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
Article first published online: 30 OCT 2012
© 2012 International Society on Thrombosis and Haemostasis
Journal of Thrombosis and Haemostasis
Volume 10, Issue 11, pages 2291–2297, November 2012
How to Cite
AGENO, W., RIVA, N., NORIS, P., DI NISIO, M., LA REGINA, M., ARIOLI, D., RIA, L., MONZANI, V., CUPPINI, S., LUPIA, E., PIERFRANCESCHI, M. G., DENTALI, F. and for the FONDAIR study group (2012), 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. Journal of Thrombosis and Haemostasis, 10: 2291–2297. doi: 10.1111/j.1538-7836.2012.04908.x
- Issue published online: 30 OCT 2012
- Article first published online: 30 OCT 2012
- Accepted manuscript online: 24 AUG 2012 09:41AM EST
- Received 15 June 2012, accepted 18 August 2012
- renal failure;
- venous thromboembolism
Summary. 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 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.