TY - JOUR
T1 - Fondaparinux for the treatment of superficial-vein thrombosis in the legs
AU - Decousus, Hervé
AU - Prandoni, Paolo
AU - Mismetti, Patrick
AU - Bauersachs, Rupert M.
AU - Boda, Zoltán
AU - Brenner, Benjamin
AU - Laporte, Silvy
AU - Matyas, Lajos
AU - Middeldorp, Saskia
AU - Sokurenko, German
AU - Leizorovicz, Alain
AU - AUTHOR GROUP
AU - Décousus, H.
AU - Leizorovicz, A.
AU - Bauersachs, R.
AU - Brenner, B.
AU - Laporte, S.
AU - Mismetti, P.
AU - Prandoni, P.
AU - Richard-Lordereau, I.
AU - Boda, Z.
AU - Matyas, L.
AU - Sokurenko, G.
AU - Schulman, S.
AU - Cucherat, M.
AU - Ford, I.
AU - Monreal, M.
AU - Becker, F.
AU - Bost, V.
AU - Girard, P.
AU - Constans, J.
AU - Gauthier, E.
AU - Seymour, L.
AU - Froloshki, B.
AU - Stober, P.
AU - Borthwick, L.
AU - Jaques, D.
AU - Trelfa, A.
AU - Allende-Echevarrietta, P.
AU - Kensit, S.
AU - Kovacs, I.
AU - Laursen, E.
AU - Dramov, A.
AU - Chlumsky, J.
AU - Maasalu, K.
AU - Quere, I.
AU - Kiskinis, D.
AU - Hoffman, R.
AU - Piovella, F.
AU - Kamphuisen, P.
AU - Gerdes, V.
PY - 2010
Y1 - 2010
N2 - 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. 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. 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. 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.)
AB - 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. 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. 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. 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.)
U2 - https://doi.org/10.1056/NEJMoa0912072
DO - https://doi.org/10.1056/NEJMoa0912072
M3 - Article
C2 - 20860504
SN - 0028-4793
VL - 363
SP - 1222
EP - 1232
JO - New England journal of medicine
JF - New England journal of medicine
IS - 13
ER -