5 years clinic trial result of a stent with time sequence functions
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1
Southwest Jiaotong University, Key Lab. of Advanced Technology of Materials, Ministry of Education, China
Introduction: The application of cardiovascular stent have saved millians of patient‘s life. Drug eluting stent (DES) is present leading interventional device for treating coronary artery disease. which has shown a very effective solution for suppressing restenosis, but unfortunatly it increases late thrombus rate which is even more dangerous because of over 50% of death rate. This presentation reports 5 years clinic trial result of the author’s group developed stent which was designed for improving both anticoagulation and anti-restenosis. And the 2 years result of clinic application is also presented.
Materials and Methods: A stent consists of metal stent/titanium oxide film/drug eluting coating (biodegradable polymer PLGA containing of rapamycin) developed by author’s lab. was transfered to a company, and the clinic trail was performed since 2009, a commercialrized Chinese drug eluting stent was chosen as compairsion. Totally 299 patients in the clinic trial were chosed and the testing and comparsion groups were 148 and 151 persons respectivly.
Results and Discussion: Clinic trial date showed that restenosis rate of both testing and comparison stent for 270 days was 1.1% and 1.8% respectively, there was no significant difference. No late thombus was found during the 5 years clinic trial for testing group, however the late thombus rate of comparing stent was 2.1% during one year, and after 5 years the late thrombus formed patients was increased as 3.9%, and 77% patients among them were die. Forthermore there was no late thombus was reported when the complx coating stent applied on 9070 patients during 2 years after the approval of the stent for clinic application was obtained.
Based on the research in vitro and clinic practice, the authors proposed that the developed stent posses the ability to perfom the “time sequence function”. Which means that a good stent should always play a positive role in the evolotion of the interaction between the stent and the host enviroment. At the acute stage the drug release plays the role to supress restenosis, and then the drug carrier PLGA is degraded and the Ti-O film surface is exposed to blood which posses excellent antithrombotic properties and supports the endothelialization. In the longterm stage the Ti-O film coating on the metal stent prevents the release of deleterious elements from the stent into the surrounding tissue and increases the long-term biocompatibility. The “time sequence function” may be very meanningfull comception for stent development.
Conclusions: a stent consists of metal stnet/Ti-O film/drug eluting coating showed excellent anticoagulation as well as antirestenosis ability. It could attribute to that the stent was posses the ability of “time sequence functions”.
This work was supported by NSFC project 81330031, 81271701 and Key Basic Research program 2011CB606204
Keywords:
clinical application,
material design,
surface property,
device
Conference:
10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016.
Presentation Type:
General Session Oral
Topic:
Clinical performance of implantable stents
Citation:
Huang
N,
Leng
Y,
Wang
J,
Yang
P,
Chen
J,
Wan
G,
Sun
H and
You
T
(2016). 5 years clinic trial result of a stent with time sequence functions.
Front. Bioeng. Biotechnol.
Conference Abstract:
10th World Biomaterials Congress.
doi: 10.3389/conf.FBIOE.2016.01.01412
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Received:
27 Mar 2016;
Published Online:
30 Mar 2016.
*
Correspondence:
Dr. Ping Yang, Southwest Jiaotong University, Key Lab. of Advanced Technology of Materials, Ministry of Education, Chengdu, China, yangping8@263.net