the biodegradable coatings stent platform in real-world practice. Rates of TVR and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low.