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One-Year Clinical Outcome of a Randomized Trial of Polymer-Free Paclitaxel-Eluting Stents Versus Biodegradable Polymer-Based Rapamycin-Eluting Stents in Patients with Coronary Heart Disease.
MedLine Citation:
PMID:  22384973     Owner:  NLM     Status:  Publisher    
Background: More widespread use of drug-eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer-free and biodegradable polymer-based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear. Methods and Results: To assess whether polymer-free paclitaxel-eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end-point was major adverse cardiac events (MACE). The secondary end-points included stent thrombosis events, all-cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one-year MACE according to a noninferiority or equivalence margin of 0.1. One-year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one-sided 95% confidence interval was -0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [-0.0698, 0.0742] (P (1) = 0.004 and P (2) = 0.007 from 2 times the 1-sided test for equivalence). There was no statistically significant difference in thrombosis events, all-cause death, and rehospitalization (all P > 0.05). Conclusions: In this small randomized trial, polymer-free paclitaxel-eluting stents appear to be noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents. (J Interven Cardiol 2012;**:1-7).
Lan Zhang; Jia Yuan; Gan Liu; Jin-Peng Zhong; Yue-Hui Yin; Qiang She; Li Su; Zhi-Yu Ling; Yun-Qing Chen
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-4
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  -     ISSN:  1540-8183     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
©2012, Wiley Periodicals, Inc.
From the Department of Cardiology, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, P.R. China.
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