Fondaparinux for the treatment of superficial-vein thrombosis in the legs.
BACKGROUND
The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established.


METHODS
In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47. The main safety outcome was major bleeding. The patients were followed until day 77.


RESULTS
The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo.


CONCLUSIONS
Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.)
Decousus
Hervé
H
INSERM CIE3, F-42055, EA3065 Université Jean-Monnet, and Service de Médecine et Thérapeutique, Centre Hôpitalier Universitaire Saint-Etienne, Hôpital Nord, Saint-Etienne, France. herve.decousus@chu-st-etienne.fr
Prandoni
Paolo
P
Mismetti
Patrick
P
Bauersachs
Rupert M
RM
Boda
Zoltán
Z
Brenner
Benjamin
B
Laporte
Silvy
S
Matyas
Lajos
L
Middeldorp
Saskia
S
Sokurenko
German
G
Leizorovicz
Alain
A
D000208:Acute Disease; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011655:Pulmonary Embolism / Q000453:epidemiology / Q000517:prevention & control; D012008:Recurrence; D012306:Risk; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery
D000925:Anticoagulants; D011134:Polysaccharides; D000077425:Fondaparinux