[Outpatient treatment of deep vein thrombosis with low-molecular-weight heparins. Experience from an open, prospective study in daily practice].

BACKGROUND AND PURPOSE: Clinical studies have shown the safety and efficacy of low-molecular-weight heparin (LMWH) for initial treatment of deep vein thrombosis (DVT) in outpatients. Given the limited evidence for the application of LMWH in this indication in daily practice, the authors conducted an open, prospective study in primary care. Primary endpoint of this study was a clinical sign of recurrent thrombosis and/or pulmonary embolism 14 days after the end of DVT treatment with 1 mg/kg body weight enoxaparin twice daily. Secondary endpoint were bleeding complications during and up to 48 h after the end of enoxaparin treatment. Furthermore, risk factors were analyzed that may indicate later development of recurrent thrombosis.

PATIENTS AND METHODS: Consecutive inclusion of patients and documentation of use of enoxaparin in patients with diagnostically confirmed signs of DVT, which were eligible for outpatient treatment.

RESULTS: Between May 2004 and March 2005, 1,077 patients with DVT were recruited in 260 nationwide centers. 98.7% of thromboses were confirmed by diagnostic procedures. Recurrent thrombosis was observed in only 0.28% of patients (n = 3), and pulmonary embolism in further 0.37% (n = 4). 0.74% of the patients (n = 8) had minor (n = 7) and major (n = 1) bleeding complications with enoxaparin treatment. As expositional risk factors for the development of DVT, immobilization, acute illness, traumatic injury and postoperative state as well as long distance flights were identified.

CONCLUSION: An outpatient treatment of DVT with a twice daily application of enoxaparin appears to be effective and safe in daily practice. This result is of primary importance since it has been generated in a very heterogeneous patient population with different comorbid diseases and concomitant medication.