title: Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry.
abstract: BACKGROUND
  Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.
  
  
  METHODS
  The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.
  
  
  RESULTS
  Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 ± 0.40) mm in-segment and (0.23 ± 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.
  
  
  CONCLUSIONS
  The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)
authors.affiliation: Department of Cardiology, Xijing Hospital Affiliated to Fourth Military Medical University, Xi'an, Shaanxi 710032, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Cheng-xiang
authors.initials: CX
authors.lastname: Li
authors.forename: Hai-chang
authors.initials: HC
authors.lastname: Wang
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Wei-yi
authors.initials: WY
authors.lastname: Fang
authors.forename: Jun-bo
authors.initials: JB
authors.lastname: Ge
authors.forename: Wei-min
authors.initials: WM
authors.lastname: Wang
authors.forename: Shu-bin
authors.initials: SB
authors.lastname: Qiao
authors.forename: Jack-P
authors.initials: JP
authors.lastname: Chen
authors.forename: Wen-kuang
authors.initials: WK
authors.lastname: Shen
authors.forename: Hong
authors.initials: H
authors.lastname: Jiang
authors.forename: Hong-liang
authors.initials: HL
authors.lastname: Cong
authors.forename: Xiao-qun
authors.initials: XQ
authors.lastname: Pu
authors.forename: Yong-wen
authors.initials: YW
authors.lastname: Qin
authors.forename: Hui-gen
authors.initials: HG
authors.lastname: Jin
authors.forename: Yu
authors.initials: Y
authors.lastname: Cao
authors.forename: He
authors.initials: H
authors.lastname: Huang
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods*; D044466:Asian People; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus