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Superficial Vein Thrombosis Patients At Significant Risk Of Complications
A DGReview of :"A Pilot Randomized Double-blind Comparison of a Low-Molecular-Weight Heparin, a Nonsteroidal Anti-inflammatory Agent, and Placebo in the Treatment of Superficial Vein Thrombosis"
Archives of Internal Medicine
07/31/2003
By Elda Hauschildt
Patients with lower-limb superficial vein thrombosis could be at significant risk for deep and superficial venous thromboembolic complications, a pilot study in France indicates.
The double-blind pilot compared the efficacy of low-molecular-weight heparin, a non-steroidal anti-inflammatory drug (NSAID) and placebo over 8 to 12 days in 427 patients with documented acute symptomatic superficial vein thrombosis of the legs.
Incidence of deep vein thromboembolism by day 12 was 3.6% in the placebo group (111 patients), 0.9% in the 40-milligram subcutaneous enoxaparin group (109 patients), 1.0% in the 1.5-mg per kilogram subcutaneous enoxaparin group (102 patients) and 2.1% in the oral tenoxicam group ( 94 patients). Eleven patients were excluded from analysis when systematic duplex ultrasonography could not be done between days 8 and 12.
By day 12, the incidence of deep and superficial venous thromboembolism in the 416 patients was 30.6% in the placebo group. This compared with 8.3% in the 40-mg enoxaparin group, 6.9% in the 1.5 mg/kg group and 14.9% in the tenoxicam group.
"Overall, these preliminary results indicate that patients with superficial vein thrombosis of the lower limbs are at significant risk for deep and superficial venous thromboembolic complications," say researchers, led by Dr. Herve Decousus of Hopital Bellevue in Saint-Etienne.
They say therapy with a low-molecular-weight heparin or an oral NSAID both "tends to reduce" the incidence of deep vein thromboembolic complications and "is effective and safe" in reducing the incidence of recurrence or extension of superficial venous thrombosis.
A low-molecular-weight heparin appears to be more effective than a NSAID, they add, but "a curative dosage regimen of a low-molecular-weight heparin does not seem to bring additional benefit over a preventive dosage regimen."
The investigators recommend further investigations in larger patient populations to confirm their results and to examine whether a longer duration of anti-thrombotic treatment would reduce the incidence of deep venous thromboembolism.
Their study, conducted at 49 centres, was stopped when only 427 patients had been enrolled after 3 years. The study steering committee decided that the slow recruitment rate was not compatible with continuation.
Arch Intern Med 2003;163:14:1657-1663.
"A Pilot Randomized Double-blind Comparison of a Low-Molecular-Weight Heparin, a Nonsteroidal Anti-inflammatory Agent, and Placebo in the Treatment of Superficial Vein Thrombosis"
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