title: Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I).
abstract: BACKGROUND
  The safety and efficacy of a China-made polymer-free paclitaxel-eluting microporous stent (Yinyi) at 1-year has been previously reported. However, limited evidence exists regarding the long-term performance of this novel drug-eluting stent (DES). This study investigated the 3-year efficacy and safety of the Yinyi stent in the setting of safety and efficacy registry of the Yinyi stent (SERY-I) clinical trial.
  
  
  METHODS
  Between June 2008 and August 2009, a total of 1045 patients undergoing percutaneous coronary intervention (PCI) were implanted with ≥ 1 Yinyi stents at 27 medical centers in mainland China. Thereafter, clinical follow-up was performed for a period of 3 years after enrollment. The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) including target lesion revascularization (TLR), the combined incidence of cardiac death, and non-fatal myocardial infarction; the second endpoint was the incidence of stent thrombosis.
  
  
  RESULTS
  Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) patients received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) patients had suffered cardiac death. The incidence of non-fatal myocardial infarction and TLR was 9 (0.92%) and 58 (5.92%) among the patients. Stent thrombosis occurred in 13 (1.33%) patients, and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.82%.
  
  
  CONCLUSIONS
  Given the limitations that SERY-I was a single arm, nonrandomized study and only telephone follow-up was performed without angiographic analysis, the safety and efficacy of Yinyi stent observed in this extended follow-up Registry needs further verification.
authors.affiliation: Department of Cardiology, Rui Jin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025.
authors.forename: Jinzhou
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Department of Cardiology, Rui Jin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025.
authors.forename: Qi
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, Union Hospital, Fujian Medical University, Fuzhou 350005, Fujian.
authors.forename: Lianglong
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Guizhou Provincial People's Hospital, Guiyang 550002, Guizhou.
authors.forename: Chenyun
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning.
authors.forename: Xuchen
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Department of Cardiology, Zhongshan People's Hospital of Guangdong Province, Guangdong 528400, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Department of Cardiology, Rui Jin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025.
authors.forename: Ruiyan
authors.initials: R
authors.lastname: Zhang
keywords: Microporous stent; Paclitaxel-eluting stent; Polymer-free; Stent thrombosis