title: Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY.
abstract: BACKGROUND
  Patients with cancer have an increased risk of VTE. We compared VTE rates and bleeding complications in 1) cancer patients receiving LMWH or UFH and 2) patients with or without cancer.
  
  
  METHODS
  Acutely-ill, non-surgical patients ≥ 70 years with (n = 274) or without cancer (n = 2,965) received certoparin 3,000 UaXa o.d. or UFH 5,000 IU t.i.d. for 8-20 days.
  
  
  RESULTS
  1) Thromboembolic events in cancer patients (proximal DVT, symptomatic non-fatal PE and VTE-related death) occurred at 4.50% with certoparin and 6.03% with UFH (OR 0.73; 95% CI 0.23-2.39). Major bleeding was comparable and minor bleedings (0.75 vs. 5.67%) were nominally less frequent. 7.5% of certoparin and 12.8% of UFH treated patients experienced serious adverse events. 2) Thromboembolic event rates were comparable in patients with or without cancer (5.29 vs. 4.13%) as were bleeding complications. All cause death was increased in cancer (OR 2.68; 95%CI 1.22-5.86). 10.2% of patients with and 5.81% of those without cancer experienced serious adverse events (OR 1.85; 95% CI 1.21-2.81).
  
  
  CONCLUSIONS
  Certoparin 3,000 UaXa o.d. and 5,000 IU UFH t.i.d. were equally effective and safe with respect to bleeding complications in patients with cancer. There were no statistically significant differences in the risk of thromboembolic events in patients with or without cancer receiving adequate anticoagulation.
  
  
  BACKGROUND
  clinicaltrials.gov, NCT00451412.
authors.affiliation: Institut für Experimentelle Onkologie und Therapieforschung, Technische Universität München, Germany.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Haas
authors.forename: Sebastian M
authors.initials: SM
authors.lastname: Schellong
authors.forename: Ulrich
authors.initials: U
authors.lastname: Tebbe
authors.forename: Horst-Eberhard
authors.initials: HE
authors.lastname: Gerlach
authors.forename: Rupert
authors.initials: R
authors.lastname: Bauersachs
authors.forename: Nima
authors.initials: N
authors.lastname: Melzer
authors.forename: Claudia
authors.initials: C
authors.lastname: Abletshauser
authors.forename: Christian
authors.initials: C
authors.lastname: Sieder
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.forename: Hanno
authors.initials: H
authors.lastname: Riess
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000150:complications / Q000517:prevention & control; D006493:Heparin / Q000031:analogs & derivatives / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D009369:Neoplasms / Q000150:complications*; D018570:Risk Assessment / Q000706:statistics & numerical data; D012307:Risk Factors; D013923:Thromboembolism / Q000150:complications / Q000517:prevention & control*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D006493:Heparin; C403769:certoparin