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Aims: The safety and efficacy of biodegradable polymer-based drug-eluting stents remain unclear. The aim of this study was to evaluate the safety and efficacy of biodegradable polymer-based sirolimus-eluting stent (SES) in a porcine coronary model. Methods and Results: Sirolimus and biodegradable PLGA (50:50) polymer were used to coat-a diamond-like carbon-coated bare metal stent (MOMO-BMS). The sirolimus content was 100 μg/cm2 (SES100) or 140 μg/cm2 (SES140). Stents were implanted in porcine coronaries. The animals were euthanized at 1 and 3 months (n = 4 each). At 1 month, histological analysis revealed that both SES100 and SES140 had significantly higher fibrin scores than MOMO-BMS, and like MOMOBMS, they decreased to baseline level at 3 months. Furthermore, both SES100 and SES140 showed less neointima than MOMO-BMS at 1 month (0.72 ± 0.35, 0.75 ± 0.20, 1.05 ± 0.42, respectively; p = 0.34), and this was maintained at 3 months with no increase of inflammatory reaction. Conclusion: The results indicate that the novel biodegradable polymer-based SES is safe and effective.

Evaluation of safety and efficacy of biodegradable polymer-based sirolimus-eluting stent in a porcine coronary artery model