Silk Fibroin as a Coating Polymer for Sirolimus-Eluting Magnesium Alloy Stents.

Abstract

Magnesium (Mg) alloy-based, bioresorbable scaffolding is a promising candidate for next-generation stents. Rapid corrosion of Mg alloy in the physiological environment, however, hinders its clinical application. Hydrofluoric acid (HF) treatment and biodegradable polymer coating have been widely reported to enhance corrosion resistance of the Mg alloy. Poor biocompatibility of biodegradable polymers, however, is known to promote adverse events such as intimal hyperplasia and thrombosis. We selected silk fibroin (SF) as the polymer for stent coating and evaluated drug release from the SF layer, corrosion resistance of the Mg alloy, and biocompatibility. After the stent was coated with SF, ethanol treatment of the SF layer enriched the β-sheet content. Release of sirolimus (SRL), a drug that prevents intimal hyperplasia, from the SF layer was slower than that with a poly(ε-caprolactone), the conventional biodegradable polymer used on medical devices. Ethanol treatment of the SF-coated stent further slowed SRL release from the SF layer. Crystalline domains in SF formed by the β-sheet structure could contribute to the slow release of SRL. The SF coating suppressed local and deep corrosion of the Mg alloy stent, although total corrosion remained unaffected. Uniform corrosion without local or deep corrosion prolongs the stent's radial strength. The SF coating showed excellent biocompatibility with human umbilical vein endothelial cells and minimal platelet adhesion. SF is expected to replace traditional biodegradable polymers for use on bioresorbable stents.