Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial

Abstract

Objective To determine the efficacy and safety of the anticoagulant fondaparinux in older acute medical inpatients at moderate to high risk of venous thromboembolism. Design Double blind randomised placebo controlled trial. Setting 35 centres in eight countries. Participants 849 medical patients aged 60 or more admitted to hospital for congestive heart failure, acute respiratory illness in the presence of chronic lung disease, or acute infectious or inflammatory disease and expected to remain in bed for at least four days. Interventions 2.5 mg fondaparinux or placebo subcutaneously once daily for six to 14 days. Outcome measure The primary efficacy outcome was venous thromboembolism detected by routine bilateral venography along with symptomatic venous thromboembolism up to day 15. Secondary outcomes were bleeding and death. Patients were followed up at one month. Results 425 patients in the fondaparinux group and 414 patients in the placebo group were evaluable for safety analysis (10 were not treated). 644 patients (75.9%) were available for the primary efficacy analysis. Venous thrombembolism was detected in 5.6% (18/321) of patients treated with fondaparinux and 10.5% (34/323) of patients given placebo, a relative risk reduction of 46.7% (95% confidence interval 7.7% to 69.3%). Symptomatic venous thromboembolism occurred in five patients in the placebo group and none in the fondaparinux group (P = 0.029). Major bleeding occurred in one patient (0.2%) in each group. At the end of follow-up, 14 patients in the fondaparinux group (3.3%) and 25 in the placebo group (6.0%) had died. Conclusion Fondaparinux is effective in the prevention of asymptomatic and symptomatic venous thromboembolic events in older acute medical patients. The frequency of major bleeding was similar for both fondaparinux and placebo treated patients.

Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs

“…1), supporting the adequacy of the prophylactic dose of 2.5 mg of fondaparinux and in accord with the substantial efficacy data already available with respect to a dose of 2.5 mg of fondaparinux in various clinical settings. [20][21][22][23] We chose a 45-day duration of treatment with the specific objective of avoiding the "catch-up" phenomenon observed with shorter (up to 30-day) courses of low-molecular-weight heparin. 6,17 This objective was met, since the efficacy of fondaparinux efficacy was maintained through day 77.…”

Prevention of venous thromboembolism in the Enhanced Recovery After Surgery (ERAS) setting: an evidence-based review

“…For surgical patients, evidence for DOAC use is limited to hip and knee arthroplasty. Fondaparinux has been studied in medical 25 and surgical patients, both orthopedic [26][27][28][29] and nonorthopedic. 30 It is an injectable direct Xa inhibitor which, while chemically similar to LMWH, does not cross-react with or cause HIT antibodies and has been used for treatment of HIT.…”

Nouveaux anticoagulants. Mise au point et enjeux en chirurgie orale

“…Ces pentasaccharides qui ont une élimination urinaire sous une forme inchangée, n'induisent pas de thrombopénie [7]. Le fondaparinux a reçu une AMM pour les indications suivantes : la pré-vention primaire des MTEV en chirurgie orthopédique (prothèse totale de genou -PTG -et prothèse totale de hanche -PTH - [8]) le traitement des MTEV (étude Matisse) [9], la prévention primaire des MTEV chez les patients médicaux hospitalisés (étude Artémis) [10] et le traitement aigu de l'angor instable ou de l'IDM avec et sans sus-décalage du segment ST (étude Oasis-6) [11], dernière extension récente de son AMM.…”