PMID- 25944843 OWN - NLM STAT- MEDLINE DCOM- 20160926 LR - 20220331 IS - 1940-4034 (Electronic) IS - 1074-2484 (Linking) VI - 21 IP - 1 DP - 2016 Jan TI - A Nuclear Magnetic Resonance Spectroscopy as a Method for Evaluation of In Vivo Poly-l-Lactide Biodegradation Kinetics From Stent-Polymer Matrices: An Experimental Study Utilizing Porcine Model of In-Stent Restenosis. PG - 93-9 LID - 10.1177/1074248415583091 [doi] AB - OBJECTIVES: We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method. METHODS: In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures. Vessel segments with BPS were harvested to evaluate polymer degradation with a NMR method, whereas BP-SES to analyze sirolimus tissue uptake and retention. Additionally, 8 BP-SES were implanted for histological analysis for 90 days of follow-up. RESULTS: The NMR showed a gradual absorption of the polymer over the 6 consecutive time points, from 5.48 microg of the polymer on the stent at 1-day follow-up, through 4.33 microg at 3 days, 3.16 microg at 7 days, 2.42 microg at 14 days, 1.92 microg at 28 days to 1.24 microg in the last day of the study. The curve of polymer degradation corresponds well with the pharmacokinetic profile of sirolimus eluted from its surface and measured at identical time points. In histopathology, at 90 days, complete healing and biocompatibility were reported. CONCLUSIONS: The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution. CI - (c) The Author(s) 2015. FAU - Orlik, Bartlomiej AU - Orlik B AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Buszman, Piotr P AU - Buszman PP AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland Third Clinical Department of Cardiology, Silesian Center for Heart Diseases, Zabrze, Poland. FAU - Krauze, Agata AU - Krauze A AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Gasior, Pawel AU - Gasior P AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Desperak, Piotr AU - Desperak P AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Pajak, Jacek AU - Pajak J AD - Department of Histopathology, Medical University of Silesia, Katowice, Poland. FAU - Kasperczyk, Janusz AU - Kasperczyk J AD - Center of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland. FAU - Janas, Adam AU - Janas A AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Jelonek, Michal AU - Jelonek M AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Handzlik-Orlik, Gabriela AU - Handzlik-Orlik G AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Buszman, Pawel E AU - Buszman PE AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. FAU - Milewski, Krzysztof AU - Milewski K AD - Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland k.milewski@ahp-ccrd.org. LA - eng PT - Evaluation Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20150505 PL - United States TA - J Cardiovasc Pharmacol Ther JT - Journal of cardiovascular pharmacology and therapeutics JID - 9602617 RN - 0 (Cardiovascular Agents) RN - 0 (Polyesters) RN - 459TN2L5F5 (poly(lactide)) RN - W36ZG6FT64 (Sirolimus) SB - IM MH - *Absorbable Implants MH - Animals MH - Cardiovascular Agents/administration & dosage/*pharmacokinetics MH - Coronary Restenosis/*therapy MH - Disease Models, Animal MH - *Drug-Eluting Stents MH - Female MH - *Magnetic Resonance Spectroscopy MH - Male MH - Percutaneous Coronary Intervention/*instrumentation MH - Polyesters/*chemistry MH - Prosthesis Design MH - Sirolimus/administration & dosage/*metabolism/pharmacokinetics MH - Sus scrofa OTO - NOTNLM OT - NMR spectroscopy OT - biodegradable polymer OT - coronary stents OT - porcine model OT - sirolimus-eluting stent EDAT- 2015/05/07 06:00 MHDA- 2016/09/27 06:00 CRDT- 2015/05/07 06:00 PHST- 2014/11/11 00:00 [received] PHST- 2015/03/02 00:00 [accepted] PHST- 2015/05/07 06:00 [entrez] PHST- 2015/05/07 06:00 [pubmed] PHST- 2016/09/27 06:00 [medline] AID - 1074248415583091 [pii] AID - 10.1177/1074248415583091 [doi] PST - ppublish SO - J Cardiovasc Pharmacol Ther. 2016 Jan;21(1):93-9. doi: 10.1177/1074248415583091. Epub 2015 May 5.