title: Safety and efficacy of the CYPHER Select Sirolimus-eluting stent in the "Real World"--clinical and angiographic results from the China CYPHER Select registry.
abstract: OBJECTIVE
  This post-marketing surveillance registry is aimed at determining the safety and reliability of the CYPHER Select Sirolimus-eluting stent (SES) in routine clinical practice.
  
  
  BACKGROUND
  Little information and angiographic follow-up data in large-scale "real world" registry is available for the CYPHER Select SES, an advanced-generation SES.
  
  
  METHODS
  This was a prospective multicenter (20 centers) registry. 1189 consecutive patients who received at least 1 CYPHER Select SES during daily clinical practice were enrolled. Patients who underwent emergency stenting for acute myocardial infarction were excluded.
  
  
  RESULTS
  The procedure's success rate was 98.3% for CYPHER Select SES implantation, and follow-up rates were 98% with 100% data auditing. Target lesion revascularization (TLR) at 12 months occurred in 60 (5.14%) cases, cardiac death in 13 cases (1.11%), Q wave myocardial infarction (MI) in 5 cases (0.43%), non-Q-MI in 9 cases (0.77%), target vessel revascularization (TVR) in 67 cases (5.74%), and MACE defined as cardiac death, nonfatal MI and TLR in 76 cases (6.51%). MACE-free survival rate at 12 months was 93.7%. Angiographic follow-up at 9 months was performed in 418 (68.3%) lesions treated by CYPHER Select SES. The binary restenosis rate was 4.8% in-stent and 9.6% in-segment. Subgroup analysis showed diabetes, bifurcation lesion and combined use of different stents were independent risk factors of cumulative MACE. In-segment MLD </=2.25 mm at post-procedure and ostial lesion was independent predictors of in-segment restenosis.
  
  
  CONCLUSIONS
  In this registry, the MACE, TLR, angiographic late loss and binary restenosis rates of CYPHER Select SES were similar to those reported in SES randomized trials and "real world" registries. The safety and efficacy of CYPHER Select SES shown in this registry are consistent with those seen in SES studies.
authors: Chinese Society of Cardiology, China.
authors: Run-Lin
authors: RL
authors: Gao
authors: Bo
authors: B
authors: Xu
authors: Shu-Zheng
authors: SZ
authors: Lu
authors: Ji-Lin
authors: JL
authors: Chen
authors: Ya-Ling
authors: YL
authors: Han
authors: Jun-Zhu
authors: JZ
authors: Chen
authors: Lu-Yue
authors: LY
authors: Gai
authors: Jun-Bo
authors: JB
authors: Ge
authors: Wei-Min
authors: WM
authors: Wang
authors: Zhi-Min
authors: ZM
authors: Du
authors: Yong
authors: Y
authors: Huo
authors: Le-Feng
authors: LF
authors: Wang
authors: Wei
authors: W
authors: Gao
authors: Ji-Yan
authors: JY
authors: Chen
authors: Ben
authors: B
authors: He
authors: Guo-Liang
authors: GL
authors: Jia
authors: Zhi-Jian
authors: ZJ
authors: Yang
authors: Ke-Jiang
authors: KJ
authors: Cao
authors: Wei-Min
authors: WM
authors: Li
authors: Wei-Feng
authors: WF
authors: Shen
authors: Zheng
authors: Z
authors: Wan
authors: De-Jia
authors: DJ
authors: Huang
authors: Guo-Ying
authors: GY
authors: Zhu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China / Q000453:epidemiology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000453:epidemiology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D003331:Coronary Vessels / Q000473:pathology; D003920:Diabetes Mellitus / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus