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


CONCLUSIONS
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.
Sahajanand Medical Technologies Pvt. Ltd., 'Sahajanand Estate', Vakharia Wadi, Surat - 395004, India.
Ashok S
AS
Thakkar
Atul D
AD
Abhyankar
Sameer I
SI
Dani
Darshan N
DN
Banker
Parvinder I
PI
Singh
Sanjay A
SA
Parmar
Anita A
AA
Mehta
D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000378:metabolism* / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics*; D007194:India; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000493:pharmacokinetics*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus