title: Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study.
abstract: BACKGROUND
  Renal impairment is common, affecting around 40% of acutely ill medical patients, and is associated with an increased risk of both venous thromboembolism (VTE) and bleeding. The clinical benefit of effective thromboprophylactic strategies may be outweighed in these patients by an excessive rate of hemorrhage.
  
  
  OBJECTIVE
  To assess the safety and efficacy of lower prophylactic doses of fondaparinux in acutely ill medical patients with renal impairment.
  
  
  METHODS
  We carried out a multicenter, investigator-initiated, prospective cohort study. Patients at risk of VTE with a creatinine clearance between 20 and 50 mL min(-1) were treated with fondaparinux 1.5 mg qd for a minimum of 6 to a maximum of 15 days. The primary outcome was the incidence of major bleeding; secondary outcomes were clinically relevant non-major bleeding (CRNMB) and symptomatic VTE.
  
  
  RESULTS
  We enrolled 206 patients with a mean age of 82 years, mean creatinine clearance of 33 mL min(-1) , and a mean Charlson co-morbidity index of 8.2. One patient had major bleeding (0.49%, 95% confidence interval [CI] 0.03-3.10), eight had CRNMB (3.88%, 95% CI 1.81-7.78) and three developed symptomatic VTE (1.46%, 0.38-4.55). Twenty-three patients (11.17%, 7.36-16.48) died. No independent predictors of bleeding were found at univariate analysis.
  
  
  CONCLUSIONS
  The addition of moderate to severe renal impairment to patients with traditional risk factors for VTE identified a population of very elderly acutely ill medical patients potentially at high risk of both VTE and bleeding complications. The recently approved lower prophylactic dose of fondaparinux appears to be a safe and relatively effective strategy in these patients.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese IRCCS Policlinico S. Matteo Foundation, University of Pavia, Pavia Department of Medical, Oral and Biotechnological Sciences, University 'G.D'Annunzio' of Chieti-Pescara Department of Internal Medicine, Ospedale S. Andrea, La Spezia Department of Internal Medicine, Arcispedale S. Maria Nuova, Reggio Emilia Department of Internal Medicine, Ospedale Sacro Cuore di Gesù, Gallipoli Department of Emergency Medicine, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan Department of Internal Medicine, Ospedale di Rovigo, Rovigo Department of Internal Medicine, University of Turin, Ospedale S. Giovanni, Torino Department of Emergency Medicine, Ospedale di Piacenza, Piacenza, Italy.
authors.forename: W
authors.initials: W
authors.lastname: Ageno
authors.forename: N
authors.initials: N
authors.lastname: Riva
authors.forename: P
authors.initials: P
authors.lastname: Noris
authors.forename: M
authors.initials: M
authors.lastname: Di Nisio
authors.forename: M
authors.initials: M
authors.lastname: La Regina
authors.forename: D
authors.initials: D
authors.lastname: Arioli
authors.forename: L
authors.initials: L
authors.lastname: Ria
authors.forename: V
authors.initials: V
authors.lastname: Monzani
authors.forename: S
authors.initials: S
authors.lastname: Cuppini
authors.forename: E
authors.initials: E
authors.lastname: Lupia
authors.forename: M
authors.initials: M
authors.lastname: Giorgi Pierfranceschi
authors.forename: M G
authors.initials: MG
authors.lastname: Pierfranceschi
authors.forename: F
authors.initials: F
authors.lastname: Dentali
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage*; D003404:Creatinine / Q000652:urine; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage*; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000150:complications / Q000517:prevention & control; D051437:Renal Insufficiency / Q000150:complications / Q000517:prevention & control*; D012307:Risk Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000150:complications / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000150:complications / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D003404:Creatinine; D000077425:Fondaparinux