title: Comparison of safety and efficacy between fondaparinux and nadroparin in non-ST elevation acute coronary syndromes.
abstract: BACKGROUND
  American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC) guidelines gave fondaparinux a class I recommendation for use in patients with non-ST elevation acute coronary syndromes (NSTE-ACS) undergoing invasive or conservative strategy. Nadroparin is one of the common anticoagulants used in NSTE-ACS in China. Accordingly, this study compared the safety and efficacy between fondaparinux and nadroparin in patients with NSTE-ACS.
  
  
  METHODS
  In this prospective, randomized, open-label, and single center study, a total of 300 patients with NSTE-ACS were randomized to receive either fondaparinux (group F, n = 150, 2.5 mg/d) or nadroparin (group N, n = 150, 0.1 ml/10 kg q12 h) for a mean of 4 days. The primary safety endpoint was the incidence of major or minor bleeding at 9 days that was not related to coronary artery bypass grafting (CABG). The primary efficacy endpoints included death, myocardial infarction, or recurrent ischemia at 9 days. All patients underwent a 180-day follow-up.
  
  
  RESULTS
  Baseline characteristics were well matched between the two groups. There was a non-significant 28% relative risk reduction in the primary safety endpoint in group F compared with group N (4.7% vs. 6.7%, HR 0.72, 95%CI 0.42-1.65, P = 0.38). The primary efficacy endpoint was 8.0% in group F and 10.0% in group N (HR, 0.82, 95%CI 0.54-1.71, P = 0.49). The composite of the safety and efficacy endpoints at 9 days (10.0% vs. 16.0%, HR 0.61, 95%CI 0.31-1.10, P = 0.10), 30 days (14.0% vs. 17.9%, HR 0.72, 95%CI 0.47-1.16, P = 0.21), or 180 days (18.7% vs. 27.3%, HR 0.65, 95%CI 0.38-1.11, P = 0.11) showed a non-significant trend toward a lower value in group F.
  
  
  CONCLUSIONS
  Fondaparinux resulted in a nonsignificant risk reduction in patients with NSTE-ACS in both bleeding and ischaemic events during short- and long-term follow-up compared with nadroparin.
authors.affiliation: Cardiovascular Institute and Fuwai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100037, China. yan591204@yahoo.com.cn
authors.forename: Hong-bing
authors.initials: HB
authors.lastname: Yan
authors.forename: Li
authors.initials: L
authors.lastname: Song
authors.forename: Ran
authors.initials: R
authors.lastname: Liu
authors.forename: Han-jun
authors.initials: HJ
authors.lastname: Zhao
authors.forename: Shao-pin
authors.initials: SP
authors.lastname: Wang
authors.forename: Yun-peng
authors.initials: YP
authors.lastname: Chi
authors.forename: Bin
authors.initials: B
authors.lastname: Zheng
authors.forename: Wen-zheng
authors.initials: WZ
authors.lastname: Li
authors.forename: Chen
authors.initials: C
authors.lastname: Liu
authors.forename: Peng
authors.initials: P
authors.lastname: Zhou
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000077425:Fondaparinux; D006801:Humans; D008297:Male; D008875:Middle Aged; D017762:Nadroparin / Q000009:adverse effects* / Q000627:therapeutic use*; D011134:Polysaccharides / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D005343:Fibrinolytic Agents; D017762:Nadroparin; D011134:Polysaccharides; D000077425:Fondaparinux