title: 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.
abstract: 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.
  
  
  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] (P1 =0.004 and P2 =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.
authors.affiliation: Department of Cardiology, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China.
authors.forename: Lan
authors.initials: L
authors.lastname: Zhang
authors.forename: Jia
authors.initials: J
authors.lastname: Yuan
authors.forename: Gan
authors.initials: G
authors.lastname: Liu
authors.forename: Jin-Peng
authors.initials: JP
authors.lastname: Zhong
authors.forename: Yue-Hui
authors.initials: YH
authors.lastname: Yin
authors.forename: Qiang
authors.initials: Q
authors.lastname: She
authors.forename: Li
authors.initials: L
authors.lastname: Su
authors.forename: Zhi-Yu
authors.initials: ZY
authors.lastname: Ling
authors.forename: Yun-Qing
authors.initials: YQ
authors.lastname: Chen
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010359:Patient Readmission / Q000706:statistics & numerical data; D011108:Polymers / Q000737:chemistry; D020123:Sirolimus / Q000008:administration & dosage; D013927:Thrombosis / Q000453:epidemiology
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus