Literature DB >> 22664810

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

Ashok S Thakkar1, Atul D Abhyankar, Sameer I Dani, Darshan N Banker, Parvinder I Singh, Sanjay A Parmar, Anita A Mehta.   

Abstract

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.
Copyright © 2012 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

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Year:  2012        PMID: 22664810      PMCID: PMC3860837          DOI: 10.1016/S0019-4832(12)60086-8

Source DB:  PubMed          Journal:  Indian Heart J        ISSN: 0019-4832


  15 in total

Review 1.  In-stent stenosis: pathology and implications for the development of drug eluting stents.

Authors:  Martin R Bennett
Journal:  Heart       Date:  2003-02       Impact factor: 5.994

2.  Rapamycin (AY-22,989), a new antifungal antibiotic. I. Taxonomy of the producing streptomycete and isolation of the active principle.

Authors:  C Vézina; A Kudelski; S N Sehgal
Journal:  J Antibiot (Tokyo)       Date:  1975-10       Impact factor: 2.649

3.  Pharmacokinetics of sirolimus in stable renal transplant patients after multiple oral dose administration.

Authors:  J J Zimmerman; B D Kahan
Journal:  J Clin Pharmacol       Date:  1997-05       Impact factor: 3.126

4.  Arterial paclitaxel distribution and deposition.

Authors:  C J Creel; M A Lovich; E R Edelman
Journal:  Circ Res       Date:  2000-04-28       Impact factor: 17.367

5.  Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model.

Authors:  T Suzuki; G Kopia; S Hayashi ; L R Bailey; G Llanos; R Wilensky; B D Klugherz; G Papandreou; P Narayan; M B Leon; A C Yeung; F Tio; P S Tsao; R Falotico; A J Carter
Journal:  Circulation       Date:  2001-09-04       Impact factor: 29.690

6.  Kinetics and dynamics of single oral doses of sirolimus in sixteen renal transplant recipients.

Authors:  C Brattström; J Säwe; G Tydén; G Herlenius; K Claesson; J Zimmerman; C G Groth
Journal:  Ther Drug Monit       Date:  1997-08       Impact factor: 3.681

7.  Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial.

Authors:  Giora Weisz; Martin B Leon; David R Holmes; Dean J Kereiakes; Mel R Clark; Barry M Cohen; Stephen G Ellis; Patrick Coleman; Carolyn Hill; Chunxue Shi; Donald E Cutlip; Richard E Kuntz; Jeffrey W Moses
Journal:  J Am Coll Cardiol       Date:  2006-03-20       Impact factor: 24.094

8.  Twenty-eight-day efficacy and phamacokinetics of the sirolimus-eluting stent.

Authors:  Bruce D Klugherz; Gerard Llanos; Warren Lieuallen; Gregory A Kopia; George Papandreou; Pallassana Narayan; Brett Sasseen; Steven J Adelman; Robert Falotico; Robert L Wilensky
Journal:  Coron Artery Dis       Date:  2002-05       Impact factor: 1.439

9.  Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis.

Authors:  David R Holmes; Martin B Leon; Jeffrey W Moses; Jeffrey J Popma; Donald Cutlip; Peter J Fitzgerald; Charles Brown; Tim Fischell; Shing Chiu Wong; Mark Midei; David Snead; Richard E Kuntz
Journal:  Circulation       Date:  2004-02-10       Impact factor: 29.690

10.  Treatment with rapamycin and mycophenolic acid reduces arterial intimal thickening produced by mechanical injury and allows endothelial replacement.

Authors:  C R Gregory; X Huang; R E Pratt; V J Dzau; R Shorthouse; M E Billingham; R E Morris
Journal:  Transplantation       Date:  1995-03-15       Impact factor: 4.939

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  4 in total

1.  Evaluation of clinical outcomes in patients undergoing dual vessel percutaneous coronary intervention using sirolimus-eluting coronary stent system in India.

Authors:  Prakash Chandwani; Jayesh Prajapati; Sanjay Porwal; Bhavesh Khambhati; Ashok Thakkar
Journal:  J Clin Diagn Res       Date:  2015-02-01

2.  Development of hydrophobized alginate hydrogels for the vessel-simulating flow-through cell and their usage for biorelevant drug-eluting stent testing.

Authors:  Beatrice Semmling; Stefan Nagel; Katrin Sternberg; Werner Weitschies; Anne Seidlitz
Journal:  AAPS PharmSciTech       Date:  2013-08-06       Impact factor: 3.246

3.  Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study.

Authors:  Ranjan Shetty; Jayesh Prajapati; Umesh Pai; Kiran Shetty
Journal:  Scientifica (Cairo)       Date:  2016-08-14

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

Authors:  Praveen Chandra; Ajaykumar U Mahajan; Vipin D Bulani; Ashok S Thakkar
Journal:  Cardiol Res       Date:  2018-12-07
  4 in total

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