Mondial Assessment of Thromboembolism treatment Initiated by Synthetic pentasaccharide with Symptomatic Endpoints – Deep Vein Thrombosis (2004)


Initial treatment of symptomatic DVT

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To evaluate the efficacy and safety of fondaparinux compared with enox-aparin in the initial treatment of symptomatic DVT

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Trial design

Randomized, double-blind placebo-controlled study
Active treatment: fondaparinux 7.5 mg (5.0 mg in patients weighing <50 kg and 10.0 mg in patients weighing >100 kg) s.c. once daily for at least 5 days and until the use of vitamin K antagonists resulted in an INR >2.0; enoxaparin placebo (n=1098)
Control treatment: enoxaparin 1 mg/kg s.c. twice daily for at least 5 days and until vitamin K antagonists induced an INR >2.0; fondaparinux placebo (n=1107)

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Primary efficacy endpoint: 3-month incidence of symptomatic recurrent VTE complications (DVT and PE)
Primary safety endpoints: major bleeding during the initial treatment period and 3-months mortality

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Trial participants

2205 patients (mean age 61 years) with acute symptomatic DVT and who required antithrombotic therapy

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Efficacy outcome: The composite primary endpoint of recurrent thromboembolic events at 3 months occurred in 43 of the 1098 patients receiving fondaparinux (3.9%) and in 45 of the 1107 patients assigned to enoxaparin (4.1%)
Safety outcome: The incidence of major bleeding during initial treatment was 1.1% in the fondaparinux group and in 1.2% in the enoxaparin group. At 3 months, 3.8% of the patients given fondaparinux and 3.0% of the patients given enoxaparin had died

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Efficacy: Once-daily administration of fondaparinux was not inferior to twice daily administration of enoxaparin for initially treating symptomatic DVT
Safety: The incidence of major bleeding was similar with fondaparinux and enoxaparin

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Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, Segers AE, Cariou R, Leeuwenkamp O, Lensing AW, for the Matisse Investigators. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med 2004;140:867-873

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Corresponding author

Harry R. Büller, MD, Academic Medical Center, Department of Vascular Medicine, F4-211, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands

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