Walter Ageno, MD
What are the efficacy and safety of fondaparinux for reducing symptomatic venous thromboembolic complications or death in patients with acute symptomatic superficial venous thrombosis (SVT) in the leg?
Randomized placebo-controlled trial (Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis with Placebo [CALISTO] trial). ClinicalTrials.gov NCT00443053.
Blinded (patients and monitoring committee).*
171 centers throughout Europe and in Israel.
3002 patients ≥ 18 years of age (mean age 57 y, 64% women) with acute symptomatic lower-limb SVT ≥ 5 cm long, as confirmed by compression ultrasonography. Exclusion criteria included > 3 weeks between symptom onset and planned randomization; SVT associated with sclerotherapy, placement of an intravenous catheter, or catheter located ≤ 3 cm from the saphenofemoral junction; history of SVT within 3 months, deep venous thrombosis (DVT) or pulmonary embolism (PE) within 6 months, cancer treatment within 6 months, or major surgery within 3 months; use of an antithrombotic agent for > 48 hours (except aspirin, ≤ 325 mg/d) or a nonsteroidal antiinflammatory drug for > 72 hours for treatment of current SVT episode; indication for ligation of the saphenofemoral junction or stripping of varicose veins; and predisposition to bleeding.
Fondaparinux, 2.5 mg/d (n = 1502), or placebo (n = 1500), administered subcutaneously for 45 days.
A composite of all-cause mortality or symptomatic PE, DVT, extension to the saphenofemoral junction, or recurrence of SVT up to day 47. Secondary outcomes included the composite up to day 77. The primary safety outcome was major bleeding until day 47 or 4 days after administration of the last study drug, whichever was later.
98% (intention-to-treat analysis). 99.5% in safety analysis.
Fewer patients in the fondaparinux group had the composite outcome than did patients in the placebo group at days 47 and 77 (Table). Groups did not differ for major bleeding (P = 1.00).
Fondaparinux reduced a composite of symptomatic venous thromboembolic complications and death and did not increase major bleeding in patients with acute symptomatic superficial venous thrombosis in the leg.
Fondaparinux vs placebo for a composite of symptomatic venous thromboembolic complications and death† in symptomatic lower-limb superficial venous thrombosis‡
†All-cause mortality (0.1% vs 0.1%, P = 1.00 at day 47) or symptomatic pulmonary embolism (0.0% vs 0.3%, P = 0.03 at day 47), deep venous thrombosis (0.2% vs 1.2%, P < 0.001 at day 47), extension to the saphenofemoral junction (0.3% vs 3.4%, P < 0.001 at day 47), or recurrence of superficial venous thrombosis (0.3% vs 1.6%, P < 0.001 at day 47).
‡Abbreviations defined in Glossary. RRR, NNT, and CI calculated from relative risks and placebo event rates in article.
Ageno W. Fondaparinux reduced a composite of VTE complications or death in superficial leg-vein thrombosis. Ann Intern Med. ;154:JC2–3. doi: 10.7326/0003-4819-154-4-201102150-02003
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Published: Ann Intern Med. 2011;154(4):JC2-3.
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