Safety and efficacy of biodegradable polymer-coated biolimus-eluting stents

Abstract

Background: Using drug eluting stents with a biodegradable polymer ensures that both the drug and coating are absorbed from the stent surface after completing their functions, which may reduce the need for prolonged antiplatelet therapy and decrease the risk of late stent thrombosis. Objectives: Our study sought to compare the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a well-established sirolimus- or paclitaxel-eluting stent (with durable polymers). Methods: We undertook a prospective, randomized, comparative study that included 145 patients with chronic stable coronary artery diseases or acute coronary syndromes. The patients were randomized for treatment with either biolimus-eluting (n = 62) or sirolimus/paclitaxel-eluting (n = 83) stents. The study endpoint was a composite of major adverse cardiac events (MACE) within 2 years. Angiographic follow-up was scheduled at the end of the study or earlier if clinically indicated. Results: At the two-year follow-up, a biodegradable polymer biolimus-eluting stent showed comparable safety and efficacy to permanent polymer DES(5[8.1%] patients in the biolimus group vs.8[9.6%] in the sirolimus/paclitaxel group, p = 0.7). The incidence of mortality, myocardial infarction, cerebrovascular accident and target lesion revascularization was similar for both stent types. Furthermore, the incidence of stent thrombosis was statistically non-significant between both the groups. Conclusion: The use of a biodegradable polymer-based DES (biolimus-eluting) demonstrated satisfactory efficacy and safety profiles with low MACE and stent thrombosis rates up to 2 years compared with other non-biodegradable polymer-based DES.

Keywords

• Revascularization
• Biodegradable polymer
• Drug-eluting stents