Background: Individuals with deep vein thrombosis (DVT) have an increased risk of pulmonary embolism (PE), death, and long-term thrombotic complications.
Objectives: To evaluate the efficacy and safety of bemiparin once daily versus enoxaparin twice daily in the treatment of acute DVT, and to establish therapeutic non-inferiority of bemiparin.
Patients and methods: This multicenter, randomized, open-label, active-controlled phase III clinical trial enrolled patients with acute proximal DVT confirmed by complete compression ultrasound (CCUS). Patients received bemiparin once daily or enoxaparin twice daily subcutaneously for 7 days, in combination with warfarin 5 mg/day. Assessment of thrombotic burden was blinded and used CCUS recordings. The primary efficacy endpoint was the percentage of patients with an improvement in thrombotic burden at day 83 (end of follow-up); the secondary efficacy endpoint was the incidence of symptomatic recurrent DVT and PE. Safety endpoints included treatment-emergent adverse events.
Results: Three-hundred and twelve patients were enrolled (~ 62% male; mean age 55.2 years). At least one DVT risk factor was present in 26.1% and 28.7% of the bemiparin and enoxaparin groups, respectively. The proportion of patients who had an improvement in thrombotic burden was similar for bemiparin (78.2%) and enoxaparin [80.8%; difference - 2.66 (97.5% CI - 12.39; ∞)], as was mean change in thrombus score (- 8.8 and - 8.6, respectively). There were no cases of recurrent DVT, and one case of non-fatal symptomatic PE in each treatment group. No major bleeding was reported, and there was no difference in the incidence of non-major bleeding.
Conclusions: The efficacy of bemiparin administered once daily is non-inferior to that of enoxaparin administered twice daily with a similar safety profile. CLINICALTRIALS.
Gov identifier: NCT01880216.