Mondial Assessment of Thromboembolism treatment Initiated by Synthetic pentasaccharide with Symptomatic Endpoints – Pulmonary Embolism (2003)


Treatment of acute symptomatic pulmonary embolism (PE)

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To determine whether fixed-dose fondaparinux is at least as effective as adjusted-dose UFH for the initial treatment of symptomatic PE

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Trial design

Randomized, open trial with parallel groups
Active treatment: fondaparinux 5.0, 7.5, or 10.0 mg s.c. once daily in patients weighing <50, 50–100, or >100 kg, respectively, given for at least 5 days and until the use of vitamin K antagonists resulted in an INR >2.0 (n=1103)
Control treatment: UFH 5000 IU i.v. bolus, then ≥1250 IU/h continuous i.v. infusion to target aPTT 1.5–2.5 times a control value, for ≥5 days until INR >2.0 (n=1110)

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Primary efficacy endpoint: 3-month incidence of the composite of symptomatic, recurrent PE (non-fatal or fatal) and new or recurrent DVT
Primary safety endpoints: major bleeding during the initial treatment period and death during the 3-month study period

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Trial participants

2213 patients (mean age 62.5 years) with acute symptomatic PE and who required antithrombotic therapy

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Efficacy outcome: The composite primary endpoint of recurrent thromboembolic events occurred in 42 of the 1103 patients assigned to fondaparinux (3.8%) and in 56 of the 1110 patients receiving UFH (5.0%)
Safety outcome: Major bleeding during initial treatment occurred in 1.3% of the patients in the fondaparinux group and in 1.1% of the UFH group. Mortality rates at 3 months were similar in the 2 groups (5.2 % with fondaparinux vs. 4.4% with UFH)

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Efficacy: Once-daily unmonitored subcutaneous administration of fondaparinux is at least as effective as adjusted-dose intravenous administration of UFH in the initial treatment of hemodynamically stable patients with PE
Safety: The incidence of major bleeding was similar with fondaparinux and UFH

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Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003;349:1695-1702

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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, e-mail:

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