Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core® pharmacokinetic study.

OBJECTIVES: This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting coronary stents. METHODS: Twenty patients with coronary artery disease (CAD) were treated with 1, 2, or 3 a newly designed metallic stents. Blood samples were drawn at 14 time points to determine the pharmacokinetic of sirolimus. Whole blood concentrations of sirolimus were determined by using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. RESULTS: Minimal measurable blood levels were detectable at 7 days. Across all dose levels, individual T(max) values ranged from 1.00 hour and 12.00 hours; individual C(max) ranged from 0.73 ng/mL and 4.13 ng/mL. CONCLUSION: This study confirms the limited exposure of the systemic circulation of the eluted drug with the use of the Supralimus-Core® Sirolimus-Eluting Coronary Stent System (Sahajanand Medical Technologies Pvt. Ltd., Surat, India). In this study, sirolimus concentration in systemic circulation is to be safe, well-tolerated and short-lived.