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Gerald Simonneau, MD; Bernard Charbonnier, MD; Herve Decousus, MD; Bernard Planchon, MD; Jacques Ninet, MD; Pierre Sie, MD; Marc Silsiguen, MD; Sophie Combe, MD

Arch Intern Med. 1993;153(13):1541-1546.

Abstract
Background
A low-molecular-weight heparin, enoxaparin sodium, has been shown to be effective and safe in preventing deep vein thrombosis both in general surgery and in high-risk orthopedic surgery. We conducted a controlled, randomized trial with enoxaparin in the treatment of established deep vein thrombosis.

Methods
In a multicenter trial, we compared fixed-dose subcutaneous enoxaparin, given twice daily, with adjusteddose intravenous unfractionated heparin (UFH) given by continuous intravenous infusion for the initial 10 days of treatment of patients with proximal vein thrombosis. The primary efficacy outcome was the change of the size of the thrombus assessed by repeated venograms between day 0 and day 10. The primary analysis of safety was based on the incidence of major bleeding during 10 days of treatment.

Results
There were 67 patients in each group. Venographic assessment of clot size evolution between day 0 and day 10 showed a statistically significant superiority (P<.002) of enoxaparin over the reference treatment with UFH. Moreover, the incidence of overall recurrent thromboembolic events during 10 days of treatment was significantly higher (P<.002) in the UFH group (seven of 67) than in the enoxaparin group (one of 67). There were no serious bleeding complications in either group.

Conclusions
Enoxaparin is at least as effective and safe as UFH under the conditions of this study. Moreover, it is more comfortable for patients and less time-consuming for nurses and laboratories. Thus, our study confirmed, with the use of enoxaparin, other observations that lowmolecular-weight heparin provides a real therapeutic advance in the treatment of deep vein thrombosis.

(Arch Intern Med. 1993;153:1541-1546)

Author Affiliations
From the Department of Pneumology and Intensive Care Medicine, Antoine Béclère Hospital, Clamart, France (Dr Simonneau); The Division of Cardiology, Trousseau Hospital, Tours, France (Dr Charbonnier); the Division of Medicine, Bellevue Hospital, Saint-Etienne, France (Dr Decousus); the Division of Medicine, Hôtel-Dieu Hospital, Nantes, France (Dr Planchon); the Division of Medicine, Edouard Herriot Hospital, Lyons, France (Dr Ninet); the Department of Hematology, Purpan Hospital, Toulouse, France (Dr Sie); and Pharmuka Laboratories, Neuilly-Sur-Seine, France (Drs Silsiguen and Combe).

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