Proximal deep vein thrombosis

Subcutaneous low-molecular-weight heparin compared with continuous intravenous unfractionated heparin in the treatment of proximal deep-vein thrombosis¹

Enoxaparin 1 mg/kg subcutaneous every 12 hours is significantly more effective than UFH (an initial continuous infusion of 500 U/kg per 24 hours of unfractionated heparin sodium) and overall VTE recurrences during 10 days of treatment.¹

UFH: Unfractionated heparin; VTE: Venous thromboembolism; SC: Subcutaneous; DVT: Deep-vein thrombosis; od: Once daily.

Design:
A multicenter, controlled and randomized trial

Objective:
To compare fixed-dose (100 IU/kg or 1 mg/kg) subcutaneous enoxaparin, given twice daily, with adjusted-dose unfractionated heparin (UFH) given by continuous intravenous infusion for the initial 10 days of treatment in patients with proximal DVT.

Endpoints:
• Efficacy: the result of the qualitative assessment of venogram evolution between day 0 and day 10.
• Safety: was based on the incidence of major bleeding during 10 days of treatment.

Results:
134 patients were enrolled in the study; 67 patients were assigned to receive UFH and 67 to receive enoxaparin. Venograms from day 0 and day 10 were available for qualitative and quantitative assessment in 117 patients.The distribution of changes in qualitative venographic assessment showed a significant difference in favor of the enoxaparin group (p=0.002); in the UFH group, five venograms were considered worsened, 34 unchanged, and 18 improved as compared with one venogram worsened, 24 unchanged, and 35 improved in the enoxaparin group. Of overall recurrent thromboembolic events (defined by clinically suspected recurrence of venous thromboembolism confirmed by angiography and asymptomatic proximal clot extension on repeated venography) indicated a significant superiority of enoxaparin over UFH; seven patients in the UFH group showed at least one recurrent thromboembolic event vs one patient in the enoxaparin group (p<0.002).

SC: Subcutaneous, DVT: Deep Vein Thrombosis, UFH: Unfractionated Heparin

Clexane 20,40 mg API

MAT-EG-2201671/V1.0/Mar2023
EDA Approval No. BF0065OA615/022023
EDA Invalidation Date: 23/02/2025