Safety and efficacy of low-dose fondaparinux (1.5mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: The FONDAIR study

W. Ageno, N. Riva, P. Noris, M. Di Nisio, M. La Regina, D. Arioli, L. Ria, V. Monzani, S. Cuppini, E. Lupia, M. G. Pierfranceschi, F. Dentali, Walter Ageno, Alessandro Squizzato, Davide Imberti, Mario Pini, Marcello Di Nisio, Mauro Silingardi, Giancarlo Agnelli, Walter AgenoNicoletta Riva, Raffaella Cavi, Nicoletta Riva, Marco Moia, Franco Piovella, Gualtiero Palareti

Research output: Contribution to journalArticlepeer-review

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. Patients/Methods: We carried out a multicenter, investigator-initiated, prospective cohort study. Patients at risk of VTE with a creatinine clearance between 20 and 50mLmin-1were treated with fondaparinux 1.5mg qd for a minimum of 6 to a maximum of 15days. 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 82years, mean creatinine clearance of 33mLmin-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.

Original languageEnglish
Pages (from-to)2291-2297
Number of pages7
JournalJournal of Thrombosis and Haemostasis
Volume10
Issue number11
DOIs
Publication statusPublished - 2012

Keywords

  • Prophylaxis
  • Renal failure
  • Venous thromboembolism

ASJC Scopus subject areas

  • Hematology

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