Pharmacokinetic Study of Sirolimus-Eluting BioResorbable Vascular Scaffold System for Treatment of De Novo Native Coronary Lesions: A Sub-Study of MeRes-1 Trial

Abstract

Background: MeRes100 (Meril Life Sciences Pvt. Ltd., Vapi, India) is a novel sirolimus-eluting bioresorbable vascular scaffold (BRS). The purpose of this sub-study of MeRes-1 trial is to evaluate the systemic release of sirolimus from MeRes100 BRS implanted for the treatment of de novo native coronary artery lesions.

Methods: The MeRes-1 is a prospective, multicenter, first-in-human trial of sirolimus-eluting MeRes100 BRS. The pharmacokinetic sub-study was conducted at two Indian sites in 10 patients who were implanted with the MeRes100 BRS loaded with sirolimus at a dose of 1.25 g/mm². Venous blood samples were collected at pre-dose and 12-time points after implantation of the scaffold. Sirolimus concentration was successively analyzed using ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry method.

Results: A total of 12 scaffolds were implanted in 10 patients. Non-compartmental analysis demonstrated time to reach peak concentration of sirolimus between 0.5 h to 3 h after scaffold implantation. The peak concentration (C_max) was deduced to be 7.47 2.61 ng/mL, AUC was 436.45 171.24 hng/mL, and the t was observed at 98.59 33.58 h. The clearance was 0.66 0.16 L/h and lower limit of quantification was detectable at 14.1 days.

Conclusions: The MeRes-1 pharmacokinetic sub-study confirmed that MeRes100 BRS is safe and tolerable at limited systemic exposure of sirolimus.




Cardiol Res. 2018;9(6):364-369
doi: https://doi.org/10.14740/cr799

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